2009 TNI Standard Assessment Checklist (PA-DEP Rev 1.1) TNI
This checklist is non-official and non-authorized, but should cover your basic requirements for 2009 TNI Standard. DISCLAIMER: THIS CHECKLIST IS ONLY A TOOL, NOT THE ENTIRE LIST OF REQUIREMENTS OF THE 2009 TNI STANDARD, 25 PA CODE CHAPTERS 109 AND 252, THE CODE OF FEDERAL REGULATIONS OR THE TEST METHOD. IF THERE IS A DISAGREEMENT BETWEEN THIS CHECKLIST AND THE STANDARDS, REGULATIONS OR TEST METHOD THEN THE STANDARD, REGULATION OR TEST METHOD SHALL PREVAIL.
V1M1 Proficiency Testing
1. V1M1 Proficiency Testing
To obtain initial accreditation, the laboratory shall successfully analyze two unique TNI compliant PT samples for each accreditation FoPT that correspond to the fields of accreditation for which it seeks accreditation.
Details:
Note 1: The requirements for successful PT performance are described in Volume 2, Module 2, and in Volume 3. Note 2: Accreditation and experimental FoPT are established by the TNI PT Board. The official Tables of FoPT are posted to the TNI website. V1M1: 4.1.1
2. Requirements for Accreditation: Initial Accreditation
The PT samples used for initial accreditation shall be obtained from any PTPA-accredited PTP as part of a TNI-compliant study.
Details:
V1M1: 4.1.2
3. Requirements for Accreditation: Initial Accreditation
Proficiency test studies shall be purchased at the environmental laboratory’s expense directly from suppliers approved by the Department as a proficiency test provider.
Details:
V1M1: 4.2.1.a
4. Requirements for Accreditation: Initial Accreditation
When the PT samples used for initial accreditation were analyzed by the laboratory prior to the date of application, the analysis dates of the PT samples for the same accreditation FoPT: - shall be no more than eighteen (18) months prior to the application date of accreditation, -Otherwise, there shall be at least fifteen (15) calendar days between the analysis dates of successive PT samples for the same accreditation FoPT.
Details:
252.501(e)
5. Requirements for Accreditation: Initial Accreditation
When the PT samples used for initial accreditation were analyzed by the laboratory prior to the date of application, the analysis dates of the PT samples for the same accreditation FoPT: -with the analysis date of the most recent PT sample having been no more than six (6) months prior to the application date for accreditation. -Otherwise, there shall be at least fifteen (15) calendar days between the analysis dates of successive PT samples for the same accreditation FoPT.
Details:
V1M1: 4.2.1.a
6. Requirements for Accreditation: Continued Accreditation
To maintain accreditation the laboratory shall: Analyze at least two TNI-compliant PT samples per calendar year for each accreditation FoPT for which the laboratory is accredited unless TNI-compliant PT samples are not available from any PTPA approved PT provider at least twice per year, in which case the laboratory shall analyze the PT samples in the minimum time frame in which the PT samples are available .
Details:
V1M1: 4.2.1.a
7. Requirements for Accreditation: Continued Accreditation
The analysis dates of successive PT samples for the same accreditation FoPT shall be at least five (5) months apart and no longer than seven (7) months apart unless the PT sample is being used for corrective action to reestablish successful history in order to maintain continued accreditation,
Details:
V1M1: 4.2.1.a
8. Requirements for Accreditation: Continued Accreditation
If [the PTs are] being used to reinstate accreditation after suspension, the analysis dates of successive PT samples for the same accreditation FoPT shall be at least fifteen (15) days apart;
Details:
V1M1: 4.2.1.a
9. Requirements for Accreditation: Continued Accreditation
[The laboratory shall] maintain a history of at least two (2) successful performances out of the most recent three (3) attempts; for each accreditation FoPT; and
Details:
V1M1: 4.2.1.b
10. Requirements for Accreditation: Continued Accreditation
[The laboratory shall] obtain the PT samples from any PTPA-accredited PTP.
Details:
V1M1: 4.2.1.c
11. Requirements for Accreditation: Continued Accreditation
An environmental laboratory accredited under this chapter shall successfully analyze at least one single blind, single concentration proficiency test study for each field of accreditation, when available, as specified in subsection (a), for which the laboratory is accredited at least once every 12 months.
Details:
252.501(d)
12. Requirements for Accreditation: Continued Accreditation
When a laboratory is accredited for a field of accreditation for which the FoPT is an experimental FoPT, the laboratory shall analyze two (2) PT samples for the experimental FoPT per year within the same time frames specified for accreditation FoPT. However, successful performance of the experimental PT is not a requisite for continued accreditation.
Details:
V1M1: 4.2.2
13. Requirements for PT Sample Handling, Analysis & Reporting: PT Sample Analysis Requirements
The laboratory shall analyze PT samples in the same manner as used for routine environmental samples using: --the same staff, --sample tracking, --sample preparation and analysis methods, --standard operating procedures, --calibration techniques, --quality control procedures and acceptance criteria.
Details:
Note: The laboratory is permitted to analyze the same PT sample for any accreditation or experimental FoPT by multiple methods so long as those test methods are within the same field of accreditation matrix. If the laboratory is accredited for multiple test methods that use the same technology within a field of accreditation, the laboratory is not required to analyze a PT sample for each test method, except for fields of accreditation for the drinking water accreditation matrix for which a PT sample per test method is required. The laboratory may analyze and report the PT sample by one test method and an acceptable performance score for that test method will be acceptable for all test methods that use that same technology within that field of accreditation. When the laboratory reports an analytical result for an accreditation FoPT within the same field of accreditation and accreditation matrix by more than one test method using the same technology, an unacceptable score for either test method will result in an unacceptable score for all test methods for that accreditation FoPT. V1M1: 5.1.1
14. - a. Requirements for PT Sample Handling, Analysis & Reporting: PT Sample Analysis Requirements
Prior to the closing date of a study, laboratory personnel, including corporate personnel, shall not subcontract the analysis of any PT sample or a portion of a PT sample to another laboratory for any accreditation or experimental FoPT.
Details:
V1M1: 5.1.2
15. - b. Requirements for PT Sample Handling, Analysis & Reporting: PT Sample Analysis Requirements
Prior to the closing date of a study, laboratory personnel, including corporate personnel, shall not knowingly receive and analyze any PT sample or portion of a PT sample from another laboratory for which the results of the PT sample are intended for use for initial or continued accreditation.
Details:
V1M1: 5.1.2
16. - c. Requirements for PT Sample Handling, Analysis & Reporting: PT Sample Analysis Requirements
Prior to the closing date of a study, laboratory personnel, including corporate personnel, shall not communicate with any individual at another laboratory concerning the analysis of the PT sample prior to the closing date of the study.
Details:
V1M1: 5.1.2
17. - d. Requirements for PT Sample Handling, Analysis & Reporting: PT Sample Analysis Requirements
Prior to the closing date of a study, laboratory personnel, including corporate personnel, shall not attempt to obtain the assigned value of any accreditation or experimental FoPT from the PTP.
Details:
V1M1: 5.1.2
18. Requirements for PT Sample Handling, Analysis & Reporting: PT Sample Reporting Requirements
The laboratory shall evaluate and report the analytical result for accreditation or experimental FoPT as follows: For instrument technology that employs a multi-point calibration, the laboratory shall evaluate the analytical result to the value of the lowest calibration standard established for the test method used to analyze the PT sample.
Details:
V1M1: 5.2.1.a
19. Requirements for PT Sample Handling, Analysis & Reporting: PT Sample Reporting Requirements
The laboratory shall evaluate and report the analytical result for accreditation or experimental FoPT as follows: The working range of the calibration under which the PT sample is analyzed shall be the same range as used for routine environmental samples.
Details:
V1M1: 5.2.1.a
20. Requirements for PT Sample Handling, Analysis & Reporting: PT Sample Reporting Requirements
The laboratory shall evaluate and report the analytical result for accreditation or experimental FoPT as follows: A result for any FoPT at a concentration above or equal to the lowest calibration standard shall be reported as the resultant value.
Details:
V1M1: 5.2.1.a
21. Requirements for PT Sample Handling, Analysis & Reporting: PT Sample Reporting Requirements
The laboratory shall evaluate and report the analytical result for accreditation or experimental FoPT as follows: A result for any FoPT at a concentration less than the lowest calibration standard shall be reported as less than the value of the lowest calibration standard.
Details:
V1M1: 5.2.1.a
22. Requirements for PT Sample Handling, Analysis & Reporting: PT Sample Reporting Requirements
The laboratory shall evaluate and report the analytical result for accreditation or experimental FoPT as follows: For instrument technology (such as ICP-AES or ICP-MS) that employ standardization with a zero point and a single point calibration standard, the laboratory shall evaluate the analytical result to the limit of quantitation (LOQ) established for the test method used to analyze the PT sample.
Details:
V1M1: 5.2.1.b
23. Requirements for PT Sample Handling, Analysis & Reporting: PT Sample Reporting Requirements
The laboratory shall evaluate and report the analytical result for accreditation or experimental FoPT as follows: The LOQ for the FoPT shall be the same as used for routine environmental samples.
Details:
V1M1: 5.2.1.b
24. Requirements for PT Sample Handling, Analysis & Reporting: PT Sample Reporting Requirements
The laboratory shall evaluate and report the analytical result for accreditation or experimental FoPT as follows: A result for any FoPT at a concentration above or equal to the LOQ shall be reported as the resultant value.
Details:
V1M1: 5.2.1.b
25. Requirements for PT Sample Handling, Analysis & Reporting: PT Sample Reporting Requirements
The laboratory shall evaluate and report the analytical result for accreditation or experimental FoPT as follows: A result for any FoPT at a concentration less than the LOQ shall be reported as less than the value of the LOQ.
Details:
Note: The definitions and requirements for calibration and limit of quantitation are included in Volume 1, Module 2. V1M1: 5.2.1.b
26. Requirements for PT Sample Handling, Analysis & Reporting: PT Sample Reporting Requirements
An environmental laboratory shall evaluate and report the analytical result of each proficiency test study sample to the proficiency test reporting limit for each field of accreditation, when available.
Details:
Chapter 252 Implementation Note: With the exception of drinking water PT samples, the PA-DEP LAP will allow laboratories to choose to report PT samples either to the laboratory's LOQ or the FoPT's PTRL (as established by the TNI FoPT Tables). If a laboratory chooses to report PT samples to the PTRL, the laboratory must demonstrate that these results would have been reported with an appropriate data qualifier (to establish that PT samples are reported like real environmental samples). Should the laboratory choose to report samples with "s PT history. 252.501(o)
27. Requirements for PT Sample Handling, Analysis & Reporting: PT Sample Reporting Requirements
An environmental laboratory seeking to obtain or maintain accreditation in the drinking water matrix shall participate in proficiency test studies that meet the requirements of 40 CFR Part 141 (relating to national primary drinking water regulations).
Details:
Chapter 252 Implementation Note: In accordance with 40 CFR Part 141, environmental laboratories must report drinking water PTs to the established PTRLs. 252.501(n)
28. Requirements for PT Sample Handling, Analysis & Reporting: PT Sample Reporting Requirements
The laboratory shall report the analytical results for accreditation and experimental FoPTs to the PTP on or before the closing date of the study using the reporting format specified by the PTP.
Details:
V1M1: 5.2.2
29. Requirements for PT Sample Handling, Analysis & Reporting: PT Sample Reporting Requirements
On or before the closing date of the study, the laboratory shall authorize the PTP to release the laboratory’s final evaluation report directly to the laboratory’s Primary AB.
Details:
V1M1: 5.2.3
30. Requirements for PT Sample Handling, Analysis & Reporting: PT Sample Reporting Requirements
An environmental laboratory shall direct the proficiency test study provider to report the proficiency test study performance results directly to the Department’s Laboratory Accreditation Program at the same time that the provider reports the results to the environmental laboratory.
Details:
252.501(l)
31. Requirements for PT Sample Handling, Analysis & Reporting: PT Sample Record Retention Requirements
The laboratory shall retain all records necessary to facilitate historical reconstruction of the analysis and reporting of analytical results for PT samples for a minimum of five years.
Details:
V1M1: 5.3.1
32. Requirements for PT Sample Handling, Analysis & Reporting: PT Sample Record Retention Requirements
The historical records shall include a copy of the reporting forms used by the laboratory to report the analytical results for PT samples to the PTP.
Details:
V1M1: 5.3.2
33. Requirements for PT Sample Handling, Analysis & Reporting: PT Sample Record Retention Requirements
If the analytical results for the PT samples were entered or uploaded electronically to a PTP website, the laboratory shall retain a copy of the on-line data entry summary or similar documentation of entry of the PT results from the PTP's website.
Details:
V1M1: 5.3.2
34. Requirements for PT Sample Handling, Analysis & Reporting: PT Sample Record Retention Requirements
The laboratory shall make these records available for review upon request by the Primary AB.
Details:
V1M1: 5.3.3
35. Requirements for Corrective Action
When the laboratory receives a “not acceptable” performance score from a PTP or a Primary AB, the laboratory shall perform corrective action.
Details:
V1M1: 6.1
36. Requirements for Corrective Action
If an environmental laboratory fails to successfully analyze a proficiency test study for an individual field of accreditation, it shall determine the cause for the failure and take any necessary corrective action.
Details:
252.501(k)
37. Requirements for Corrective Action
The laboratory shall document the investigation and corrective action.
Details:
252.501(k)
38. Requirements for Corrective Action
The requirements for corrective action are described in Volume 1, Module 2. When the laboratory receives an evaluation of not acceptable for an accreditation FoPT in any study, the laboratory may choose to re-establish successful history for the accreditation FoPT with a PT sample from any study.
Details:
V1M1: 6.1
39. Requirements for Corrective Action
The following requirements shall apply to the PT sample used to reestablish successful history: The PT sample shall be obtained from any PTPA–accredited PTP unless there are not any PTPA-accredited PTP for the FoPT in which case the PT sample may be purchased from any PTP.
Details:
V1M1: 6.1.a
40. Requirements for Corrective Action
The following requirements shall apply to the PT sample used to reestablish successful history: The laboratory shall notify the PTP that the PT sample will be used for corrective action purposes so the PTP may ensure that the PT sample supplied meets the requirements for supplemental PT as defined in Volume 3 of this standard.
Details:
V1M1: 6.1.a
41. Requirements for Corrective Action
The following requirements shall apply to the PT sample used to reestablish successful history: The laboratory shall ensure that there are at least fifteen calendar days between the analysis dates of successive PT samples for the same accreditation FoPT.
Details:
V1M1: 6.1.b
42. Requirements for Corrective Action
The following requirements shall apply to the PT sample used to reestablish successful history: The PT sample shall be analyzed and reported in accordance with the requirements described this Module.
Details:
V1M1: 6.1.c
43. Requirements for Complaint Resolution
The laboratory shall submit questions about PT samples or performance evaluations made by the PTP to the PTP.
Details:
V1M1: 7.1
44. Requirements for Complaint Resolution
If the PTP is not able or is unwilling to resolve the question to the satisfaction of the laboratory, the laboratory shall refer those questions to the PTP’s PTPA.
Details:
V1M1: 7.1
45. Reqirements for Accreditation After Suspension or Revocation
To reinstate accreditation for an accreditation FoPT after suspension, the laboratory shall meet the requirements for continued accreditation as described in Section 4.2 of this module.
Details:
V1M1: 8.1
46. Reqirements for Accreditation After Suspension or Revocation
To reinstate accreditation for an accreditation FoPT after revocation, the laboratory shall meet the requirements for initial accreditation as described in Section 4.1 of this module.
Details:
V1M1: 8.2
47. Chapter 252 Miscellaneous Provisions: Denial of Application
The Department may deny an application for accreditation, transfer of accreditation or application for renewal of accreditation for one or more of the following reasons: (5) Analysis of proficiency test studies by personnel other than the analysts associated with the routine analysis of environmental samples in the laboratory. (9) Failure to successfully analyze and report proficiency test studies as required by this chapter.
Details:
252.701(b)
48. Chapter 252 Miscellaneous Provisions: Revocation
The Department will revoke an environmental laboratory’s accreditation for a field of accreditation when, after being suspended due to failure to participate in a required proficiency test study or due to failure to obtain an acceptable result for a proficiency test study, the laboratory’s analysis of the next proficiency test study results in a failed proficiency test study for that field of accreditation.
Details:
252.702(a)
49. Chapter 252 Miscellaneous Provisions: Revocation
The Department may revoke an environmental laboratory’s accreditation, in part or in total, for one or more of the following reasons: (11) Analysis of proficiency test studies by personnel other than the analysts associated with the routine analysis of environmental samples in the laboratory.
Details:
252.702(b)
50. Chapter 252 Miscellaneous Provisions: Suspension
The Department will suspend an environmental laboratory’s accreditation in total or in part for one or more of the following reasons: (2) The environmental laboratory fails to successfully complete a proficiency test study within the previous 12 months. (3) The environmental laboratory fails two consecutive proficiency test studies for a field of accreditation.
Details:
252.703(b)
V1M2 General Requirements
1. Use of Accreditation
Environmental laboratories accredited by the Department shall post or display their most recent certificate of accreditation in a prominent place in the laboratory.
Details:
252.705(a)
2. Use of Accreditation
Environmental laboratories accredited by the Department shall make accurate statements concerning their accreditation status.
Details:
252.705(a)
3. Use of Accreditation
Environmental laboratories accredited by the Department shall not use their certificate of accreditation, accreditation status, or the Department's logo to imply endorsement by the Department.
Details:
252.705(a)
4. Use of Accreditation
Upon suspension, revocation or voluntary relinquishment of accreditation, a laboratory shall discontinue use of all catalogs, advertising, business solicitations, proposals, quotations, laboratory analytical results or other materials that contain reference to the laboratory’s past accreditation status.
Details:
252.705(c)
5. Use of Accreditation
Upon suspension, revocation or voluntary relinquishment of accreditation, a laboratory shall discontinue use or display of the Department’s logo.
Details:
252.705(c)
6. Use of Accreditation
Upon suspension, revocation or voluntary relinquishment of accreditation, a laboratory shall return certificates of accreditation to the Department within 48 hours.
Details:
252.705(c)
7. Use of Accreditation
NELAP accredited laboratories shall accompany the Department’s name or the NELAC/NELAP logo with the phrase ‘‘NELAP accredited’’ and the laboratory’s accreditation number when using the Department’s name or the NELAC/NELAP logo on general literature such as catalogs, advertising, business solicitations, proposals, quotations, laboratory analytical reports or other materials.
Details:
252.705(d)
8. Use of Accreditation
NELAP accredited laboratories may not use their NELAP certificate, NELAP accreditation status or NELAC/NELAP logo to imply endorsement by the Department or NELAC.
Details:
252.705(e)
9. Reporting and Notification Requirements
An environmental laboratory shall notify the Department, in writing, within 20 calendar days of a permanent change in laboratory supervisor.
Details:
252.708(b)
10. Reporting and Notification Requirements
An environmental laboratory shall notify the Department, in writing, within 30 calendar days of a change in the legal name of the laboratory.
Details:
252.708(c)
11. Reporting and Notification Requirements
An environmental laboratory shall notify the Department, in writing, within 30 calendar days of a change in any item contained on the application for accreditation.
Details:
252.708(d)
12. Reporting and Notification Requirements
An environmental laboratory shall notify the Department, in writing, if a change in the laboratory’s capability to produce valid analytical results persists for more than 90 calendar days for any field of accreditation listed on the laboratory’s scope of accreditation.
Details:
252.708(e)
13. Reporting and Notification Requirements
An out-of-State environmental laboratory with either primary or secondary accreditation from the Department shall notify, in writing, the Department within 48 hours of any changes in the laboratory’s accreditation status from any other primary accreditation body.
Details:
252.708(f)
14. SDWA Reporting and Notification Requirements
An environmental laboratory conducting testing or analysis of drinking water under Chapter 109 (relating to safe drinking water) shall meet the reporting and notification requirements of that chapter.
Details:
Note: The following requirements are specific reporting and notification requirements under Chapter 109 and only apply to the testing or analysis of drinking water samples. 252.708(a)
15. SDWA Reporting and Notification Requirements
An environmental laboratory conducting testing or analysis of drinking water under Chapter 109 (relating to safe drinking water) shall review all sample analysis data within 24 hours of acquisition of the initial sample results for microbiological, inorganic nonmetals and trace metals analyses. The 24-hour deadline may be extended to a maximum of 72 hours to accommodate a holiday or weekend when the laboratory is closed for business.
Details:
Note: The following requirements are specific reporting and notification requirements under Chapter 109 and only apply to the testing or analysis of drinking water samples. 252.708(a)
16. SDWA Reporting and Notification Requirements
An environmental laboratory conducting testing or analysis of drinking water under Chapter 109 (relating to safe drinking water) shall, for organic analyses, review all sample analysis data within 7 days of acquisition of the initial sample results for organic analysis.
Details:
Note: The following requirements are specific reporting and notification requirements under Chapter 109 and only apply to the testing or analysis of drinking water samples. 252.708(a)
17. SDWA Reporting and Notification Requirements
Unless a different reporting period is specified in Chapter 109, results shall be reported within either the first 10 days following the month in which the result is determined or the first 10 days following the end of the required monitoring period as stipulated by the Department, whichever is shorter.
Details:
Note: The following requirements are specific reporting and notification requirements under Chapter 109 and only apply to the testing or analysis of drinking water samples. 109.810(a)(1)
18. SDWA Reporting and Notification Requirements
The laboratory shall when a MCL, MRDL or a treatment technique performance requirement under 40CFR-109 202 is exceeded, or an action level under 40CFR-109 1102(a) is exceeded, or a sample result requires the collection of check or confirmation samples under 40CFR-109 301, or a sample collected under Subchapter M is E. coli-positive: Notify the public water supplier by telephone within 1 hour of the laboratory's determination.
Details:
Note: The following requirements are specific reporting and notification requirements under Chapter 109 and only apply to the testing or analysis of drinking water samples. Additional Info: -If the supplier cannot be reached within that time frame, notify the Department by telephone within 2 hours of the determination. -If it is necessary for the laboratory to contact the Department after the Department's routine business hours, the laboratory shall: -contact the appropriate Department regional office's after-hours emergency response telephone number and provide: -provide information regarding the occurrence, the name of a contact person and the telephone number where that individual may be reached in the event further information is needed. -If the Department's appropriate emergency number cannot be reached, the laboratory shall notify the appropriate Department regional office by telephone within 1 hour of the beginning of the next business day. 109.810(b)
19. SDWA Reporting and Notification Requirements
Each accredited laboratory shall be responsible for the laboratory shall obtain and maintain the Department's current after-hours emergency response telephone numbers for each applicable regional office.
Details:
Note: The following requirements are specific reporting and notification requirements under Chapter 109 and only apply to the testing or analysis of drinking water samples. Additional Info: 109.810(b)(1)
20. SDWA Reporting and Notification Requirements
Each accredited laboratory shall be responsible for the laboratory shall establish and update an SOP by November 8, 2002, and at least annually thereafter to profide the information needed to report the occurrences to the Department.
Details:
Note: The following requirements are specific reporting and notification requirements under Chapter 109 and only apply to the testing or analysis of drinking water samples. Additional Info: 109.810(b)(1)
21. SDWA Reporting and Notification Requirements
The SOP [used to provide occurrences to the Department] must contain, but is not limited to: The PWSID number of the system
Details:
Note: The following requirements are specific reporting and notification requirements under Chapter 109 and only apply to the testing or analysis of drinking water samples. Additional Info: 109.810(b)(1)(ii)
22. SDWA Reporting and Notification Requirements
The SOP [used to provide occurrences to the Department] must contain, but is not limited to: The system's name
Details:
Note: The following requirements are specific reporting and notification requirements under Chapter 109 and only apply to the testing or analysis of drinking water samples. Additional Info: 109.810(b)(1)(ii)
23. SDWA Reporting and Notification Requirements
The SOP [used to provide occurrences to the Department] must contain, but is not limited to: The contaminant involved in the occurrence
Details:
Note: The following requirements are specific reporting and notification requirements under Chapter 109 and only apply to the testing or analysis of drinking water samples. Additional Info: 109.810(b)(1)(ii)
24. SDWA Reporting and Notification Requirements
The SOP [used to provide occurrences to the Department] must contain, but is not limited to: The level of the contaminant found
Details:
Note: The following requirements are specific reporting and notification requirements under Chapter 109 and only apply to the testing or analysis of drinking water samples. Additional Info: 109.810(b)(1)(ii)
25. SDWA Reporting and Notification Requirements
The SOP [used to provide occurrences to the Department] must contain, but is not limited to: Where the sample was collected
Details:
Note: The following requirements are specific reporting and notification requirements under Chapter 109 and only apply to the testing or analysis of drinking water samples. Additional Info: 109.810(b)(1)(ii)
26. SDWA Reporting and Notification Requirements
The SOP [used to provide occurrences to the Department] must contain, but is not limited to: The dates and times that the sample was collected and analyzed
Details:
Note: The following requirements are specific reporting and notification requirements under Chapter 109 and only apply to the testing or analysis of drinking water samples. Additional Info: 109.810(b)(1)(ii)
27. SDWA Reporting and Notification Requirements
The SOP [used to provide occurrences to the Department] must contain, but is not limited to: The name and identification number of the certified laboratory
Details:
Note: The following requirements are specific reporting and notification requirements under Chapter 109 and only apply to the testing or analysis of drinking water samples. Additional Info: 109.810(b)(1)(ii)
28. SDWA Reporting and Notification Requirements
The SOP [used to provide occurrences to the Department] must contain, but is not limited to: The name and telephone number of a contact person at the laboratory
Details:
Note: The following requirements are specific reporting and notification requirements under Chapter 109 and only apply to the testing or analysis of drinking water samples. Additional Info: 109.810(b)(1)(ii)
29. SDWA Reporting and Notification Requirements
The SOP [used to provide occurrences to the Department] must contain, but is not limited to: What steps the laboratory took to contact the public water system before calling the Department
Details:
Note: The following requirements are specific reporting and notification requirements under Chapter 109 and only apply to the testing or analysis of drinking water samples. Additional Info: 109.810(b)(1)(ii)
30. SDWA Reporting and Notification Requirements
The laboratory shall notify the Department district office in writing within 24 hours of the determination.
Details:
Note: The following requirements are specific reporting and notification requirements under Chapter 109 and only apply to the testing or analysis of drinking water samples. Additional Info: 109.810(b)(2)
31. SDWA Reporting and Notification Requirements
A laboratory accredited under Chapter 252 shall meet the requirements under subsections (a) and (b), regarding the results of test measurements or analyses performed by the laboratory under Chapter 109, unless the laboratory assigns in writing the responsibility for reporting and notification to another accredited laboratory.
Details:
Note: The following requirements are specific reporting and notification requirements under Chapter 109 and only apply to the testing or analysis of drinking water samples. Additional Info: 109.810(c)
32. SDWA Reporting and Notification Requirements
The laboratory shall be responsible for the accurate reporting of data required under § 109.810 to the Department.
Details:
Note: The following requirements are specific reporting and notification requirements under Chapter 109 and only apply to the testing or analysis of drinking water samples. Additional Info: 109.810(d)
V1M2 Management Requirements
1. Organization
The laboratory or the organization of which it is part shall be an entity that can be held legally responsible.
Details:
V1M2: 4.1.1
2. Organization
It is the responsibility of the laboratory to carry out its testing and calibration activities in such a way as to meet the requirements of this International Standard.
Details:
V1M2: 4.1.2
3. Organization
It is the responsibility of the laboratory to carry out its testing and calibration activities in such a way as to satisfy the needs of the customer, the regulatory authorities or organizations providing recognition.
Details:
V1M2: 4.1.2
4. Organization
The management system shall cover work carried out in the laboratory's permanent facilities, at sites away from its permanent facilities, or in associated temporary or mobile facilities.
Details:
V1M2: 4.1.3
5. Organization
If the laboratory is part of an organization performing activities other than testing and/or calibration, the responsibilities of key personnel in the organization that have an involvement or influence on the testing and/or calibration activities of the laboratory shall be defined in order to identify potential conflicts of interest.
Details:
NOTE 1: Where a laboratory is part of a larger organization, the organizational arrangements should be such that departments having conflicting interests, such as production, commercial marketing or financing do not adversely influence the laboratory's compliance with the requirements of this International Standard. NOTE 2: If the laboratory wishes to be recognized as a third-party laboratory, it should be able to demonstrate that it is impartial and that it and its personnel are free from any undue commercial, financial and other pressures which might influence their technical judgment. The third-party testing or calibration laboratory should not engage in any activities that may endanger the trust in its independence of judgment and integrity in relation to its testing or calibration activities. Additional Info: V1M2: 4.1.4
6. Organization
The laboratory shall have managerial and technical personnel who, irrespective of other responsibilities, have the authority and resources needed to carry out their duties, including: --have managerial and technical personnel who have the authority and resources needed to carry out the implementation, maintenance and improvement of the management system, --have managerial and technical personnel who have the authority and resources needed to identify the occurrence of departures from the management system or from the procedures for performing tests and/or calibrations --have managerial and technical personnel who have the authority and resources needed to initiate actions to prevent or minimize such departures (see also 5.2);
Details:
NOTE: Individuals may have more than one function and it may be impractical to appoint deputies for every function. Additional Info: V1M2: 4.1.5
7. Organization
The laboratory shall have arrangements to ensure that its management and personnel are free from any undue internal and external commercial, financial and other pressures and influences that may adversely affect the quality of their work;
Details:
NOTE: Individuals may have more than one function and it may be impractical to appoint deputies for every function. Additional Info: V1M2: 4.1.5
8. Organization
The laboratory shall have policies and procedures to ensure the protection of its customers' confidential information and proprietary rights, including procedures for protecting the electronic storage and transmission of results;
Details:
NOTE: Individuals may have more than one function and it may be impractical to appoint deputies for every function. Additional Info: V1M2: 4.1.5
9. Organization
The laboratory shall have policies and procedures to avoid involvement in any activities that would diminish confidence in its competence, impartiality, judgment or operational integrity;
Details:
NOTE: Individuals may have more than one function and it may be impractical to appoint deputies for every function. Additional Info: V1M2: 4.1.5
10. Organization
The laboratory shall define the organization and management structure of the laboratory, its place in any parent organization, and the relationships between quality management, technical operations and support services;
Details:
NOTE: Individuals may have more than one function and it may be impractical to appoint deputies for every function. Additional Info: V1M2: 4.1.5
11. Organization
The laboratory shall specify the responsibility, authority and interrelationships of all personnel who manage, perform or verify work affecting the quality of the tests and/or calibrations;
Details:
NOTE: Individuals may have more than one function and it may be impractical to appoint deputies for every function. Additional Info: V1M2: 4.1.5
12. Organization
The laboratory shall provide adequate supervision of testing and calibration staff, including trainees, by persons familiar with methods and procedures, purpose of each test and/or calibration, and with the assessment of the test or calibration results;
Details:
NOTE: Individuals may have more than one function and it may be impractical to appoint deputies for every function. Additional Info: V1M2: 4.1.5
13. Organization
The laboratory shall have technical management which has overall responsibility for the technical operations and the provision of the resources needed to ensure the required quality of laboratory operations;
Details:
NOTE: Individuals may have more than one function and it may be impractical to appoint deputies for every function. Additional Info: V1M2: 4.1.5
14. Organization
The laboratory shall appoint a member of staff as quality manager (however named) who, irrespective of other duties and responsibilities, shall have defined responsibility and authority for ensuring that the management system related to quality is implemented and followed at all ; the quality manager shall have direct access to the highest level of management at which decisions are made on laboratory policy or resources;
Details:
NOTE: Individuals may have more than one function and it may be impractical to appoint deputies for every function. Additional Info: V1M2: 4.1.5
15. Organization
The laboratory shall appoint deputies for key managerial personnel (see Note);
Details:
NOTE: Individuals may have more than one function and it may be impractical to appoint deputies for every function. Additional Info: V1M2: 4.1.5
16. Organization
The laboratory shall ensure that its personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the objectives of the management system.
Details:
NOTE: Individuals may have more than one function and it may be impractical to appoint deputies for every function. Additional Info: V1M2: 4.1.5
17. Organization
Top management shall ensure that appropriate communication processes are established within the laboratory and that communication takes place regarding the effectiveness of the management system.
Details:
V1M2: 4.1.6
18. Additional Requirements for Laboratories
The laboratory's quality manager and/or his/her designee(s) shall serve as the focal point for QA/QC and be responsible for the oversight and/or review of quality control data;
Details:
NOTE: Where staffing is limited, the quality manager may also be the technical manager. Additional Info: V1M2: 4.1.7.1
19. Additional Requirements for Laboratories
The laboratory's quality manager and/or his/her designee(s) shall have functions independent from laboratory operations for which they have quality assurance oversight;
Details:
NOTE: Where staffing is limited, the quality manager may also be the technical manager. Additional Info: V1M2: 4.1.7.1
20. Additional Requirements for Laboratories
The laboratory's quality manager and/or his/her designee(s) shall be able to evaluate data objectively and perform assessments without outside (e.g., managerial) influence
Details:
NOTE: Where staffing is limited, the quality manager may also be the technical manager. Additional Info: V1M2: 4.1.7.1
21. Additional Requirements for Laboratories
The laboratory's quality manager and/or his/her designee(s) shall have documented training and/or experience in QA/QC procedures and the laboratory’s quality system
Details:
NOTE: Where staffing is limited, the quality manager may also be the technical manager. Additional Info: V1M2: 4.1.7.1
22. Additional Requirements for Laboratories
The laboratory's quality manager and/or his/her designee(s) shall have a general knowledge of the analytical methods for which data review is performed.
Details:
NOTE: Where staffing is limited, the quality manager may also be the technical manager. Additional Info: V1M2: 4.1.7.1
23. Additional Requirements for Laboratories
The laboratory's quality manager and/or his/her designee(s) shall arrange for or conduct internal audits as per Section 4.14 annually.
Details:
NOTE: Where staffing is limited, the quality manager may also be the technical manager. Additional Info: V1M2: 4.1.7.1
24. Additional Requirements for Laboratories
The laboratory's quality manager and/or his/her designee(s) shall notify laboratory management of deficiencies in the quality system.
Details:
NOTE: Where staffing is limited, the quality manager may also be the technical manager. Additional Info: V1M2: 4.1.7.1
25. Additional Requirements for Laboratories
The laboratory's quality manager and/or his/her designee(s) shall monitor corrective actions.
Details:
NOTE: Where staffing is limited, the quality manager may also be the technical manager. Additional Info: V1M2: 4.1.7.1
26. Additional Requirements for Laboratories
The laboratory's technical manager(s), however named, and/or his/her designee(s) shall be a member of the staff of an environmental laboratory who exercises actual day-to-day supervision of laboratory operations for the appropriate fields of accreditation and reporting of results.
Details:
V1M2: 4.1.7.2
27. Additional Requirements for Laboratories
The laboratory's technical manager(s), however named, and/or his/her designee(s) shall be experienced in the fields of accreditation for which the laboratory is seeking accreditation.
Details:
V1M2: 4.1.7.2
28. Additional Requirements for Laboratories
The laboratory's technical manager(s), however named, and/or his/her designee(s) shall have duties that include: i) monitoring standards of performance in quality control and quality assurance, and ii) monitoring the validity of the analyses performed and data generated in the laboratory to assure reliable data.
Details:
V1M2: 4.1.7.2
29. Additional Requirements for Laboratories
The laboratory's technical manager(s), however named, and/or his/her designee(s) shall not be the technical manager(s) of more than one accredited environmental laboratory without authorization from the primary Accreditation Body.
Details:
Circumstances to be considered in the decision to grant such authorization shall include: i) the extent to which operating hours of the laboratories to be directed overlap, ii) adequacy of supervision in each laboratory, and iii) the availability of environmental laboratory services in the area served. Additional Info: V1M2: 4.1.7.2
30. Additional Requirements for Laboratories
If absent for a period of time exceeding fifteen (15) consecutive calendar days shall designate another full-time staff member meeting the qualifications of the technical manager(s) to temporarily perform this function.
Details:
V1M2: 4.1.7.2
31. Additional Requirements for Laboratories
If this absence exceeds thirty-five (35) consecutive calendar days, the primary accreditation body shall be notified in writing; and meet qualification requirements as specified in Section 5.2.6.1.
Details:
V1M2: 4.1.7.2
32. Management
The laboratory shall establish, implement and maintain a management system appropriate to the scope of its activities.
Details:
V1M2: 4.2.1
33. Management
The laboratory shall document its policies, systems, programmes, procedures and instructions to the extent necessary to assure the quality of the test and/or calibration results.
Details:
V1M2: 4.2.1
34. Management
The system's documentation shall be communicated to, understood by, available to, and implemented by the appropriate personnel.
Details:
V1M2: 4.2.1
35. Management
The laboratory's management system policies related to quality, including a quality policy statement, shall be defined in a quality manual (however named).
Details:
V1M2: 4.2.2
36. Management
The overall objectives shall be established, and shall be reviewed during management review. The quality policy statement shall be issued under the authority of top management.
Details:
V1M2: 4.2.2
37. Organization
The laboratory or the organization of which it is part shall be an entity that can be held legally responsible.
Details:
V1M2: 4.1.1
38. Management
The quality policy statement shall include at least the following: the laboratory management's commitment to good professional practice and to the quality of its testing and calibration in servicing its customers.
Details:
NOTE: The quality policy statement should be concise and may include the requirement that tests and/or calibrations shall always be carried out in accordance with stated methods and customers' requirements. When the test and/or calibration laboratory is part of a larger organization, some quality policy elements may be in other documents. Additional Info: V1M2: 4.2.2
39. Management
The quality policy statement shall include at least the following: the management's statement of the laboratory's standard of service.
Details:
NOTE: The quality policy statement should be concise and may include the requirement that tests and/or calibrations shall always be carried out in accordance with stated methods and customers' requirements. When the test and/or calibration laboratory is part of a larger organization, some quality policy elements may be in other documents. Additional Info: V1M2: 4.2.2
40. Management
The quality policy statement shall include at least the following: the purpose of the management system related to quality.
Details:
NOTE: The quality policy statement should be concise and may include the requirement that tests and/or calibrations shall always be carried out in accordance with stated methods and customers' requirements. When the test and/or calibration laboratory is part of a larger organization, some quality policy elements may be in other documents. Additional Info: V1M2: 4.2.2
41. Management
The quality policy statement shall include at least the following: a requirement that all personnel concerned with testing and calibration activities within the laboratory familiarize themselves with the quality documentation and implement the policies and procedures in their work.
Details:
NOTE: The quality policy statement should be concise and may include the requirement that tests and/or calibrations shall always be carried out in accordance with stated methods and customers' requirements. When the test and/or calibration laboratory is part of a larger organization, some quality policy elements may be in other documents. Additional Info: V1M2: 4.2.2
42. Management
The quality policy statement shall include at least the following: the laboratory management's commitment to comply with this International Standard and to continually improve the effectiveness of the management system.
Details:
NOTE: The quality policy statement should be concise and may include the requirement that tests and/or calibrations shall always be carried out in accordance with stated methods and customers' requirements. When the test and/or calibration laboratory is part of a larger organization, some quality policy elements may be in other documents. Additional Info: V1M2: 4.2.2
43. Management
Top management shall provide evidence of commitment to the development and implementation of the management system and to continually improving its effectiveness.
Details:
V1M2: 4.2.3
44. Management
Top management shall communicate to the organization the importance of meeting customer requirements as well as statutory and regulatory requirements.
Details:
V1M2: 4.2.4
45. Management
The quality manual shall include or make reference to the supporting procedures including technical procedures. It shall outline the structure of the documentation used in the management system.
Details:
V1M2: 4.2.5
46. Management
The roles and responsibilities of technical management and the quality manager, including their responsibility for ensuring compliance with this International Standard, shall be defined in the quality manual.
Details:
V1M2: 4.2.6
47. Management
Top management shall ensure that the integrity of the management system is maintained when changes to the management system are planned and implemented.
Details:
V1M2: 4.2.7
48. Personnel
The laboratory management shall ensure the competence of all who operate specific equipment, perform tests and/or calibrations, evaluate results, and sign test reports and calibration certificates.
Details:
V1M2: 5.2.1
49. Personnel
When using staff who are undergoing training, appropriate supervision shall be provided.
Details:
V1M2: 5.2.1
50. Personnel
Personnel performing specific tasks shall be qualified on the basis of appropriate education, training, experience and/or demonstrated skills, as required.
Details:
NOTE 1: In some technical areas (e.g. non-destructive testing) it may be required that the personnel performing certain tasks hold personnel certification. The laboratory is responsible for fulfilling specified personnel certification requirements. The requirements for personnel certification might be regulatory, included in the standards for the specific technical field, or required by the customer. NOTE 2: The personnel responsible for the opinions and interpretation included in test reports should, in addition to the appropriate qualifications, training, experience and satisfactory knowledge of the testing carried out, also have: — relevant knowledge of the technology used for the manufacturing of the items, materials, products, etc. tested, or the way they are used or intended to be used, and of the defects or degradations which may occur during or in service; — knowledge of the general requirements expressed in the legislation and standards; and — an understanding of the significance of deviations found with regard to the normal use of the items, materials, products, etc. concerned. Additional Info: V1M2: 5.2.1
51. Personnel
The management of the laboratory shall formulate the goals with respect to the education, training and skills of the laboratory personnel.
Details:
V1M2: 5.2.2
52. Personnel
The laboratory shall have a policy and procedures for identifying training needs and providing training of personnel.
Details:
V1M2: 5.2.2
53. Personnel
The training programme shall be relevant to the present and anticipated tasks of the laboratory.
Details:
V1M2: 5.2.2
54. Personnel
The effectiveness of the training actions taken shall be evaluated.
Details:
V1M2: 5.2.2
55. Personnel
The laboratory shall use personnel who are employed by, or under contract to, the laboratory.
Details:
V1M2: 5.2.3
56. Personnel
Where contracted and additional technical and key support personnel are used, the laboratory shall ensure that such personnel are supervised and competent and that they work in accordance with the laboratory's management system.
Details:
V1M2: 5.2.3
57. Personnel
The laboratory shall maintain current job descriptions for managerial, technical and key support personnel involved in tests and/or calibrations.
Details:
NOTE: Job descriptions can be defined in many ways. As a minimum, the following should be defined: — the responsibilities with respect to performing tests and/or calibrations; — the responsibilities with respect to the planning of tests and/or calibrations and evaluation of results; — the responsibilities for reporting opinions and interpretations; — the responsibilities with respect to method modification and development and validation of new methods; — expertise and experience required; — qualifications and training programmes; — managerial duties. Additional Info: V1M2: 5.2.4
58. Personnel
The management shall authorize specific personnel to perform particular types of sampling, test and/or calibration, to issue test reports and calibration certificates, to give opinions and interpretations and to operate particular types of equipment.
Details:
V1M2: 5.2.5
59. Personnel
The laboratory shall maintain records of the relevant authorization(s), competence, educational and professional qualifications, training, skills and experience of all technical personnel, including contracted personnel.
Details:
V1M2: 5.2.5
60. Personnel
This information shall be readily available and shall include the date on which authorization and/or competence is confirmed.
Details:
NOTE: All references to Calibration Certificates in ISO/IEC 17025:2005(E) are not applicable to environmental testing. Additional Info: V1M2: 5.2.5
61. Additional Management System Requirements
The laboratory shall establish and maintain a documented data integrity system. There are four required elements within a data integrity system. These are: 1) data Integrity training. 2) signed data integrity documentation for all laboratory employees, 3) in-depth, periodic monitoring of data integrity, 4) data integrity procedure documentation
Details:
V1M2: 4.2.8.1
62. Additional Management System Requirements
The data integrity procedures shall be signed and dated by top management
Details:
V1M2: 4.2.8.1
63. Additional Management System Requirements
Management shall annually review data integrity procedures and update as needed.
Details:
V1M2: 4.2.8.1
64. Additional Management System Requirements
Laboratory management shall provide a procedure for confidential reporting of data integrity issues in their laboratory. A primary element of the procedure is to assure confidentiality and a receptive environment in which all employees may privately discuss ethical issues or report items of ethical concern.
Details:
V1M2: 4.2.8.1.a
65. Additional Management System Requirements
In instances of ethical concern, the procedure shall include a process whereby laboratory management is to be informed of the need for any further detailed investigation.
Details:
V1M2: 4.2.8.1.b
66. Additional Management System Requirements
The quality manager shall be responsible for maintaining the currency of the quality manual.
Details:
V1M2: 4.2.8.2
67. Additional Management System Requirements
The quality manual shall contain document title.
Details:
V1M2: 4.2.8.3
68. Additional Management System Requirements
The quality manual shall contain laboratory's full name and address.
Details:
V1M2: 4.2.8.3
69. Additional Management System Requirements
The quality manual shall contain name, address (if different from above), and telephone number of individual(s) responsible for the laboratory.
Details:
V1M2: 4.2.8.3
70. Additional Management System Requirements
The quality manual shall contain identification of all major organizational units which are to be covered by this quality manual and the effective date of the version.
Details:
V1M2: 4.2.8.3
71. Additional Management System Requirements
The quality manual shall contain identification of the laboratory's approved signatories.
Details:
V1M2: 4.2.8.3
72. Additional Management System Requirements
The quality manual shall contain the signed and dated concurrence (with appropriate names and titles), of all responsible parties including the quality manager(s), technical manager(s), and the agent who is in charge of all laboratory activities, such as the laboratory director or laboratory manager.
Details:
V1M2: 4.2.8.3
73. Additional Management System Requirements
The quality manual shall contain the objectives of the quality system and contain or reference the laboratory’s policies and procedures.
Details:
V1M2: 4.2.8.3
74. Additional Management System Requirements
The quality manual shall contain the laboratory’s official quality policy statement, which shall include quality system objectives and management’s commitment to ethical laboratory practices and to upholding the requirements of this Standard.
Details:
V1M2: 4.2.8.3
75. Additional Management System Requirements
The quality manual shall contain a table of contents, and applicable lists of references, glossaries and appendices.
Details:
V1M2: 4.2.8.3
76. Additional Management System Requirements
The quality manual shall contain or reference all maintenance, calibration and verification procedures used by the laboratory in conducting tests.
Details:
V1M2: 4.2.8.4
77. Additional Management System Requirements
The quality manual shall contain or reference major equipment and reference measurement standards used as well as the facilities and services used by the laboratory in conducting tests.
Details:
V1M2: 4.2.8.4
78. Additional Management System Requirements
The quality manual shall contain or reference verification practices, which may include inter-laboratory comparisons, proficiency testing programs, use of reference materials and internal quality control schemes.
Details:
V1M2: 4.2.8.4
79. Additional Management System Requirements
The quality manual shall contain or reference procedures for reporting analytical results.
Details:
V1M2: 4.2.8.4
80. Additional Management System Requirements
The quality manual shall contain or reference the organization and management structure of the laboratory, its place in any parent organization, and relevant organizational charts.
Details:
V1M2: 4.2.8.4
81. Additional Management System Requirements
The quality manual shall contain or reference procedures to ensure that all records required under this Standard are retained.
Details:
V1M2: 4.2.8.4
82. Additional Management System Requirements
The quality manual shall contain or reference procedures for control and maintenance of documentation through a document control system that ensures that all standard operating procedures (SOPs), manuals, or documents clearly indicate the time period during which the procedure or document was in force.
Details:
V1M2: 4.2.8.4
83. Additional Management System Requirements
The quality manual shall contain or reference job descriptions of key staff and reference to the job descriptions of other laboratory staff.
Details:
V1M2: 4.2.8.4
84. Additional Management System Requirements
The quality manual shall contain or reference procedures for achieving traceability of measurements.
Details:
V1M2: 4.2.8.4
85. Additional Management System Requirements
The quality manual shall contain or reference a list of all methods under which the laboratory performs its accredited testing.
Details:
V1M2: 4.2.8.4
86. Additional Management System Requirements
The quality manual shall contain or reference procedures for ensuring that the laboratory reviews all new work to ensure that it has the appropriate facilities and resources before commencing such work.
Details:
V1M2: 4.2.8.4
87. Additional Management System Requirements
The quality manual shall contain or reference procedures for handling samples.
Details:
V1M2: 4.2.8.4
88. Additional Management System Requirements
The quality manual shall contain or reference procedures to be followed for feedback and corrective action whenever testing discrepancies are detected, or departures from documented policies and procedures occur.
Details:
V1M2: 4.2.8.4
89. Additional Management System Requirements
The quality manual shall contain or reference policy for permitting departures from documented policies and procedures or from standard specifications.
Details:
V1M2: 4.2.8.4
90. Additional Management System Requirements
The quality manual shall contain or reference procedures for dealing with complaints.
Details:
V1M2: 4.2.8.4
91. Additional Management System Requirements
The quality manual shall contain or reference procedures for protecting confidentiality (including national security concerns), and proprietary rights.
Details:
V1M2: 4.2.8.4
92. Additional Management System Requirements
The quality manual shall contain or reference procedures for audits and data review.
Details:
V1M2: 4.2.8.4
93. Additional Management System Requirements
The quality manual shall contain or reference procedures for establishing that personnel are adequately experienced in the duties they are expected to carry out and are receiving any needed training.
Details:
V1M2: 4.2.8.4
94. Additional Management System Requirements
The quality manual shall contain or reference policy addressing the use of unique electronic signatures, where applicable.
Details:
V1M2: 4.2.8.4
95. Additional Management System Requirements
Laboratories shall maintain SOPs that accurately reflect all phases of current laboratory activities, such as assessing data integrity, corrective actions, handling customer complaints, and all methods.
Details:
V1M2: 4.2.8.5
96. Document Control
The laboratory shall establish and maintain procedures to control all documents that form part of its management system (internally generated or from external sources), such as regulations, standards, other normative documents, test and/or calibration methods, as well as drawings, software, specifications, instructions and manuals.
Details:
NOTE 1: In this context "document" could be policy statements, procedures, specifications, calibration tables, charts, text books, posters, notices, memoranda, software, drawings, plans, etc. These may be on various media, whether hard copy or electronic, and they may be digital, analog, photographic or written. NOTE 2: The control of data related to testing and calibration is covered in 5.4.7. The control of records is covered in 4.13. Additional Info: V1M2: 4.3.1
97. Recordkeeping
An environmental laboratory shall maintain records in an organized manner accessible by the Department.
Details:
252.706(a)
98. Recordkeeping
Records required under this chapter shall be maintained for a minimum of 5 years unless otherwise specified.
Details:
252.706(d)
99. Recordkeeping
An environmental laboratory shall have a written plan that specifies how records will be maintained or transferred if the laboratory transfers ownership or terminates operations.
Details:
252.706(e)
100. Document Approval and Issue
All documents issued to personnel in the laboratory as part of the management system shall be reviewed and approved for use by authorized personnel prior to issue.
Details:
V1M2: 4.3.2.1
101. Document Approval and Issue
A master list or an equivalent document control procedure identifying the current revision status and distribution of documents in the management system shall be established and shall be readily available to preclude the use of invalid and/or obsolete documents.
Details:
V1M2: 4.3.2.1
102. Document Approval and Issue
The document procedure(s) adopted shall ensure that authorized editions of appropriate documents are available at all locations where operations essential to the effective functioning of the laboratory are performed.
Details:
V1M2: 4.3.2.2
103. Document Approval and Issue
The document procedure(s) adopted shall ensure that documents are periodically reviewed and, where necessary, revised to ensure continuing suitability and compliance with applicable requirements.
Details:
V1M2: 4.3.2.2
104. Document Approval and Issue
The document procedure(s) adopted shall ensure that invalid or obsolete documents are promptly removed from all points of issue or use, or otherwise assured against unintended use.
Details:
V1M2: 4.3.2.2
105. Document Approval and Issue
The document procedure(s) adopted shall ensure that obsolete documents retained for either legal or knowledge preservation purposes are suitably marked.
Details:
V1M2: 4.3.2.2
106. Document Approval and Issue
Management system documents generated by the laboratory shall be uniquely identified.
Details:
V1M2: 4.3.2.3
107. Document Approval and Issue
[Management system document identification] shall include the date of issue and/or revision identification.
Details:
V1M2: 4.3.2.3
108. Document Approval and Issue
[Management system document identification] shall include page numbering.
Details:
V1M2: 4.3.2.3
109. Document Approval and Issue
[Management system document identification] shall include the total number of pages or a mark to signify the end of the document.
Details:
V1M2: 4.3.2.3
110. Document Approval and Issue
[Management system document identification] shall include the issuing authority(ies).
Details:
V1M2: 4.3.2.3
111. Document Changes
Changes to documents shall be reviewed and approved by the same function that performed the original review unless specifically designated otherwise.
Details:
V1M2: 4.3.3.1
112. Document Changes
The designated personnel shall have access to pertinent background information upon which to base their review and approval.
Details:
V1M2: 4.3.3.1
113. Document Changes
Where practicable, the altered or new text shall be identified in the document or the appropriate attachments.
Details:
V1M2: 4.3.3.2
114. Document Changes
If the laboratory's document control system allows for the amendment of documents by hand pending the re-issue of the documents, the procedures and authorities for such amendments shall be defined.
Details:
V1M2: 4.3.3.3
115. Document Changes
Amendments shall be clearly marked, initialled and dated.
Details:
V1M2: 4.3.3.3
116. Document Changes
A revised document shall be formally re-issued as soon as practicable.
Details:
V1M2: 4.3.3.3
117. Document Changes
Procedures shall be established to describe how changes in documents maintained in computerized systems are made and controlled.
Details:
V1M2: 4.3.3.4
118. Data Integrity Training
Data integrity training shall be provided as a formal part of new employee orientation and shall also be provided on an annual basis for all current employees.
Details:
V1M2: 5.2.7
119. Data Integrity Training
Employees are required to understand that any infractions of the laboratory data integrity procedures shall result in a detailed investigation that could lead to very serious consequences including immediate termination, debarment or civil/criminal prosecution.
Details:
V1M2: 5.2.7
120. Data Integrity Training
The initial data integrity training and the annual refresher training shall have a signature attendance sheet or other form of documentation that demonstrates all staff have participated and understand their obligations related to data integrity.
Details:
V1M2: 5.2.7
121. Data Integrity Training
Data integrity training requires emphasis on the importance of proper written narration on the part of the analyst with respect to those cases where analytical data may be useful, but are in one sense or another partially deficient
Details:
V1M2: 5.2.7
122. Data Integrity Training
The topics covered in such training shall be documented in writing (such as an agenda) and provided to all trainees.
Details:
V1M2: 5.2.7
123. Data Integrity Training
At a minimum, the following topics and activities shall be included: organizational mission and its relationship to the critical need for honesty and full disclosure in all analytical reporting, how and when to report data integrity issues, and record keeping.
Details:
The data integrity procedures may also include written ethics agreements, examples of improper practices, examples of improper chromatographic manipulations, requirements for external ethics program training, and any external resources available to employees. Additional Info: V1M2: 5.2.7
124. Data Integrity Training
At a minimum, the following topics and activities shall be included: training, including discussion regarding all data integrity procedures.
Details:
The data integrity procedures may also include written ethics agreements, examples of improper practices, examples of improper chromatographic manipulations, requirements for external ethics program training, and any external resources available to employees. Additional Info: V1M2: 5.2.7
125. Data Integrity Training
At a minimum, the following topics and activities shall be included: data integrity training documentation.
Details:
The data integrity procedures may also include written ethics agreements, examples of improper practices, examples of improper chromatographic manipulations, requirements for external ethics program training, and any external resources available to employees. Additional Info: V1M2: 5.2.7
126. Data Integrity Training
At a minimum, the following topics and activities shall be included: in-depth data monitoring and data integrity procedure documentation.
Details:
The data integrity procedures may also include written ethics agreements, examples of improper practices, examples of improper chromatographic manipulations, requirements for external ethics program training, and any external resources available to employees. Additional Info: V1M2: 5.2.7
127. Data Integrity Training
At a minimum, the following topics and activities shall be included: specific examples of breaches of ethical behavior such as improper data manipulations, adjustments of instrument time clocks, and inappropriate changes in concentrations of standards.
Details:
The data integrity procedures may also include written ethics agreements, examples of improper practices, examples of improper chromatographic manipulations, requirements for external ethics program training, and any external resources available to employees. Additional Info: V1M2: 5.2.7
128. Review of Requests, Tenders and Contracts
The policies and procedures for the review of requests, tenders and contracts leading to a contract for testing and/or calibration shall ensure that the requirements, including the methods to be used, are adequately defined, documented and understood (see 5.4.2).
Details:
V1M2: 4.4.1
129. Review of Requests, Tenders and Contracts
The policies and procedures for the review of requests, tenders and contracts leading to a contract for testing and/or calibration shall ensure that the laboratory has the capability and resources to meet the requirements.
Details:
V1M2: 4.4.1
130. Review of Requests, Tenders and Contracts
The policies and procedures for the review of requests, tenders and contracts leading to a contract for testing and/or calibration shall ensure that the appropriate test and/or calibration method is selected and is capable of meeting the customers' requirements (see 5.4.2).
Details:
V1M2: 4.4.1
131. Review of Requests, Tenders and Contracts
Any differences between the request or tender and the contract shall be resolved before any work commences. Each contract shall be acceptable both to the laboratory and the customer.
Details:
NOTE 1: The request, tender and contract review should be conducted in a practical and efficient manner, and the effect of financial, legal and time schedule aspects should be taken into account. For internal customers, reviews of requests, tenders and contracts can be performed in a simplified way. NOTE 2: The review of capability should establish that the laboratory possesses the necessary physical, personnel and information resources, and that the laboratory's personnel have the skills and expertise necessary for the performance of the tests and/or calibrations in question. The review may also encompass results of earlier participation in interlaboratory comparisons or proficiency testing and/or the running of trial test or calibration programmes using samples or items of known value in order to determine uncertainties of measurement, limits of detection, confidence limits, etc. NOTE 3: A contract may be any written or oral agreement to provide a customer with testing and/or calibration services. Additional Info: V1M2: 4.4.1
132. Review of Requests, Tenders and Contracts
Records of the review of requests, tenders and contracts, including any significant changes, shall be maintained.
Details:
V1M2: 4.4.2
133. Review of Requests, Tenders and Contracts
Records shall also be maintained of pertinent discussions with a customer relating to the customer's requirements or the results of the work during the period of execution of the contract.
Details:
NOTE: For review of routine and other simple tasks, the date and the identification (e.g. the initials) of the person in the laboratory responsible for carrying out the contracted work are considered adequate. For repetitive routine tasks, the review need be made only at the initial enquiry stage or on granting of the contract for on-going routine work performed under a general agreement with the customer, provided that the customer's requirements remain unchanged. For new, complex or advanced testing and/or calibration tasks, a more comprehensive record should be maintained. Additional Info: V1M2: 4.4.2
134. Review of Requests, Tenders and Contracts
The review of requests, tenders and contracts shall also cover any work that is subcontracted by the laboratory.
Details:
V1M2: 4.4.3
135. Review of Requests, Tenders and Contracts
The customer shall be informed of any deviation from the contract.
Details:
V1M2: 4.4.4
136. Review of Requests, Tenders and Contracts
If a contract needs to be amended after work has commenced, the same contract review process shall be repeated and any amendments shall be communicated to all affected personnel.
Details:
V1M2: 4.4.5
137. Subcontracting of Environmental Tests
When a laboratory subcontracts work, whether because of unforeseen reasons (e.g. workload, need for further expertise or temporary incapacity) or on a continuing basis (e.g. through permanent subcontracting, agency or franchising arrangements), this work shall be placed with a competent subcontractor. A competent subcontractor is one that, for example, complies with this International Standard for the work in question.
Details:
V1M2: 4.5.1
138. Subcontracting of Environmental Tests
The laboratory shall advise the customer of the arrangement in writing and, when appropriate, gain the approval of the customer, preferably in writing.
Details:
V1M2: 4.5.2
139. Subcontracting of Environmental Tests
The laboratory is responsible to the customer for the subcontractor's work, except in the case where the customer or a regulatory authority specifies which subcontractor is to be used.
Details:
V1M2: 4.5.3
140. Subcontracting of Environmental Tests
The laboratory shall maintain a register of all subcontractors that it uses for tests and/or calibrations and a record of the evidence of compliance with this International Standard for the work in question.
Details:
V1M2: 4.5.4
141. Subcontracting of Environmental Tests
When a laboratory subcontracts work, this work shall be placed with a laboratory accredited to this Standard for the tests to be performed or with a laboratory that meets applicable statutory and regulatory requirements for performing the tests and submitting the results of tests performed.
Details:
V1M2: 4.5.5
142. Subcontracting of Environmental Tests
The laboratory performing the subcontracted work shall be indicated in the final report.
Details:
V1M2: 4.5.5
143. Subcontracting of Environmental Tests
The laboratory shall make a copy of the subcontractor’s report available to the client when requested.
Details:
V1M2: 4.5.5
144. Subcontracting
An environmental laboratory may not subcontract testing or analysis covered under this chapter to an environmental laboratory that is not accredited and in compliance with this chapter.
Details:
252.707(a)
145. Purchasing Services and Supplies
The laboratory shall have a policy and procedure(s) for the selection and purchasing of services and supplies it uses that affect the quality of the tests and/or calibrations.
Details:
V1M2: 4.6.1
146. Purchasing Services and Supplies
Procedures shall exist for the purchase, reception and storage of reagents and laboratory consumable materials relevant for the tests and calibrations.
Details:
V1M2: 4.6.1
147. Purchasing Services and Supplies
The laboratory shall ensure that purchased supplies and reagents and consumable materials that affect the quality of tests and/or calibrations are not used until they have been inspected or otherwise verified as complying with standard specifications or requirements defined in the methods for the tests and/or calibrations concerned.
Details:
V1M2: 4.6.2
148. Purchasing Services and Supplies
These services and supplies used shall comply with specified requirements.
Details:
V1M2: 4.6.2
149. Purchasing Services and Supplies
Records of actions taken to check compliance of services and supplies shall be maintained.
Details:
V1M2: 4.6.2
150. Purchasing Services and Supplies
Purchasing documents for items affecting the quality of laboratory output shall contain data describing the services and supplies ordered.
Details:
V1M2: 4.6.3
151. Purchasing Services and Supplies
These purchasing documents shall be reviewed and approved for technical content prior to release.
Details:
NOTE: The description may include type, class, grade, precise identification, specifications, drawings, inspection instructions, other technical data including approval of test results, the quality required and the management system standard under which they were made. Additional Info: V1M2: 4.6.3
152. Purchasing Services and Supplies
The laboratory shall evaluate suppliers of critical consumables, supplies and services which affect the quality of testing and calibration,
Details:
V1M2: 4.6.4
153. Purchasing Services and Supplies
The laboratory shall maintain records of the evaluation suppliers of critical consumables, supplies and services and list those approved.
Details:
V1M2: 4.6.4
154. Service to the Client
The laboratory shall be willing to cooperate with customers or their representatives in clarifying the customer's request and in monitoring the laboratory's performance in relation to the work performed, provided that the laboratory ensures confidentiality to other customers.
Details:
NOTE 1: Such cooperation may include: a) providing the customer or the customer's representative reasonable access to relevant areas of the laboratory for the witnessing of tests and/or calibrations performed for the customer; b) preparation, packaging, and dispatch of test and/or calibration items needed by the customer for verification purposes. NOTE 2: Customers value the maintenance of good communication, advice and guidance in technical matters, and opinions and interpretations based on results. Communication with the customer, especially in large assignments, should be maintained throughout the work. The laboratory should inform the customer of any delays or major deviations in the performance of the tests and/or calibrations. Additional Info: V1M2: 4.7.1
155. Service to the Client
The laboratory shall seek feedback, both positive and negative, from its customers.
Details:
V1M2: 4.7.2
156. Service to the Client
The feedback shall be used and analyzed to improve the management system, testing and calibration activities and customer service.
Details:
NOTE: Examples of the types of feedback include customer satisfaction surveys and review of test or calibration reports with customers. Additional Info: V1M2: 4.7.2
157. Complaints
The laboratory shall have a policy and procedure for the resolution of complaints received from customers or other parties.
Details:
V1M2: 4.8
158. Complaints
Records shall be maintained of all complaints and of the investigations and corrective actions taken by the laboratory (see also 4.11).
Details:
V1M2: 4.8
159. Control of Nonconforming Environmental Testing Work
The laboratory shall have a policy and procedures that shall be implemented when any aspect of its testing and/or calibration work, or the results of this work, do not conform to its own procedures or the agreed requirements of the customer.
Details:
V1M2: 4.9.1
160. Control of Nonconforming Environmental Testing Work
The policy and procedures shall ensure that the responsibilities and authorities for the management of nonconforming work are designated and actions (including halting of work and withholding of test reports and calibration certificates, as necessary) are defined and taken when nonconforming work is identified.
Details:
NOTE: Identification of nonconforming work or problems with the management system or with testing and/or calibration activities can occur at various places within the management system and technical operations. Examples are customer complaints, quality control, instrument calibration, checking of consumable materials, staff observations or supervision, test report and calibration certificate checking, management reviews and internal or external audits. Additional Info: V1M2: 4.9.1
161. Control of Nonconforming Environmental Testing Work
The policy and procedures shall ensure that an evaluation of the significance of the nonconforming work is made.
Details:
NOTE: Identification of nonconforming work or problems with the management system or with testing and/or calibration activities can occur at various places within the management system and technical operations. Examples are customer complaints, quality control, instrument calibration, checking of consumable materials, staff observations or supervision, test report and calibration certificate checking, management reviews and internal or external audits. Additional Info: V1M2: 4.9.1
162. Control of Nonconforming Environmental Testing Work
The policy and procedures shall ensure that correction is taken immediately, together with any decision about the acceptability of the nonconforming work.
Details:
NOTE: Identification of nonconforming work or problems with the management system or with testing and/or calibration activities can occur at various places within the management system and technical operations. Examples are customer complaints, quality control, instrument calibration, checking of consumable materials, staff observations or supervision, test report and calibration certificate checking, management reviews and internal or external audits. Additional Info: V1M2: 4.9.1
163. Control of Nonconforming Environmental Testing Work
The policy and procedures shall ensure that where necessary, the customer is notified and work is recalled.
Details:
NOTE: Identification of nonconforming work or problems with the management system or with testing and/or calibration activities can occur at various places within the management system and technical operations. Examples are customer complaints, quality control, instrument calibration, checking of consumable materials, staff observations or supervision, test report and calibration certificate checking, management reviews and internal or external audits. Additional Info: V1M2: 4.9.1
164. Control of Nonconforming Environmental Testing Work
The policy and procedures shall ensure that the responsibility for authorizing the resumption of work is defined.
Details:
NOTE: Identification of nonconforming work or problems with the management system or with testing and/or calibration activities can occur at various places within the management system and technical operations. Examples are customer complaints, quality control, instrument calibration, checking of consumable materials, staff observations or supervision, test report and calibration certificate checking, management reviews and internal or external audits. Additional Info: V1M2: 4.9.1
165. Control of Nonconforming Environmental Testing Work
Where the evaluation indicates that the nonconforming work could recur or that there is doubt about the compliance of the laboratory's operations with its own policies and procedures, the corrective action procedures given in 4.11 shall be promptly followed.
Details:
V1M2: 4.9.2
166. Improvement
The laboratory shall continually improve the effectiveness of its management system through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions and management review.
Details:
V1M2: 4.10
167. Corrective Action
The laboratory shall establish a policy and a procedure for implementing corrective action when nonconforming work or departures from the policies and procedures in the management system or technical operations have been identified.
Details:
V1M2: 4.11.1
168. Corrective Action
The laboratory shall designate appropriate authorities for implementing corrective action when nonconforming work or departures from the policies and procedures in the management system or technical operations have been identified.
Details:
NOTE: A problem with the management system or with the technical operations of the laboratory may be identified through a variety of activities, such as control of nonconforming work, internal or external audits, management reviews, feedback from customers and from staff observations. Additional Info: V1M2: 4.11.1
169. Cause Analysis
The procedure for corrective action shall start with an investigation to determine the root cause(s) of the problem.
Details:
NOTE: Cause analysis is the key and sometimes the most difficult part in the corrective action procedure. Often the root cause is not obvious and thus a careful analysis of all potential causes of the problem is required. Potential causes could include customer requirements, the samples, sample specifications, methods and procedures, staff skills and training, consumables, or equipment and its calibration. Additional Info: V1M2: 4.11.2
170. Selection and Implementation of Corrective Actions
Where corrective action is needed, the laboratory shall identify potential corrective actions.
Details:
V1M2: 4.11.3
171. Selection and Implementation of Corrective Actions
It shall select and implement the action(s) most likely to eliminate the problem and to prevent recurrence.
Details:
V1M2: 4.11.3
172. Selection and Implementation of Corrective Actions
Corrective actions shall be to a degree appropriate to the magnitude and the risk of the problem.
Details:
V1M2: 4.11.3
173. Selection and Implementation of Corrective Actions
The laboratory shall document and implement any required changes resulting from corrective action investigations.
Details:
V1M2: 4.11.3
174. Monitoring of Corrective Actions
The laboratory shall monitor the results to ensure that the corrective actions taken have been effective.
Details:
V1M2: 4.11.4
175. Additional Audits
Where the identification of nonconformities or departures casts doubts on the laboratory's compliance with its own policies and procedures, or on its compliance with this International Standard, the laboratory shall ensure that the appropriate areas of activity are audited in accordance with 4.14 as soon as possible.
Details:
NOTE: Such additional audits often follow the implementation of the corrective actions to confirm their effectiveness. An additional audit should be necessary only when a serious issue or risk to the business is identified. Additional Info: V1M2: 4.11.5
176. Additional Audits
The laboratory shall have documented procedure(s) to address: Section 4.11.1 (Designation of appropriate authorities for implementing corrective actions, departures from policies and procedures)
Details:
V1M2: 4.11.6
177. Additional Audits
The laboratory shall have documented procedure(s) to address: Section 4.11.3 (Selection and Implementation of Corrective Actions)
Details:
V1M2: 4.11.6
178. Additional Audits
The laboratory shall have documented procedure(s) to address: Section 4.11.4 (Monitoring of Corrective Actions)
Details:
V1M2: 4.11.6
179. Additional Audits
The laboratory shall have documented procedure(s) to address: Section 4.11.5 (Additional Audits)
Details:
V1M2: 4.11.6
180. Additional Audits
These procedure(s) shall also include: which individual(s) or positions are responsible for assessing each QC data type; and
Details:
V1M2: 4.11.6.a
181. Additional Audits
These procedure(s) shall also include: which individual(s) or positions are responsible for initiating and/or recommending corrective actions.
Details:
V1M2: 4.11.6.b
182. Preventive Action
Needed improvements and potential sources of nonconformities, either technical or concerning the management system, shall be identified.
Details:
V1M2: 4.12.1
183. Preventive Action
When improvement opportunities are identified or if preventive action is required, action plans shall be developed, implemented and monitored to reduce the likelihood of the occurrence of such nonconformities and to take advantage of the opportunities for improvement.
Details:
V1M2: 4.12.1
184. Preventive Action
Procedures for preventive actions shall include the initiation of such actions and the application of controls to ensure that they are effective.
Details:
NOTE 1: Preventive action is a pro-active process to identify opportunities for improvement rather than a reaction to the identification of problems or complaints. NOTE 2: Apart from the review of the operational procedures, the preventive action might involve analysis of data, including trend and risk analyses and proficiency-testing results. Additional Info: V1M2: 4.12.2
185. Control of Records
The laboratory shall establish and maintain procedures for identification, collection, indexing, access, filing, storage, maintenance and disposal of quality and technical records.
Details:
V1M2: 4.13.1.1
186. Control of Records
Quality records shall include reports from internal audits and management reviews as well as records of corrective and preventive actions.
Details:
V1M2: 4.13.1.1
187. Control of Records
All records shall be legible and shall be stored and retained in such a way that they are readily retrievable in facilities that provide a suitable environment to prevent damage or deterioration and to prevent loss.
Details:
V1M2: 4.13.1.2
188. Control of Records
Retention times of records shall be established.
Details:
NOTE: Records may be in any media, such as hard copy or electronic media. Additional Info: V1M2: 4.13.1.2
189. Control of Records
All records shall be held secure and in confidence.
190. Control of Records
All records shall be held secure and in confidence.
Details:
V1M2: 4.13.1.3
191. Control of Records
The laboratory shall have procedures to protect and back-up records stored electronically.
Details:
V1M2: 4.13.1.4
192. Control of Records
The laboratory shall have procedures to prevent unauthorized access to or amendment of these records.
Details:
V1M2: 4.13.1.4
193. Internal Audits
The laboratory shall periodically, and in accordance with a predetermined schedule and procedure, conduct internal audits of its activities to verify that its operations continue to comply with the requirements of the management system and this International Standard.
Details:
V1M2: 4.14.1
194. Internal Audits
The internal audit programme shall address all elements of the management system, including the testing and/or calibration activities.
Details:
V1M2: 4.14.1
195. Internal Audits
It is the responsibility of the quality manager to plan and organize audits as required by the schedule and requested by management.
Details:
V1M2: 4.14.1
196. Internal Audits
Such audits shall be carried out by trained and qualified personnel who are, wherever resources permit, independent of the activity to be audited.
Details:
NOTE: The cycle for internal auditing should normally be completed in one year. Additional Info: V1M2: 4.14.1
197. Internal Audits
When audit findings cast doubt on the effectiveness of the operations or on the correctness or validity of the laboratory's test or calibration results, the laboratory shall take timely corrective action.
Details:
V1M2: 4.14.2
198. Internal Audits
When audit findings cast doubt on the effectiveness of the operations or on the correctness or validity of the laboratory's test or calibration results, the laboratory shall notify customers in writing if investigations show that the laboratory results may have been affected.
Details:
V1M2: 4.14.2
199. Internal Audits
The area of activity audited, the audit findings and corrective actions that arise from them shall be recorded.
Details:
V1M2: 4.14.3
200. Internal Audits
Follow-up audit activities shall verify and record the implementation and effectiveness of the corrective action taken.
Details:
V1M2: 4.14.4
201. Internal Audits
The laboratory shall have a policy that specifies the time frame for notifying a client of events that cast doubt on the validity of the results.
Details:
V1M2: 4.14.5.a
202. Internal Audits
The laboratory management shall ensure that these actions are discharged within the agreed time frame.
Details:
V1M2: 4.14.5.b
203. Internal Audits
The Internal audit schedule shall be completed annually,
Details:
V1M2: 4.14.5.c
204. Management Reviews
In accordance with a predetermined schedule and procedure, the laboratory's top management shall periodically conduct a review of the laboratory's management system and testing and/or calibration activities to ensure their continuing suitability and effectiveness.
Details:
V1M2: 4.15.1
205. Management Reviews
In accordance with a predetermined schedule and procedure, the laboratory's top management shall periodically conduct a review of the laboratory's management system and testing and/or calibration activities to introduce necessary changes or improvements.
Details:
V1M2: 4.15.1
206. Management Reviews
The management review shall take account of the suitability of policies and procedures.
Details:
V1M2: 4.15.1
207. Management Reviews
The management review shall take account of reports from managerial and supervisory personnel.
Details:
V1M2: 4.15.1
208. Management Reviews
The management review shall take account of the outcome of recent internal audits.
Details:
V1M2: 4.15.1
209. Management Reviews
The management review shall take account of corrective and preventive actions.
Details:
V1M2: 4.15.1
210. Management Reviews
The management review shall take account of assessments by external bodies.
Details:
V1M2: 4.15.1
211. Management Reviews
The management review shall take account of the results of interlaboratory comparisons or proficiency tests.
Details:
V1M2: 4.15.1
212. Management Reviews
The management review shall take account of changes in the volume and type of the work.
Details:
V1M2: 4.15.1
213. Management Reviews
The management review shall take account of customer feedback.
Details:
V1M2: 4.15.1
214. Management Reviews
The management review shall take account of complaints.
Details:
V1M2: 4.15.1
215. Management Reviews
The management review shall take account of recommendations for improvement.
Details:
V1M2: 4.15.1
216. Management Reviews
The management review shall take account of other relevant factors, such as quality control activities, resources, and staff training.
Details:
NOTE 1: A typical period for conducting a management review is once every 12 months. NOTE 2: Results should feed into the laboratory planning system and should include the goals, objectives and action plans for the coming year. NOTE 3: A management review includes consideration of related subjects at regular management meetings. Additional Info: V1M2: 4.15.1
217. Management Reviews
Findings from management reviews and the actions that arise from them shall be recorded.
Details:
V1M2: 4.15.2
218. Management Reviews
The management shall ensure that those actions are carried out within an appropriate and agreed timescale.
Details:
V1M2: 4.15.2
219. Management Reviews
Management review shall be completed on an annual basis.
Details:
V1M2: 4.15.3
220. Data Integrity Investigations
All investigations resulting from data integrity issues should be conducted in a confidential manner until they are completed.
Details:
V1M2: 4.16
221. Data Integrity Investigations
These investigations shall be documented, as well as any notifications made to clients receiving any affected data.
Details:
V1M2: 4.16
222. Collection of Samples
The laboratory shall have a sampling plan and procedures for sampling when it carries out sampling of substances, materials or products for subsequent testing or calibration.
Details:
V1M2: 5.7.1
223. Collection of Samples
The sampling plan as well as the sampling procedure shall be available at the location where sampling is undertaken.
Details:
V1M2: 5.7.1
224. Collection of Samples
Sampling plans shall, whenever reasonable, be based on appropriate statistical methods.
Details:
V1M2: 5.7.1
225. Collection of Samples
The sampling process shall address the factors to be controlled to ensure the validity of the test and calibration results.
Details:
NOTE 1: Sampling is a defined procedure whereby a part of a substance, material or product is taken to provide for testing or calibration of a representative sample of the whole. Sampling may also be required by the appropriate specification for which the substance, material or product is to be tested or calibrated. In certain cases (e.g. forensic analysis), the sample may not be representative but is determined by availability. NOTE 2: Sampling procedures should describe the selection, sampling plan, withdrawal and preparation of a sample or samples from a substance, material or product to yield the required information. Additional Info: V1M2: 5.7.1
226. Collection of Samples
Where the customer requires deviations, additions or exclusions from the documented sampling procedure, these shall be recorded in detail with the appropriate sampling data .
Details:
V1M2: 5.7.2
227. Collection of Samples
Where the customer requires deviations, additions or exclusions from the documented sampling procedure, these shall be included in all documents containing test and/or calibration results.
Details:
V1M2: 5.7.2
228. Collection of Samples
Where the customer requires deviations, additions or exclusions from the documented sampling procedure, these shall be communicated to the appropriate personnel.
Details:
V1M2: 5.7.2
229. Collection of Samples
The laboratory shall have procedures for recording relevant data and operations relating to sampling that forms part of the testing or calibration that is undertaken.
Details:
V1M2: 5.7.3
230. Collection of Samples
These records shall include the sampling procedure used, the identification of the sampler, environmental conditions (if relevant) and diagrams or other equivalent means to identify the sampling location as necessary and, if appropriate, the statistics the sampling procedures are based upon.
Details:
V1M2: 5.7.3
231. Collection of Samples
Documentation shall include the date and time of sampling.
Details:
V1M2: 5.7.4.a
232. Collection of Samples
Any deviations from sampling procedures shall be documented.
Details:
V1M2: 5.7.4.b
233. Handling Samples and Test Items
The laboratory shall have procedures for the transportation, receipt, handling, protection, storage, retention and/or disposal of test and/or calibration items, including all provisions necessary to protect the integrity of the test or calibration item, and to protect the interests of the laboratory and the customer.
Details:
V1M2: 5.8.1
234. Handling Samples and Test Items
The laboratory shall have a system for identifying test and/or calibration items.
Details:
V1M2: 5.8.2
235. Handling Samples and Test Items
The identification shall be retained throughout the life of the item in the laboratory.
Details:
V1M2: 5.8.2
236. Handling Samples and Test Items
The system shall be designed and operated so as to ensure that items cannot be confused physically or when referred to in records or other documents.
Details:
V1M2: 5.8.2
237. Handling Samples and Test Items
The system shall, if appropriate, accommodate a sub-division of groups of items and the transfer of items within and from the laboratory.
Details:
V1M2: 5.8.2
238. Handling Samples and Test Items
Upon receipt of the test or calibration item, abnormalities or departures from normal or specified conditions, as described in the test or calibration method, shall be recorded.
Details:
V1M2: 5.8.3
239. Handling Samples and Test Items
When there is doubt as to the suitability of an item for test or calibration, or when an item does not conform to the description provided, or the test or calibration required is not specified in sufficient detail, the laboratory shall consult the customer for further instructions before proceeding and shall record the discussion.
Details:
V1M2: 5.8.3
240. Handling Samples and Test Items
The laboratory shall have procedures and appropriate facilities for avoiding deterioration, loss or damage to the test or calibration item during storage, handling and preparation.
Details:
V1M2: 5.8.4
241. Handling Samples and Test Items
Handling instructions provided with the item shall be followed.
Details:
V1M2: 5.8.4
242. Handling Samples and Test Items
When items have to be stored or conditioned under specified environmental conditions, these conditions shall be maintained, monitored and recorded.
Details:
V1M2: 5.8.4
243. Handling Samples and Test Items
Where a test or calibration item or a portion of an item is to be held secure, the laboratory shall have arrangements for storage and security that protect the condition and integrity of the secured items or portions concerned.
Details:
NOTE 1: Where test items are to be returned into service after testing, special care is required to ensure that they are not damaged or injured during the handling, testing or storing/waiting processes. NOTE 2: A sampling procedure and information on storage and transport of samples, including information on sampling factors influencing the test or calibration result, should be provided to those responsible for taking and transporting the samples. NOTE 3: Reasons for keeping a test or calibration item secure can be for reasons of record, safety or value, or to enable complementary tests and/or calibrations to be performed later. Additional Info: V1M2: 5.8.4
244. Additional Requirements - Documentation
The laboratory shall have a documented system for uniquely identifying the samples to be tested, to ensure that there can be no confusion regarding the identity of such samples at any time.
Details:
The following are essential to ensure the validity of the laboratory’s data. Additional Info: V1M2: 5.8.5.a
245. Additional Requirements - Documentation
This system shall include identification for all samples, sub-samples, preservations, sample containers, tests, and subsequent extracts and/or digestates.
Details:
The following are essential to ensure the validity of the laboratory’s data. Additional Info: V1M2: 5.8.5.a
246. Additional Requirements - Documentation
This laboratory code shall maintain an unequivocal link with the unique field ID code assigned to each sample.
Details:
The following are essential to ensure the validity of the laboratory’s data. Additional Info: V1M2: 5.8.5.b
247. Additional Requirements - Documentation
The laboratory ID code shall be placed as a durable mark on the sample container.
Details:
The following are essential to ensure the validity of the laboratory’s data. Additional Info: V1M2: 5.8.5.c
248. Additional Requirements - Documentation
The laboratory ID code shall be entered into the laboratory records.
Details:
The following are essential to ensure the validity of the laboratory’s data. Additional Info: V1M2: 5.8.5.d
249. Additional Requirements - Documentation
The laboratory ID code shall be the link that associates the sample with related laboratory activities such as sample preparation.
Details:
The following are essential to ensure the validity of the laboratory’s data. Additional Info: V1M2: 5.8.5.d
250. Additional Requirements - Documentation
In cases where the sample collector and analyst are the same individual, or the laboratory pre-assigns numbers to sample containers, the laboratory ID code may be the same as the field ID code.
Details:
The following are essential to ensure the validity of the laboratory’s data. Additional Info: V1M2: 5.8.5.e
251. Additional Requirements - Sample Acceptance Policy
The laboratory shall have a written sample acceptance policy that includes proper, full, and complete documentation, which shall include: --Sample Identification --Location --Date and Time of Collection --Collector's Name --Preservation Type --Sample Type --Any special remarks concerning the sample
Details:
V1M2: 5.8.6
252. Additional Requirements - Sample Acceptance Policy
The laboratory shall have a written sample acceptance policy that includes proper sample labeling to include: --Unique Identification --A labeling system for the sample with requirements concerning the durability of labels (water resistant) and the use of indelible ink
Details:
V1M2: 5.8.6
253. Additional Requirements - Sample Acceptance Policy
The laboratory shall have a written sample acceptance policy that includes the use of appropriate sample containers.
Details:
V1M2: 5.8.6
254. Additional Requirements - Sample Acceptance Policy
The laboratory shall have a written sample acceptance policy that includes adherence to specified holding times.
Details:
V1M2: 5.8.6
255. Additional Requirements - Sample Acceptance Policy
The laboratory shall have a written sample acceptance policy that includes sufficient sample volume to perform the necessary tests.
Details:
V1M2: 5.8.6
256. Additional Requirements - Sample Acceptance Policy
The laboratory shall have a written sample acceptance policy that includes procedures to be used when samples show signs of damage, contamination or inadequate preservation.
Details:
V1M2: 5.8.6
257. Additional Requirements - Sample Acceptance Policy
The laboratory shall have a written sample acceptance policy that includes qualification of any data that do not meet the above requirements.
Details:
V1M2: 5.8.6
258. Additional Requirements - Sample Receipt Protocols
The laboratory shall implement procedures for verifying and documenting preservation.
Details:
V1M2: 5.8.7.1
259. Additional Requirements - Sample Receipt Protocols
If the sample does not meet the sample receipt acceptance criteria listed in this Standard, the laboratory shall either: - retain correspondence and/or records of conversations concerning the final disposition of rejected samples; or - fully document any decision to proceed with the analysis of samples not meeting acceptance criteria.
Details:
i) The condition of these samples shall be noted on the chain of custody or transmittal form and laboratory receipt documents. ii) The analysis data shall be appropriately qualified on the final report. Additional Info: V1M2: 5.8.7.2
260. Additional Requirements - Sample Receipt Protocols
The laboratory shall utilize a permanent chronological record such as a logbook or electronic database to document receipt of all sample containers.
Details:
V1M2: 5.8.7.3
261. Additional Requirements - Sample Receipt Protocols
This sample receipt log shall record client/project name.
Details:
V1M2: 5.8.7.3.a
262. Additional Requirements - Sample Receipt Protocols
This sample receipt log shall record date and time of laboratory receipt.
Details:
V1M2: 5.8.7.3.a
263. Additional Requirements - Sample Receipt Protocols
This sample receipt log shall record unique laboratory ID code.
Details:
V1M2: 5.8.7.3.a
264. Additional Requirements - Sample Receipt Protocols
This sample receipt log shall record signature or initials of the person making the entries.
Details:
V1M2: 5.8.7.3.a
265. Additional Requirements - Sample Receipt Protocols
During the login process, the following information shall be unequivocally linked to the log record or included as a part of the log.
Details:
V1M2: 5.8.7.3.b
266. Organization
It is the responsibility of the laboratory to carry out its testing and calibration activities in such a way as to meet the requirements of this International Standard.
Details:
V1M2: 4.1.2
267. Additional Requirements - Sample Receipt Protocols
The date and time of sample collection shall be linked to the sample and to the date and time of receipt in the laboratory.
Details:
If such information is recorded/documented elsewhere, the records shall be part of the laboratory's permanent records, easily retrievable upon request and readily available to individuals who will process the sample. Additional Info: V1M2: 5.8.7.3.b
268. Additional Requirements - Sample Receipt Protocols
The requested analyses (including applicable approved method numbers) shall be linked to the laboratory ID code.
Details:
If such information is recorded/documented elsewhere, the records shall be part of the laboratory's permanent records, easily retrievable upon request and readily available to individuals who will process the sample. Additional Info: V1M2: 5.8.7.3.b
269. Additional Requirements - Sample Receipt Protocols
Any comments resulting from inspection for sample rejection shall be linked to the laboratory ID code.
Details:
NOTE: The placement of the laboratory ID number on the sample container is not considered a permanent record. If such information is recorded/documented elsewhere, the records shall be part of the laboratory's permanent records, easily retrievable upon request and readily available to individuals who will process the sample. Additional Info: V1M2: 5.8.7.3.b
270. Additional Requirements - Sample Receipt Protocols
Any comments resulting from inspection for sample rejection shall be linked to the laboratory ID code.
Details:
NOTE: The placement of the laboratory ID number on the sample container is not considered a permanent record. If such information is recorded/documented elsewhere, the records shall be part of the laboratory's permanent records, easily retrievable upon request and readily available to individuals who will process the sample. Additional Info: V1M2: 5.8.7.3.b
271. Additional Requirements - Sample Receipt Protocols
All documentation, such as memos, chain of custody, or transmittal forms that are transmitted to the laboratory by the sample transmitter, shall be retained.
Details:
V1M2: 5.8.7.4
272. Additional Requirements - Sample Receipt Protocols
All documentation, such as memos, chain of custody, or transmittal forms that are transmitted to the laboratory by the sample transmitter, shall be retained.
Details:
V1M2: 5.8.7.4
273. Additional Requirements - Sample Receipt Protocols
A complete chain of custody record form, if utilized, shall be maintained.
Details:
V1M2: 5.8.7.5
274. Additional Requirements - Legal Chain of Custody Protocols
If a client specifies that a sample is to be used for evidentiary purposes, then a laboratory shall have a written SOP for how that laboratory will carry out legal chain of custody.
Details:
Legal chain of custody procedures are used for evidentiary or legal purposes. Additional Info: V1M2: 5.8.8
275. Reporting the Results- General
The results of each test, calibration, or series of tests or calibrations carried out by the laboratory shall be reported accurately, clearly, unambiguously and objectively, and in accordance with any specific instructions in the test or calibration methods.
Details:
NOTE: All references to Calibration Certificates in ISO/IEC 17025:2005 are not applicable to environmental testing. Additional Info: V1M2: 5.10.1
276. Reporting the Results- General
The results shall be reported, usually in a test report or a calibration certificate (see Note 1), and shall include all the information requested by the customer and necessary for the interpretation of the test or calibration results and all information required by the method used. This information is normally that required by 5.10.2, and 5.10.3 or 5.10.4.
Details:
NOTE: All references to Calibration Certificates in ISO/IEC 17025:2005 are not applicable to environmental testing. Additional Info: V1M2: 5.10.1
277. Reporting the Results- General
In the case of tests or calibrations performed for internal customers, or in the case of a written agreement with the customer, the results may be reported in a simplified way.
Details:
NOTE: All references to Calibration Certificates in ISO/IEC 17025:2005 are not applicable to environmental testing. Additional Info: V1M2: 5.10.1
278. Reporting the Results- General
Any information listed in 5.10.2 to 5.10.4 which is not reported to the customer shall be readily available in the laboratory which carried out the tests and/or calibrations.
Details:
NOTE: All references to Calibration Certificates in ISO/IEC 17025:2005 are not applicable to environmental testing. NOTE 1: Test reports and calibration certificates are sometimes called test certificates and calibration reports respectively. NOTE 2: The test reports or calibration certificates may be issued as hard copy or by electronic data transfer provided that the requirements of this International Standard are met. Additional Info: V1M2: 5.10.1
279. Test Reports and Calibration Certificates
Each test report or calibration certificate shall include at least the following information, unless the laboratory has valid reasons for not doing so: a title (e.g. "Test Report" or "Calibration Certificate").
Details:
V1M2: 5.10.2
280. Test Reports and Calibration Certificates
Each test report or calibration certificate shall include at least the following information, unless the laboratory has valid reasons for not doing so: the name and address of the laboratory, and the location where the tests and/or calibrations were carried out, if different from the address of the laboratory.
Details:
V1M2: 5.10.2
281. Test Reports and Calibration Certificates
Each test report or calibration certificate shall include at least the following information, unless the laboratory has valid reasons for not doing so: unique identification of the test report or calibration certificate (such as the serial number), and on each page an identification in order to ensure that the page is recognized as a part of the test report or calibration certificate, and a clear identification of the end of the test report or calibration certificate.
Details:
V1M2: 5.10.2
282. Test Reports and Calibration Certificates
Each test report or calibration certificate shall include at least the following information, unless the laboratory has valid reasons for not doing so: the name and address of the customer.
Details:
V1M2: 5.10.2
283. Test Reports and Calibration Certificates
Each test report or calibration certificate shall include at least the following information, unless the laboratory has valid reasons for not doing so: identification of the method used.
Details:
V1M2: 5.10.2
284. Test Reports and Calibration Certificates
Each test report or calibration certificate shall include at least the following information, unless the laboratory has valid reasons for not doing so: a description of, the condition of, and unambiguous identification of the item(s) tested or calibrated.
Details:
V1M2: 5.10.2
285. Test Reports and Calibration Certificates
Each test report or calibration certificate shall include at least the following information, unless the laboratory has valid reasons for not doing so: the date of receipt of the test or calibration item(s) where this is critical to the validity and application of the results, and the date(s) of performance of the test or calibration.
Details:
V1M2: 5.10.2
286. Test Reports and Calibration Certificates
Each test report or calibration certificate shall include at least the following information, unless the laboratory has valid reasons for not doing so: reference to the sampling plan and procedures used by the laboratory or other bodies where these are relevant to the validity or application of the results.
Details:
V1M2: 5.10.2
287. Test Reports and Calibration Certificates
Each test report or calibration certificate shall include at least the following information, unless the laboratory has valid reasons for not doing so: the name(s), function(s) and signature(s) or equivalent identification of person(s) authorizing the test report or calibration certificate.
Details:
V1M2: 5.10.2
288. Test Reports and Calibration Certificates
Each test report or calibration certificate shall include at least the following information, unless the laboratory has valid reasons for not doing so: where relevant, a statement to the effect that the results relate only to the items tested or calibrated.
Details:
V1M2: 5.10.2
289. Additional Requirements
Time of sample preparation and/or analysis if the required holding time for either activity is less than or equal to seventy-two hours.
Details:
V1M2: 5.10.11
290. Additional Requirements
Results that are reported on a basis other than as received (e. g., dry weight).
Details:
V1M2: 5.10.11
291. Additional Requirements
Any non-accredited tests shall be clearly identified as such to the client when claims of accreditation to this Standard are made in the analytical report or in the supporting electronic or hardcopy deliverables.
Details:
V1M2: 5.10.11
292. Additional Requirements
Clear identification of numerical results with values outside the calibration range.
Details:
V1M2: 5.10.11
293. Use of Accreditation
Environmental laboratories using the Department's name, making reference to its accreditation status or using the Department's logo in catalogs, advertising, business solicitations, proposals, quotations, laboratory analytical reports or other materials shall distinguish between testing for which the laboratory is accredited and testing for which the laboratory is not accredited.
Details:
NOTE 1: Hard copies of test reports and calibration certificates should also include the page number and total number of pages. NOTE 2: It is recommended that laboratories include a statement specifying that the test report or calibration certificate shall not be reproduced except in full, without written approval of the laboratory. Additional Info: 252.705(b)
294. Use of Accreditation
Environmental laboratories using the Department's name, making reference to its accreditation status or using the Department's logo in catalogs, advertising, business solicitations, proposals, quotations, laboratory analytical reports or other materials shall include the environmental laboratory’s PA-DEP assigned accreditation number.
Details:
NOTE 1: Hard copies of test reports and calibration certificates should also include the page number and total number of pages. NOTE 2: It is recommended that laboratories include a statement specifying that the test report or calibration certificate shall not be reproduced except in full, without written approval of the laboratory. Additional Info: 252.705(b)
295. Test Reports
In addition to the requirements listed in 5.10.2, test reports shall, where necessary for the interpretation of the test results, include deviations from, additions to, or exclusions from the test method, and information on specific test conditions, such as environmental conditions.
Details:
V1M2: 5.10.3.1
296. Test Reports
In addition to the requirements listed in 5.10.2, test reports shall, where necessary for the interpretation of the test results, include where relevant, a statement of compliance/non-compliance with requirements and/or specifications.
Details:
V1M2: 5.10.3.1
297. Test Reports
In addition to the requirements listed in 5.10.2, test reports shall, where necessary for the interpretation of the test results, include where applicable, a statement on the estimated uncertainty of measurement; information on uncertainty is needed in test reports when it is relevant to the validity or application of the test results, when a customer's instruction so requires, or when the uncertainty affects compliance to a specification limit.
Details:
V1M2: 5.10.3.1
298. Test Reports
In addition to the requirements listed in 5.10.2, test reports shall, where necessary for the interpretation of the test results, include where appropriate and needed, opinions and interpretations (see 5.10.5).
Details:
V1M2: 5.10.3.1
299. Test Reports
In addition to the requirements listed in 5.10.2, test reports shall, where necessary for the interpretation of the test results, include additional information which may be required by specific methods, customers or groups of customers.
Details:
V1M2: 5.10.3.1
300. Test Reports
In addition to the requirements listed in 5.10.2 and 5.10.3.1, test reports containing the results of sampling shall include the following, where necessary for the interpretation of test results: the date of sampling;
Details:
V1M2: 5.10.3.2
301. Test Reports
In addition to the requirements listed in 5.10.2 and 5.10.3.1, test reports containing the results of sampling shall include the following, where necessary for the interpretation of test results: unambiguous identification of the substance, material or product sampled (including the name of the manufacturer, the model or type of designation and serial numbers as appropriate).
Details:
V1M2: 5.10.3.2
302. Test Reports
In addition to the requirements listed in 5.10.2 and 5.10.3.1, test reports containing the results of sampling shall include the following, where necessary for the interpretation of test results: the location of sampling, including any diagrams, sketches or photographs.
Details:
V1M2: 5.10.3.2
303. Test Reports
In addition to the requirements listed in 5.10.2 and 5.10.3.1, test reports containing the results of sampling shall include the following, where necessary for the interpretation of test results: a reference to the sampling plan and procedures used
Details:
V1M2: 5.10.3.2
304. Test Reports
In addition to the requirements listed in 5.10.2 and 5.10.3.1, test reports containing the results of sampling shall include the following, where necessary for the interpretation of test results: details of any environmental conditions during sampling that may affect the interpretation of the test results.
Details:
V1M2: 5.10.3.2
305. Test Reports
In addition to the requirements listed in 5.10.2 and 5.10.3.1, test reports containing the results of sampling shall include the following, where necessary for the interpretation of test results: any standard or other specification for the sampling method or procedure, and deviations, additions to or exclusions from the specification concerned.
Details:
V1M2: 5.10.3.2
306. Opinions and interpretations
When opinions and interpretations are included, the laboratory shall document the basis upon which the opinions and interpretations have been made. Opinions and interpretations shall be clearly marked as such in a test report.
Details:
NOTE 1: Opinions and interpretations should not be confused with inspections and product certifications as intended in ISO/IEC 17020 and ISO/IEC Guide 65. NOTE 2: Opinions and interpretations included in a test report may comprise, but not be limited to, the following: --an opinion on the statement of compliance/noncompliance of the results with requirements; --ulfilment of contractual requirements; --recommendations on how to use the results; --guidance to be used for improvements. NOTE 3: In many cases it might be appropriate to communicate the opinions and interpretations by direct dialogue with the customer. Such dialogue should be written down. Additional Info: V1M2: 5.10.5
307. Testing and calibration results obtained from subcontractors
When the test report contains results of tests performed by subcontractors, these results shall be clearly identified.
Details:
V1M2: 5.10.6
308. Testing and calibration results obtained from subcontractors
The subcontractor shall report the results in writing or electronically. When a calibration has been subcontracted, the laboratory performing the work shall issue the calibration certificate to the contracting laboratory.
Details:
V1M2: 5.10.6
309. Subcontracting
The accreditation number of the subcontracted environmental laboratory shall be indicated on the final report.
Details:
252.707(b)
310. Electronic transmission of results
In the case of transmission of test or calibration results by telephone, telex, facsimile or other electronic or electromagnetic means, the requirements of this International Standard shall be met (see also 5.4.7).
Details:
V1M2: 5.10.7
311. Format of reports and certificates
The format shall be designed to accommodate each type of test or calibration carried out and to minimize the possibility of misunderstanding or misuse.
Details:
NOTE 1: Attention should be given to the lay-out of the test report or calibration certificate, especially with regard to the presentation of the test or calibration data and ease of assimilation by the reader. NOTE 2: The headings should be standardized as far as possible. Additional Info: V1M2: 5.10.8
312. Amendments to test reports and calibration certificates
Material amendments to a test report or calibration certificate after issue shall be made only in the form of a further document, or data transfer, which includes the statement: “Supplement to Test Report [or Calibration Certificate], serial number... [or as otherwise identified]”, or an equivalent form of wording.
Details:
V1M2: 5.10.9
313. Amendments to test reports and calibration certificates
Such amendments shall meet all the requirements of this International Standard.
Details:
V1M2: 5.10.9
314. Amendments to test reports and calibration certificates
When it is necessary to issue a complete new test report or calibration certificate, this shall be uniquely identified and shall contain a reference to the original that it replaces.
Details:
V1M2: 5.10.9
315. Exceptions
Laboratories operated solely to provide data for compliance purposes (in-house or captive laboratories) shall have all applicable information specified in Section 5.10 readily available for review by the accreditation body.
Details:
Some regulatory reporting requirements or formats, such as monthly operating reports, may not require all items listed below; however, the laboratory shall provide all the required information to their client for use in preparing such regulatory reports. Additional Info: V1M2: 5.10.10
316. Exceptions
Formal reports detailing the information are not required if: a) the in-house laboratory is itself responsible for preparing the regulatory reports; or b) the laboratory provides information to another individual within the organization for preparation of regulatory reports. The facility management shall ensure that the appropriate report items are in the report to the regulatory authority, if such information is required; or c) see Section 5.10.1, paragraph 3.
Details:
(Section 5.10.1, Paragraph 3: "In the case of tests or calibrations performed for internal customers, or in the case of a written agreement with the customer, the results may be reported in a simplified way. Any information listed in 5.10.2 to 5.10.4 which is not reported to the customer shall be readily available in the laboratory which carried out the tests and/or calibrations.") Additional Info: V1M2: 5.10.10
V1M2 Technical Requirements
1. Standard Operating Procedures (SOPs)
Laboratories shall maintain SOPs that accurately reflect all phases of current laboratory activities, such as assessing data integrity, corrective actions, handling customer complaints, and all methods.
Details:
V1M2: 4.2.8.5
2. Standard Operating Procedures (SOPs)
These documents, for example, may be equipment manuals provided by the manufacturer, or internally written documents with adequate detail to allow someone similarly qualified, other than the analyst, to reproduce the procedures used to generate the test result.
Details:
V1M2: 4.2.8.5.a
3. Standard Operating Procedures (SOPs)
The relevant SOPs shall be readily accessible to all personnel.
Details:
V1M2: 4.2.8.5.b
4. Standard Operating Procedures (SOPs)
Each SOP shall clearly indicate the effective date of the document, the revision number, and the signature(s) of the approving authority.
Details:
V1M2: 4.2.8.5.c
5. Standard Operating Procedures (SOPs)
Documents that contain sufficient information to perform the tests, do not need to be supplemented or rewritten as internal procedures if the documents are written in a way that they can be used as written. Any changes, including the use of a selected option, shall be documented and included in the laboratory’s method records.
Details:
V1M2: 4.2.8.5.d
6. Standard Operating Procedures (SOPs)
The laboratory shall have and maintain an SOP for each accredited analyte or method.
Details:
V1M2: 4.2.8.5.e
7. Standard Operating Procedures (SOPs)
The SOP may be a copy of a published or referenced method or may be written by the laboratory. In cases where modifications to the published method have been made by the laboratory or where the referenced method is ambiguous or provides insufficient detail, these changes or clarifications shall be clearly described.
Details:
V1M2: 4.2.8.5.f
8. Standard Operating Procedures (SOPs)
Each method shall include or reference the following topic where applicable: identification of the method
Details:
V1M2: 4.2.8.5.f
9. Standard Operating Procedures (SOPs)
Each method shall include or reference the following topics where applicable: applicable matrix or matrices
Details:
V1M2: 4.2.8.5.f
10. Standard Operating Procedures (SOPs)
Each method shall include or reference the following topics where applicable: limits of detection and quantitation
Details:
V1M2: 4.2.8.5.f
11. Standard Operating Procedures (SOPs)
Each method shall include or reference the following topics where applicable: scope and application, including parameters to be analyzed
Details:
V1M2: 4.2.8.5.f
12. Standard Operating Procedures (SOPs)
Each method shall include or reference the following topics where applicable: summary of the method
Details:
V1M2: 4.2.8.5.f
13. Standard Operating Procedures (SOPs)
Each method shall include or reference the following topics where applicable: definitions
Details:
V1M2: 4.2.8.5.f
14. Standard Operating Procedures (SOPs)
Each method shall include or reference the following topics where applicable: interferences
Details:
V1M2: 4.2.8.5.f
15. Standard Operating Procedures (SOPs)
Each method shall include or reference the following topics where applicable: safety
Details:
V1M2: 4.2.8.5.f
16. Standard Operating Procedures (SOPs)
Each method shall include or reference the following topics where applicable: equipment and supplies
Details:
V1M2: 4.2.8.5.f
17. Standard Operating Procedures (SOPs)
Each method shall include or reference the following topics where applicable: reagents and standards
Details:
V1M2: 4.2.8.5.f
18. Standard Operating Procedures (SOPs)
Each method shall include or reference the following topics where applicable: sample collection, preservation, shipment and storage
Details:
V1M2: 4.2.8.5.f
19. Standard Operating Procedures (SOPs)
Each method shall include or reference the following topics where applicable: quality control
Details:
V1M2: 4.2.8.5.f
20. Standard Operating Procedures (SOPs)
Each method shall include or reference the following topics where applicable: calibration and standardization
Details:
V1M2: 4.2.8.5.f
21. Standard Operating Procedures (SOPs)
Each method shall include or reference the following topics where applicable: procedure
Details:
V1M2: 4.2.8.5.f
22. Standard Operating Procedures (SOPs)
Each method shall include or reference the following topics where applicable: data analysis and calculations
Details:
V1M2: 4.2.8.5.f
23. Standard Operating Procedures (SOPs)
Each method shall include or reference the following topics where applicable: method performance
Details:
V1M2: 4.2.8.5.f
24. Standard Operating Procedures (SOPs)
Each method shall include or reference the following topics where applicable: pollution prevention
Details:
V1M2: 4.2.8.5.f
25. Standard Operating Procedures (SOPs)
Each method shall include or reference the following topics where applicable: data assessment and acceptance criteria for quality control measures
Details:
V1M2: 4.2.8.5.f
26. Standard Operating Procedures (SOPs)
Each method shall include or reference the following topics where applicable: corrective actions for out-of-control data
Details:
V1M2: 4.2.8.5.f
27. Standard Operating Procedures (SOPs)
Each method shall include or reference the following topics where applicable: contingencies for handling out-of-control or unacceptable data
Details:
V1M2: 4.2.8.5.f
28. Standard Operating Procedures (SOPs)
Each method shall include or reference the following topics where applicable: waste management
Details:
V1M2: 4.2.8.5.f
29. Standard Operating Procedures (SOPs)
Each method shall include or reference the following topics where applicable: references
Details:
V1M2: 4.2.8.5.f
30. Standard Operating Procedures (SOPs)
Each method shall include or reference the following topics where applicable: any tables, diagrams, flowcharts and validation data
Details:
V1M2: 4.2.8.5.f
31. Technical Records
The laboratory shall retain records of original observations, derived data and sufficient information to establish an audit trail, calibration records, staff records and a copy of each test report or calibration certificate issued, for a defined period.
Details:
V1M2: 4.13.2.1
32. Technical Records
The records for each test or calibration shall contain sufficient information to facilitate, if possible, identification of factors affecting the uncertainty and to enable the test or calibration to be repeated under conditions as close as possible to the original.
Details:
V1M2: 4.13.2.1
33. Technical Records
The records shall include the identity of personnel responsible for the sampling, performance of each test and/or calibration and checking of results.
Details:
NOTE 1: In certain fields it may be impossible or impractical to retain records of all original observations. NOTE 2: Technical records are accumulations of data (see 5.4.7) and information which result from carrying out tests and/or calibrations and which indicate whether specified quality or process parameters are achieved. They may include forms, contracts, work sheets, work books, check sheets, work notes, control graphs, external and internal test reports and calibration certificates, customers' notes, papers and feedback. Additional Info: V1M2: 4.13.2.1
34. Technical Records
Observations, data and calculations shall be recorded at the time they are made and shall be identifiable to the specific task.
Details:
V1M2: 4.13.2.2
35. Technical Records
When mistakes occur in records, each mistake shall be crossed out, not erased, made illegible or deleted, and the correct value entered alongside.
Details:
V1M2: 4.13.2.3
36. Technical Records
All such alterations to records shall be signed or initialed by the person making the correction.
Details:
V1M2: 4.13.2.3
37. Technical Records
In the case of records stored electronically, equivalent measures shall be taken to avoid loss or change of original data.
Details:
V1M2: 4.13.2.3
38. Additional Requirements
The laboratory shall establish a record keeping system that allows the history of the sample and associated data to be readily understood through the documentation.
Details:
V1M2: 4.13.3.a
39. Additional Requirements
This system shall produce unequivocal, accurate records that document all laboratory activities such as laboratory facilities, equipment, analytical methods, and related laboratory activities, such as sample receipt, sample preparation, or data verification, and inter-laboratory transfers of samples and/or extracts.
Details:
V1M2: 4.13.3.a
40. Additional Requirements
The laboratory shall retain all records for a minimum of five years from generation of the last entry in the records.
Details:
V1M2: 4.13.3.b
41. Additional Requirements
Records shall be available to the accreditation body.
Details:
V1M2: 4.13.3.c
42. Additional Requirements
Records that are stored only on electronic media shall be supported by the hardware and software necessary for their retrieval.
Details:
V1M2: 4.13.3.d
43. Additional Requirements
Access to archived information shall be documented with an access log.
Details:
V1M2: 4.13.3.e
44. Additional Requirements
All information necessary for the historical reconstruction of data shall be maintained by the laboratory.
Details:
V1M2: 4.13.3.f
45. Additional Requirements
Historical reconstruction information shall include all raw data, whether hard copy or electronic, for calibrations, samples and quality control measures, including analysts’ worksheets and data output records (chromatograms, strip charts, and other instrument response readout records)
Details:
V1M2: 4.13.3.f
46. Additional Requirements
Historical reconstruction information shall include a written description or reference to the specific test method used, which includes a description of the specific computational steps used to translate parametric observations into a reportable analytical value
Details:
V1M2: 4.13.3.f
47. Additional Requirements
Historical reconstruction information shall include laboratory sample ID code.
Details:
V1M2: 4.13.3.f
48. Additional Requirements
Historical reconstruction information shall include the date of analysis.
Details:
V1M2: 4.13.3.f
49. Additional Requirements
Historical reconstruction information shall include time of analysis is required if the holding time is seventy-two hours or less.
Details:
V1M2: 4.13.3.f
50. Additional Requirements
Historical reconstruction information shall include time of analysis is required when time critical steps are included in the analysis (e.g., extractions and incubations).
Details:
V1M2: 4.13.3.f
51. Additional Requirements
Historical reconstruction information shall include instrumentation identification and instrument operating conditions/parameters (or reference to such data).
Details:
V1M2: 4.13.3.f
52. Additional Requirements
Historical reconstruction information shall include all manual calculations.
Details:
V1M2: 4.13.3.f
53. Additional Requirements
Historical reconstruction information shall include analyst's or operator's initials/signature or electronic identification.
Details:
V1M2: 4.13.3.f
54. Additional Requirements
Historical reconstruction information shall include sample preparation, including cleanup, separation protocols, incubation periods or subculture, ID codes, volumes, weights, instrument printouts, meter readings, calculations, reagents.
Details:
V1M2: 4.13.3.f
55. Additional Requirements
Historical reconstruction information shall include test results
Details:
V1M2: 4.13.3.f
56. Additional Requirements
Historical reconstruction information shall include standard and reagent origin, receipt, preparation, and use.
Details:
V1M2: 4.13.3.f
57. Additional Requirements
Historical reconstruction information shall include calibration criteria, frequency and acceptance criteria.
Details:
V1M2: 4.13.3.f
58. Additional Requirements
Historical reconstruction information shall include data and statistical calculations, review, confirmation, interpretation, assessment and reporting conventions.
Details:
V1M2: 4.13.3.f
59. Additional Requirements
Historical reconstruction information shall include quality control protocols and assessment.
Details:
V1M2: 4.13.3.f
60. Additional Requirements
Historical reconstruction information shall include electronic data security, software documentation and verification, software and hardware audits, backups, and records of any changes to automated data entries.
Details:
V1M2: 4.13.3.f
61. Additional Requirements
Historical reconstruction information shall include method performance criteria including expected quality control requirements.
Details:
V1M2: 4.13.3.f
62. Additional Requirements
Historical reconstruction information shall include proficiency test results.
Details:
V1M2: 4.13.3.f
63. Additional Requirements
Historical reconstruction information shall include records of demonstration of capability for each analyst.
Details:
V1M2: 4.13.3.f
64. Additional Requirements
Historical reconstruction information shall include a record of names, initials, and signatures for all individuals who are responsible for signing or initialing any laboratory record.
Details:
V1M2: 4.13.3.f
65. Additional Requirements
All generated data, except those that are generated by automated data collection systems, shall be recorded legibly in permanent ink.
Details:
V1M2: 4.13.3.g
66. Additional Requirements
An individual making corrections to records shall date and initial the correction.
Details:
V1M2: 4.13.3.g
67. Additional Requirements
Corrections due to reasons other than transcription errors shall specify the reason for the correction.
Details:
V1M2: 4.13.3.g
68. Additional Requirements
The laboratory shall have a plan to ensure that the records are maintained or transferred according to the clients’ instructions in the event that a laboratory transfers ownership or goes out of business.
Details:
V1M2: 4.13.3.h
69. Additional Requirements
Appropriate regulatory and state legal requirements concerning laboratory records shall be followed.
Details:
V1M2: 4.13.3.h
70. Additional Requirements
The laboratory shall take account of these factors (V1M2 5.1.1) in developing test and calibration methods and procedures, in the training and qualification of personnel, and in the selection and calibration of the equipment it uses.
Details:
Many factors determine the correctness and reliability of the tests and/or calibrations performed by a laboratory. These factors include contributions from: - human factors (5.2); - accommodation and environmental conditions (5.3); - test and calibration methods and method validation (5.4); - equipment (5.5); - measurement traceability (5.6); - sampling (5.7); - the handling of test and calibration items (5.8). The extent to which the factors contribute to the total uncertainty of measurement differs considerably between (types of) tests and between (types of) calibrations. Additional Info: V1M2: 5.1.2
71. Accommodation and Environmental Conditions
Laboratory facilities for testing and/or calibration, including but not limited to energy sources, lighting and environmental conditions, shall be such as to facilitate correct performance of the tests and/or calibrations.
Details:
V1M2: 5.3.1
72. Accommodation and Environmental Conditions
The laboratory shall ensure that the environmental conditions do not invalidate the results or adversely affect the required quality of any measurement.
Details:
V1M2: 5.3.1
73. Accommodation and Environmental Conditions
Particular care shall be taken when sampling and tests and/or calibrations are undertaken at sites other than a permanent laboratory facility.
Details:
V1M2: 5.3.1
74. Accommodation and Environmental Conditions
The technical requirements for accommodation and environmental conditions that can affect the results of tests and calibrations shall be documented.
Details:
V1M2: 5.3.1
75. Accommodation and Environmental Conditions
The laboratory shall monitor, control and record environmental conditions as required by the relevant specifications, methods and procedures or where they influence the quality of the results.
Details:
V1M2: 5.3.2
76. Accommodation and Environmental Conditions
Due attention shall be paid, for example, to biological sterility, dust, electromagnetic disturbances, radiation, humidity, electrical supply, temperature, and sound and vibration levels, as appropriate to the technical activities concerned.
Details:
V1M2: 5.3.2
77. Accommodation and Environmental Conditions
Tests and calibrations shall be stopped when the environmental conditions jeopardize the results of the tests and/or calibrations.
Details:
V1M2: 5.3.2
78. Accommodation and Environmental Conditions
There shall be effective separation between neighboring areas in which there are incompatible activities.
Details:
V1M2: 5.3.3
79. Accommodation and Environmental Conditions
Measures shall be taken to prevent cross-contamination.
Details:
V1M2: 5.3.3
80. Accommodation and Environmental Conditions
Access to and use of areas affecting the quality of the tests and/or calibrations shall be controlled.
Details:
V1M2: 5.3.4
81. Accommodation and Environmental Conditions
The laboratory shall determine the extent of control based on its particular circumstances.
Details:
V1M2: 5.3.4
82. Accommodation and Environmental Conditions
Measures shall be taken to ensure good housekeeping in the laboratory.
Details:
V1M2: 5.3.5
83. Accommodation and Environmental Conditions
Special procedures shall be prepared where necessary.
Details:
V1M2: 5.3.5
84. Environmental Test Methods and Method Validation
The laboratory shall use appropriate methods and procedures for all tests and/or calibrations within its scope.
Details:
NOTE: All references to Calibration Laboratories and Calibration Methods in ISO/IEC 17025:2005(E) in these Clauses are not applicable to environmental testing. Additional Info: V1M2: 5.4.1
85. Environmental Test Methods and Method Validation
These include sampling, handling, transport, storage and preparation of items to be tested and/or calibrated, and, where appropriate, an estimation of the measurement uncertainty as well as statistical techniques for analysis of test and/or calibration data.
Details:
V1M2: 5.4.1
86. Environmental Test Methods and Method Validation
The laboratory shall have instructions on the use and operation of all relevant equipment, and on the handling and preparation of items for testing and/or calibration, or both, where the absence of such instructions could jeopardize the results of tests and/or calibrations.
Details:
V1M2: 5.4.1
87. Environmental Test Methods and Method Validation
All instructions, standards, manuals and reference data relevant to the work of the laboratory shall be kept up to date and shall be made readily available to personnel (see 4.3).
Details:
V1M2: 5.4.1
88. Environmental Test Methods and Method Validation
Deviation from test and calibration methods shall occur only if the deviation has been documented, technically justified, authorized, and accepted by the customer.
Details:
NOTE: International, regional or national standards or other recognized specifications that contain sufficient and concise information on how to perform the tests and/or calibrations do not need to be supplemented or rewritten as internal procedures if these standards are written in a way that they can be used as published by the operating staff in a laboratory. It may be necessary to provide additional documentation for optional steps in the method or additional details. Additional Info: V1M2: 5.4.1
89. Selection of Methods
The laboratory shall use test and/or calibration methods, including methods for sampling, which meet the needs of the customer and which are appropriate for the tests and/or calibrations it undertakes.
Details:
V1M2: 5.4.2
90. Selection of Methods
Methods published in international, regional or national standards shall preferably be used.
Details:
V1M2: 5.4.2
91. Selection of Methods
The laboratory shall ensure that it uses the latest valid edition of a standard unless it is not appropriate or possible to do so.
Details:
V1M2: 5.4.2
92. Selection of Methods
When necessary, the standard shall be supplemented with additional details to ensure consistent application.
Details:
V1M2: 5.4.2
93. Selection of Methods
When the customer does not specify the method to be used, the laboratory shall select appropriate methods that have been published either in international, regional or national standards, or by reputable technical organizations, or in relevant scientific texts or journals, or as specified by the manufacturer of the equipment.
Details:
V1M2: 5.4.2
94. Selection of Methods
Laboratory-developed methods or methods adopted by the laboratory may also be used if they are appropriate for the intended use and if they are validated.
Details:
V1M2: 5.4.2
95. Selection of Methods
The customer shall be informed as to the method chosen.
Details:
V1M2: 5.4.2
96. Selection of Methods
The laboratory shall confirm that it can properly operate standard methods before introducing the tests or calibrations.
Details:
V1M2: 5.4.2
97. Selection of Methods
If the standard method changes, the confirmation shall be repeated.
Details:
V1M2: 5.4.2
98. Selection of Methods
The laboratory shall inform the customer when the method proposed by the customer is considered to be inappropriate or out of date.
Details:
V1M2: 5.4.2
99. Laboratory-Developed Methods
The introduction of test and calibration methods developed by the laboratory for its own use shall be a planned activity and shall be assigned to qualified personnel equipped with adequate resources. Plans shall be updated as development proceeds and effective communication amongst all personnel involved shall be ensured.
Details:
Non-Standard Methods (ISO/IEC 17025:2005(E), Clause 5.4.4) and 5.4.5) are not applicable in this module and are addressed in specific technical modules based on technology. Additional Info: V1M2: 5.4.3
100. Estimation of Analytical Uncertainty
Environmental testing laboratories shall have a procedure(s) for estimating analytical uncertainty.
Details:
Clause 5.4.6 of the ISO/IEC/IEC 17025:2005(E) concerning calibration testing does not apply. The following requirement replaces the ISO/IEC Clause. Additional Info: V1M2: 5.4.6
101. Estimation of Analytical Uncertainty
Quality control measurement data may be used to determine analytical uncertainty.
Details:
V1M2: 5.4.6
102. Control of Data
Calculations and data transfers shall be subject to appropriate checks in a systematic manner.
Details:
V1M2: 5.4.7.1
103. Control of Data
When computers or automated equipment are used for the acquisition, processing, recording, reporting, storage or retrieval of test or calibration data, the laboratory shall ensure that computer software developed by the user is documented in sufficient detail.
Details:
V1M2: 5.4.7.2
104. Control of Data
When computers or automated equipment are used for the acquisition, processing, recording, reporting, storage or retrieval of test or calibration data, the laboratory shall ensure that computer software developed by the user is suitably validated as being adequate for use.
Details:
V1M2: 5.4.7.2
105. Control of Data
When computers or automated equipment are used for the acquisition, processing, recording, reporting, storage or retrieval of test or calibration data, the laboratory shall ensure that procedures are established and implemented for protecting the data.
Details:
V1M2: 5.4.7.2
106. Control of Data
When computers or automated equipment are used for the acquisition, processing, recording, reporting, storage or retrieval of test or calibration data, the laboratory shall ensure that such procedures shall include, but not be limited to, integrity and confidentiality of data entry or collection, data storage, data transmission and data processing.
Details:
V1M2: 5.4.7.2
107. Control of Data
When computers or automated equipment are used for the acquisition, processing, recording, reporting, storage or retrieval of test or calibration data, the laboratory shall ensure that computers and automated equipment are maintained to ensure proper functioning.
Details:
V1M2: 5.4.7.2
108. Control of Data
When computers or automated equipment are used for the acquisition, processing, recording, reporting, storage or retrieval of test or calibration data, the laboratory shall ensure that computers and automated equipment are provided with the environmental and operating conditions necessary to maintain the integrity of test and calibration data.
Details:
NOTE: Commercial off-the-shelf software (e.g. word processing, database and statistical programmes) in general use within their designed application range may be considered to be sufficiently validated. However, laboratory software configuration/modifications should be validated as in 5.4.7.2 a). Additional Info: V1M2: 5.4.7.2
109. Calibration Requirements
The laboratory shall be furnished with all items of sampling, measurement and test equipment required for the correct performance of the tests and/or calibrations (including sampling, preparation of test and/or calibration items, processing and analysis of test and/or calibration data).
Details:
V1M2: 5.5.1
110. Calibration Requirements
In those cases where the laboratory needs to use equipment outside its permanent control, it shall ensure that the requirements of this International Standard are met.
Details:
V1M2: 5.5.1
111. Calibration Requirements
Equipment and its software used for testing, calibration and sampling shall be capable of achieving the accuracy required and shall comply with specifications relevant to the tests and/or calibrations concerned.
Details:
V1M2: 5.5.2
112. Calibration Requirements
Calibration programmes shall be established for key quantities or values of the instruments where these properties have a significant effect on the results.
Details:
V1M2: 5.5.2
113. Calibration Requirements
Before being placed into service, equipment (including that used for sampling) shall be calibrated or checked to establish that it meets the laboratory's specification requirements and complies with the relevant standard specifications.
Details:
V1M2: 5.5.2
114. Calibration Requirements
It (equipment) shall be checked and/or calibrated before use (see 5.6).
Details:
V1M2: 5.5.2
115. Calibration Requirements
Equipment shall be operated by authorized personnel.
Details:
V1M2: 5.5.3
116. Calibration Requirements
Up-to-date instructions on the use and maintenance of equipment (including any relevant manuals provided by the manufacturer of the equipment) shall be readily available for use by the appropriate laboratory personnel.
Details:
V1M2: 5.5.3
117. Calibration Requirements
Each item of equipment and its software used for testing and calibration and significant to the result shall, when practicable, be uniquely identified.
Details:
V1M2: 5.5.4
118. Calibration Requirements
Records shall be maintained of each item of equipment and its software significant to the tests and/or calibrations performed.
Details:
V1M2: 5.5.5
119. Calibration Requirements
The records shall include the identity of the item of equipment
Details:
V1M2: 5.5.5
120. Calibration Requirements
The records shall include at the identity of the software.
Details:
V1M2: 5.5.5
121. Calibration Requirements
The records shall include the manufacturer's name
Details:
V1M2: 5.5.5
122. Calibration Requirements
The records shall include type identification
Details:
V1M2: 5.5.5
123. Calibration Requirements
The records shall include serial number or other unique identification.
Details:
V1M2: 5.5.5
124. Calibration Requirements
The records shall include checks that equipment complies with the specification (see 5.5.2).
Details:
V1M2: 5.5.5
125. Calibration Requirements
The records shall include the current location, where appropriate.
Details:
V1M2: 5.5.5
126. Calibration Requirements
The records shall include the manufacturer's instructions, if available, or reference to their location.
Details:
V1M2: 5.5.5
127. Calibration Requirements
The records shall include dates, results and copies of reports and certificates of all calibrations.
Details:
V1M2: 5.5.5
128. Calibration Requirements
The records shall include dates, results and copies of reports and certificates of all adjustments.
Details:
V1M2: 5.5.5
129. Calibration Requirements
The records shall include dates, results and copies of reports and certificates of all acceptance criteria.
Details:
V1M2: 5.5.5
130. Calibration Requirements
The records shall include the due date of next calibration.
Details:
V1M2: 5.5.5
131. Calibration Requirements
The records shall include the maintenance plan, where appropriate.
Details:
V1M2: 5.5.5
132. Calibration Requirements
The records shall include and maintenance carried out to date.
Details:
V1M2: 5.5.5
133. Calibration Requirements
The records shall include and maintenance carried out to date.
Details:
V1M2: 5.5.5
134. Calibration Requirements
The records shall include any damage, malfunction, modification or repair to the equipment.
Details:
V1M2: 5.5.5
135. Calibration Requirements
The laboratory shall have procedures for safe handling, transport, storage, use and planned maintenance of measuring equipment to ensure proper functioning and in order to prevent contamination or deterioration.
Details:
NOTE: Additional procedures may be necessary when measuring equipment is used outside the permanent laboratory for tests, calibrations or sampling. Additional Info: V1M2: 5.5.6
136. Calibration Requirements
Equipment that has been subjected to overloading or mishandling, gives suspect results, or has been shown to be defective or outside specified limits, shall be taken out of service
Details:
V1M2: 5.5.7
137. Calibration Requirements
It (equipment) shall be isolated to prevent its use or clearly labeled or marked as being out of service until it has been repaired and shown by calibration or test to perform correctly.
Details:
V1M2: 5.5.7
138. Calibration Requirements
The laboratory shall examine the effect of the defect or departure from specified limits on previous tests and/or calibrations and shall institute the "Control of nonconforming work" procedure (see 4.9).
Details:
V1M2: 5.5.7
139. Calibration Requirements
Whenever practicable, all equipment under the control of the laboratory and requiring calibration shall be labeled, coded or otherwise identified to indicate the status of calibration
Details:
V1M2: 5.5.8
140. Calibration Requirements
Whenever practicable, all equipment under the control of the laboratory and requiring calibration shall be labeled, coded or otherwise identified to indicate the date when last calibrated
Details:
V1M2: 5.5.8
141. Calibration Requirements
Whenever practicable, all equipment under the control of the laboratory and requiring calibration shall be labeled, coded or otherwise identified to indicate the date or expiration criteria when recalibration is due.
Details:
V1M2: 5.5.8
142. Calibration Requirements
When, for whatever reason, equipment goes outside the direct control of the laboratory, the laboratory shall ensure that the function and calibration status of the equipment are checked and shown to be satisfactory before the equipment is returned to service.
Details:
V1M2: 5.5.9
143. Calibration Requirements
When intermediate checks are needed to maintain confidence in the calibration status of the equipment, these checks shall be carried out according to a defined procedure.
Details:
V1M2: 5.5.10
144. Calibration Requirements
Where calibrations give rise to a set of correction factors, the laboratory shall have procedures to ensure that copies (e.g. in computer software) are correctly updated.
Details:
V1M2: 5.5.11
145. Calibration Requirements
Test and calibration equipment, including both hardware and software, shall be safeguarded from adjustments which would invalidate the test and/or calibration results.
Details:
NOTE: ISO/IEC Clauses 5.5.1 to 5.5.12 apply with respect to equipment in environmental testing laboratories. Additional Info: V1M2: 5.5.12
146. Support Equipment
All support equipment shall be maintained in proper working order.
Details:
V1M2: 5.5.13.1.a
147. Support Equipment
The records of all repair and maintenance activities, including service calls, shall be kept.
Details:
V1M2: 5.5.13.1.a
148. Support Equipment
All support equipment shall be calibrated or verified at least annually, using a recognized National Metrology Institute, such as NIST, traceable references when available, bracketing the range of use.
Details:
V1M2: 5.5.13.1.b
149. Support Equipment
The results of such calibration or verification shall be within the specifications required of the application for which this equipment is used or: i) the equipment shall be removed from service until repaired; or ii) the laboratory shall maintain records of established correction factors to correct all measurements.
Details:
V1M2: 5.5.13.1.b
150. Support Equipment
Raw data records shall be retained to document equipment performance.
Details:
V1M2: 5.5.13.1.c
151. Support Equipment
On each day the equipment is used, balances, ovens, refrigerators, freezers and water baths shall be checked and documented.
Details:
V1M2: 5.5.13.1.d
152. Support Equipment
The acceptability for use or continued use shall be according to the needs of the analysis or application for which the equipment is being used.
Details:
V1M2: 5.5.13.1.d
153. Support Equipment
Volumetric dispensing devices (except Class A glassware and Glass microliter syringes) shall be checked for accuracy on a quarterly basis.
Details:
V1M2: 5.5.13.1.e
154. Measurement Traceability - Reference Standards
The laboratory shall have a programme and procedure for the calibration of its reference standards.
Details:
V1M2: 5.6.3.1
155. Measurement Traceability - Reference Standards
Reference standards shall be calibrated by a body that can provide traceability as described in 5.6.2.1.
Details:
V1M2: 5.6.3.1
156. Measurement Traceability - Reference Standards
Such reference standards of measurement held by the laboratory shall be used for calibration only and for no other purpose, unless it can be shown that their performance as reference standards would not be invalidated.
Details:
V1M2: 5.6.3.1
157. Measurement Traceability - Reference Standards
Reference standards shall be calibrated before and after any adjustment.
Details:
V1M2: 5.6.3.1
158. Measurement Traceability - Reference Standards
Reference Standards: Where commercially available, this traceability shall be to a national standard of measurement.
Details:
V1M2: 5.6.4.1.a
159. Reference Materials
Reference materials shall, where possible, be traceable to SI units of measurement, or to certified reference materials
Details:
V1M2: 5.6.3.2
160. Reference Materials
Internal reference materials shall be checked as far as is technically and economically practicable.
Details:
V1M2: 5.6.3.2
161. Reference Materials
Reference Materials: Where possible, traceability shall be to national or international standards of measurement or to national or international standard reference materials.
Details:
V1M2: 5.6.4.1.b
162. Reference Materials
Internal reference materials shall be checked as far as is technically and economically practicable.
Details:
V1M2: 5.6.4.1.b
163. Intermediate Checks
Checks needed to maintain confidence in the calibration status of reference, primary, transfer or working standards and reference materials shall be carried out according to defined procedures and schedules.
Details:
V1M2: 5.6.3.3
164. Transport and Storage
The laboratory shall have procedures for safe handling, transport, storage and use of reference standards and reference materials in order to prevent contamination or deterioration and in order to protect their integrity.
Details:
NOTE: Additional procedures may be necessary when reference standards and reference materials are used outside the permanent laboratory for tests, calibrations or sampling. Additional Info: V1M2: 5.6.3.4
165. Documentation and Labeling
Documented procedures shall exist for the purchase, receipt and storage of consumable materials used for the technical operations of the laboratory.
Details:
V1M2: 5.6.4.2
166. Documentation and Labeling
The laboratory shall retain records for all standards, reagents, reference materials, and media, including: --the manufacturer/vendor --the manufacturer’s Certificate of Analysis or purity (if available) --the date of receipt --recommended storage conditions.
Details:
V1M2: 5.6.4.2.a
167. Documentation and Labeling
For original containers, if an expiration date is provided by the manufacturer or vendor it shall be recorded on the container. If an expiration date is not provided by the manufacturer or vendor it is not required.
Details:
V1M2: 5.6.4.2.b
168. Documentation and Labeling
Records shall be maintained on standard, reference material, and reagent preparation. These records shall indicate traceability to purchased stocks or neat compounds, reference to the method of preparation, date of preparation, expiration date and preparer's initials
Details:
V1M2: 5.6.4.2.c
169. Documentation and Labeling
All containers of prepared standards, reference materials, and reagents shall bear a unique identifier
Details:
V1M2: 5.6.4.2.d
170. Documentation and Labeling
All containers of prepared standards, reference materials, and reagents shall bear an expiration date.
Details:
V1M2: 5.6.4.2.d
171. Documentation and Labeling
Procedures shall be in place to ensure prepared reagents meet the requirements of the method.
Details:
V1M2: 5.6.4.2.e
172. Documentation and Labeling
Standards, reference materials, and reagents shall not be used after their expiration dates unless their reliability is verified by the laboratory.
Details:
V1M2: 5.6.4.2.f
173. Additional Requirements - Sample Storage and Disposal
Samples shall be stored according to the conditions specified by preservation protocols.
Details:
i) Samples that require thermal preservation shall be stored under refrigeration that is +/-2°C of the specified preservation temperature unless regulatory or method specific criteria exist. i) For samples with a specified storage temperature of 4°C, storage at a temperature above the freezing point of water to 6°C shall be acceptable. Additional Info: V1M2: 5.8.9.a
174. Additional Requirements - Sample Storage and Disposal
Samples shall be stored away from all standards, reagents, and food. Samples shall be stored in such a manner to prevent cross contamination.
Details:
V1M2: 5.8.9.a
175. Additional Requirements - Sample Storage and Disposal
Sample fractions, extracts, leachates and other sample preparation products shall be stored according to Section 5.8.9 a) above or according to specifications in the method.
Details:
V1M2: 5.8.9.b
176. Additional Requirements - Sample Storage and Disposal
The laboratory shall have SOPs for the disposal of samples, digestates, leachates and extracts or other sample preparation products.
Details:
V1M2: 5.8.9.c
177. Quality Assurance for Environmental Testing
The laboratory shall have quality control procedures for monitoring the validity of tests and calibrations undertaken.
Details:
V1M2: 5.9.1
178. Quality Assurance for Environmental Testing
The resulting data shall be recorded in such a way that trends are detectable and, where practicable, statistical techniques shall be applied to the reviewing of the results.
Details:
V1M2: 5.9.1
179. Quality Assurance for Environmental Testing
This monitoring shall be planned and reviewed and may include, but not be limited to, the following: regular use of certified reference materials and/or internal quality control using secondary reference materials.
Details:
V1M2: 5.9.1
180. Quality Assurance for Environmental Testing
This monitoring shall be planned and reviewed and may include, but not be limited to, the following: participation in interlaboratory comparison or proficiency-testing programmes.
Details:
V1M2: 5.9.1
181. Quality Assurance for Environmental Testing
This monitoring shall be planned and reviewed and may include, but not be limited to, the following: replicate tests or calibrations using the same or different methods.
Details:
V1M2: 5.9.1
182. Quality Assurance for Environmental Testing
This monitoring shall be planned and reviewed and may include, but not be limited to, the following: retesting or recalibration of retained items.
Details:
V1M2: 5.9.1
183. Quality Assurance for Environmental Testing
This monitoring shall be planned and reviewed and may include, but not be limited to, the following: correlation of results for different characteristics of an item.
Details:
NOTE: The selected methods should be appropriate for the type and volume of the work undertaken. Additional Info: V1M2: 5.9.1
184. Quality Assurance for Environmental Testing
Quality control data shall be analyzed and, where they are found to be outside pre-defined criteria, planned action shall be taken to correct the problem and to prevent incorrect results from being reported.
Details:
V1M2: 5.9.2
185. Essential Quality Control Procedures
All laboratories shall have detailed written protocols in place to monitor positive and negative controls (see technical modules), chemical or microbiological as applicable to the test type, to monitor tests such as blanks, matrix spikes, reference toxicants.
Details:
These general quality control principles shall apply, where applicable, to all testing laboratories. The manner in which they are implemented is dependent on the types of tests performed by the laboratory (i.e., asbestos, chemical, microbiological, radiological, toxicity) and are further described in Technical Modules. The standards for any given test type shall assure that the applicable principles are addressed. Additional Info: V1M2: 5.9.3.a
186. Essential Quality Control Procedures
All laboratories shall have detailed written protocols in place to monitor tests to define the variability and/or repeatability of the laboratory results such as replicates.
Details:
These general quality control principles shall apply, where applicable, to all testing laboratories. The manner in which they are implemented is dependent on the types of tests performed by the laboratory (i.e., asbestos, chemical, microbiological, radiological, toxicity) and are further described in Technical Modules. The standards for any given test type shall assure that the applicable principles are addressed. Additional Info: V1M2: 5.9.3.a
187. Essential Quality Control Procedures
All laboratories shall have detailed written protocols in place to monitor measures to assure the accuracy of the method including calibration and/or continuing calibrations, use of certified reference materials, proficiency test samples, or other measures.
Details:
These general quality control principles shall apply, where applicable, to all testing laboratories. The manner in which they are implemented is dependent on the types of tests performed by the laboratory (i.e., asbestos, chemical, microbiological, radiological, toxicity) and are further described in Technical Modules. The standards for any given test type shall assure that the applicable principles are addressed. Additional Info: V1M2: 5.9.3.a
188. Essential Quality Control Procedures
All laboratories shall have detailed written protocols in place to monitor measures to evaluate method capability, such as limit of detection and limit of quantitation or range of applicability such as linearity.
Details:
These general quality control principles shall apply, where applicable, to all testing laboratories. The manner in which they are implemented is dependent on the types of tests performed by the laboratory (i.e., asbestos, chemical, microbiological, radiological, toxicity) and are further described in Technical Modules. The standards for any given test type shall assure that the applicable principles are addressed. Additional Info: V1M2: 5.9.3.a
189. Essential Quality Control Procedures
All laboratories shall have detailed written protocols in place to monitor selection of appropriate formulae to reduce raw data to final results such as regression analysis, comparison to internal/external standard calculations, and statistical analyses.
Details:
These general quality control principles shall apply, where applicable, to all testing laboratories. The manner in which they are implemented is dependent on the types of tests performed by the laboratory (i.e., asbestos, chemical, microbiological, radiological, toxicity) and are further described in Technical Modules. The standards for any given test type shall assure that the applicable principles are addressed. Additional Info: V1M2: 5.9.3.a
190. Essential Quality Control Procedures
All laboratories shall have detailed written protocols in place to monitor selection and use of reagents and standards of appropriate quality.
Details:
These general quality control principles shall apply, where applicable, to all testing laboratories. The manner in which they are implemented is dependent on the types of tests performed by the laboratory (i.e., asbestos, chemical, microbiological, radiological, toxicity) and are further described in Technical Modules. The standards for any given test type shall assure that the applicable principles are addressed. Additional Info: V1M2: 5.9.3.a
191. Essential Quality Control Procedures
All laboratories shall have detailed written protocols in place to monitor measures to assure the selectivity of the test for its intended purpose.
Details:
These general quality control principles shall apply, where applicable, to all testing laboratories. The manner in which they are implemented is dependent on the types of tests performed by the laboratory (i.e., asbestos, chemical, microbiological, radiological, toxicity) and are further described in Technical Modules. The standards for any given test type shall assure that the applicable principles are addressed. Additional Info: V1M2: 5.9.3.a
192. Essential Quality Control Procedures
All laboratories shall have detailed written protocols in place to monitor measures to assure constant and consistent test conditions (both instrumental and environmental) where required by the method such as temperature, humidity, light or specific instrument conditions.
Details:
These general quality control principles shall apply, where applicable, to all testing laboratories. The manner in which they are implemented is dependent on the types of tests performed by the laboratory (i.e., asbestos, chemical, microbiological, radiological, toxicity) and are further described in Technical Modules. The standards for any given test type shall assure that the applicable principles are addressed. Additional Info: V1M2: 5.9.3.a
193. Essential Quality Control Procedures
All quality control measures shall be assessed and evaluated on an on-going basis and quality control acceptance criteria shall be used.
Details:
These general quality control principles shall apply, where applicable, to all testing laboratories. The manner in which they are implemented is dependent on the types of tests performed by the laboratory (i.e., asbestos, chemical, microbiological, radiological, toxicity) and are further described in Technical Modules. The standards for any given test type shall assure that the applicable principles are addressed. Additional Info: V1M2: 5.9.3.b
194. Essential Quality Control Procedures
The laboratory shall have procedures for the development of acceptance/rejection criteria where no method or regulatory criteria exist.
Details:
When it is not apparent which is more stringent, the QC in the mandated method or regulations is to be followed. These general quality control principles shall apply, where applicable, to all testing laboratories. The manner in which they are implemented is dependent on the types of tests performed by the laboratory (i.e., asbestos, chemical, microbiological, radiological, toxicity) and are further described in Technical Modules. The standards for any given test type shall assure that the applicable principles are addressed. Additional Info: V1M2: 5.9.3.c
195. Essential Quality Control Procedures
The quality control protocols specified by the laboratory’s SOP shall be followed (see Section 4.2.8.5 in this Standard).
Details:
When it is not apparent which is more stringent, the QC in the mandated method or regulations is to be followed. These general quality control principles shall apply, where applicable, to all testing laboratories. The manner in which they are implemented is dependent on the types of tests performed by the laboratory (i.e., asbestos, chemical, microbiological, radiological, toxicity) and are further described in Technical Modules. The standards for any given test type shall assure that the applicable principles are addressed. Additional Info: V1M2: 5.9.3.c
196. Essential Quality Control Procedures
The laboratory shall ensure that the essential standards outlined in Technical Modules or mandated methods or regulations (whichever are more stringent) are incorporated into their method manuals.
Details:
When it is not apparent which is more stringent, the QC in the mandated method or regulations is to be followed. These general quality control principles shall apply, where applicable, to all testing laboratories. The manner in which they are implemented is dependent on the types of tests performed by the laboratory (i.e., asbestos, chemical, microbiological, radiological, toxicity) and are further described in Technical Modules. The standards for any given test type shall assure that the applicable principles are addressed. Additional Info: V1M2: 5.9.3.c
V1M4 Chemical Testing
1. Method Selection
If there is not a regulatory requirement for the parameter/method combination, the parameter/ method combination need not be validated under 1.5.1b) as a non-reference method if it can be analyzed by another similar reference method of the same matrix and technology. The inclusion of the parameter in the method shall meet all required calibration requirements and the quality control requirements of the method to which the parameter is being added. If no QC exists in the method, the laboratory shall adhere to the requirements outlined in the similar method. For example, when adding acetone to Method 624, the calibration and QC requirements shall follow Method 624.
Details:
-A reference method is a method issued by an organization generally recognized as competent to do so. (When ISO refers to a standard method, that term is equivalent to reference method). -When a laboratory is required to analyze a parameter by a specified method due to a regulatory requirement, the parameter/method combination is recognized as a reference method. Additional Info: V1M4: 1.4
2. Method Selection
A method that meets the above requirement shall be identified in such a way so that there is no confusion that the method has been modified.
Details:
V1M4: 1.4
3. Method Selection
When it is necessary to use methods not covered by reference methods, these shall be subject to agreement with the client and shall include a clear specification of the client's requirements and the purpose of the environmental test.
Details:
V1M4: 1.4
4. Method Selection
The method developed shall have been validated appropriately before use.
Details:
V1M4: 1.4
5. Validation of Methods
The laboratory shall validate non-reference methods, laboratory-designed/developed methods, reference methods used outside their published scope, and amplifications and modifications of reference methods to confirm that the methods are fit for the intended use. The validation shall be as extensive as is necessary to meet the needs of the given application or field of application. The laboratory shall record the results obtained, the procedure used for the validation, and a statement as to whether the method is fit for the intended use. In the absence of other specifications, the minimum requirements for method validation are given in Sections 1.5.2, 1.5.3 and 1.5.4.
Details:
V1M4: 1.5.1.b
6. Limit of Detection and Limit of Quantitation (However named)
Procedures used for determining limits of detection and quantitation shall be documented. Documentation shall include the quality system matrix type. All supporting data shall be retained.
Details:
V1M4: 1.5.2
7. Limit of Detection (LOD)
If the laboratory is not reporting a value below the Limit of Quantitation, a Limit of Detection study is not required.
Details:
V1M4: 1.5.2.1
8. Limit of Detection (LOD)
The laboratory shall utilize a method that provides an LOD that is appropriate and relevant for the intended use of the data.
Details:
V1M4: 1.5.2.1
9. Limit of Detection (LOD)
If a mandated method or regulation includes protocols for determining detection limits, these shall be followed.
Details:
V1M4: 1.5.2.1
10. Limit of Detection (LOD)
The laboratory shall document how LODs were derived from the determinations. If the protocol for determining the LOD is not specified, the selection of the procedure shall reflect instrument limitations and the intended application of the method.
Details:
V1M4: 1.5.2.1
11. Limit of Detection (LOD)
All sample-processing and analysis steps of the analytical method shall be included in the determination or validation of the LOD.
Details:
V1M4: 1.5.2.1
12. Limit of Detection (LOD)
When required, the laboratory shall determine or verify the LOD for the method for each target analyte of concern in the quality system matrices.
Details:
V1M4: 1.5.2.1.a
13. Limit of Detection (LOD)
The validity of the LOD shall be verified by detection (a value above zero) of the analyte(s) in a QC sample in each quality system matrix. This QC sample shall contain the analyte at no more than 3X the LOD for single analyte tests and 4X the LOD for multiple analyte tests.
Details:
V1M4: 1.5.2.1.b
14. Limit of Detection (LOD)
This verification shall be performed on every instrument that is to be used for analysis of samples and reporting of data. The validity of the LOD shall be verified as part of the LOD determination process. This verification shall be done prior to the use of the LOD for the sample analysis.
Details:
V1M4: 1.5.2.1.b
15. Limit of Detection (LOD)
An LOD study is not required for any component for which spiking solutions or quality control samples are not available such as temperature.
Details:
V1M4: 1.5.2.1.c
16. Limit of Detection (LOD)
The LOD shall be initially determined for the compounds of interest in each method in a quality system matrix in which there are neither target analytes nor interferences at a concentration that would impact the results or the LOD shall be performed in the quality system matrix of interest.
Details:
V1M4: 1.5.2.1.d
17. Limit of Detection (LOD)
An LOD shall be performed each time there is a change in the method that affects how the test is performed, or when a change in instrumentation occurs that affects the sensitivity of the analysis.
Details:
V1M4: 1.5.2.1.e
18. Limit of Detection (LOD)
The LOD, if required, shall be verified annually for each quality system matrix, technology, and analyte.
Details:
V1M4: 1.5.2.1.f
19. Limit of Quantitation (LOQ)
All sample-processing and analysis steps of the analytical method shall be included in the determination of the LOQ.
Details:
V1M4: 1.5.2.2.a
20. Limit of Quantitation (LOQ)
The LOQ study is not required for any component or property for which spiking solutions or quality control samples are not available or otherwise inappropriate (e.g., pH).
Details:
V1M4: 1.5.2.2.b
21. Limit of Quantitation (LOQ)
The validity of the LOQ shall be verified by successful analysis of a QC sample containing the analytes of concern in each quality system matrix at 1 to 2 times the claimed LOQ. A successful analysis is one where the recovery of each analyte is within the laboratory established method acceptance criteria or client data quality objectives for accuracy.
Details:
V1M4: 1.5.2.2.c
22. Limit of Quantitation (LOQ)
When an LOD is determined or verified by the laboratory, the LOQ shall be above the LOD.
Details:
V1M4: 1.5.2.2.d
23. Limit of Quantitation (LOQ)
The LOQ shall be verified annually for each quality system matrix, technology, and analyte. However, the annual LOQ verification is not required if the LOD was determined or verified annually on that instrument.
Details:
V1M4: 1.5.2.2.e
24. Evaluation of Precision and Bias
Reference Methods. The laboratory shall evaluate the precision and bias of a reference method for each analyte of concern for each quality system matrix according to Section 1.6 or alternate documented procedure when the analyte cannot be spiked into the sample matrix and QC samples are not commercially available.
Details:
V1M4: 1.5.3.a
25. Evaluation of Precision and Bias
Non-Reference Methods. For laboratory-developed methods or non-reference methods that were not in use by the laboratory before July 2003, the laboratory shall have a documented procedure to evaluate precision and bias. The laboratory shall also compare results of the precision and bias measurements with criteria established by the client, by criteria given in the reference method or criteria established by the laboratory.
Details:
V1M4: 1.5.3.b
26. Evaluation of Precision and Bias
Precision and bias measurements shall evaluate the method across the analytical calibration range of the method. The laboratory shall also evaluate precision and bias in the relevant quality system matrices and shall process the samples through the entire measurement system for each analyte of interest.
Details:
Examples of a systematic approach to evaluate precision and bias could be the following: i) Analyze QC samples in triplicate containing the analytes of concern at or near the limit of quantitation, at the upper-range of the calibration (upper 20%) and at a mid-range concentration. --Process these samples on different days as three (3) sets of samples through the entire measurement system for each analyte of interest. --Each day, one (1) QC sample at each concentration is analyzed. --A separate method blank shall be subjected to the analytical method along with the QC samples on each of the three (3) days. (Note that the three (3) samples at the LOQ concentration can demonstrate sensitivity as well.) --For each analyte, calculate the mean recovery for each day, for each level over each day, and for all nine (9) samples. --Calculate the relative standard deviation for each of the separate means obtained. --Compare the standard deviations for the different days and the standard deviations for the different concentrations. --If the different standard deviations are all statistically insignificant (e.g., F-test), then compare the overall mean and standard deviation with the established criteria from above. ii) A validation protocol, such as the Tier I, Tier II, and Tier III requirements in US EPA Office of Water’s Alternate Test Procedure (ATP) approval process. Additional Info: V1M4: 1.5.3.b
27. Evaluation of Precision and Bias
Evaluation of Selectivity: The laboratory shall evaluate selectivity by following the checks established within the method, which may include mass spectral tuning, second column confirmation, ICP inter-element interference checks, chromatography retention time windows, sample blanks, spectrochemical absorption or fluorescence profiles, co-precipitation evaluations, and electrode response factors.
Details:
V1M4: 1.5.4
28. Demonstration of Capability (DOC)
Prior to acceptance and institution of any method for which data will be reported, a satisfactory initial DOC is required
Details:
V1M4: 1.6.1
29. Demonstration of Capability (DOC)
Thereafter, ongoing DOC (Section 1.6.3), as per the quality control requirements in Section 1.7.3 (such as laboratory control samples) is required.
Details:
V1M4: 1.6.1
30. Demonstration of Capability (DOC)
In cases where a laboratory analyzes samples using a method that has been in use by the laboratory for at least one year prior to applying for accreditation, and there have been no significant changes in instrument type, personnel or method, the ongoing DOC shall be acceptable as an initial DOC.
Details:
V1M4: 1.6.1
31. Demonstration of Capability (DOC)
The laboratory shall have records on file to demonstrate that an initial DOC is not required.
Details:
V1M4: 1.6.1
32. Demonstration of Capability (DOC)
For the initial DOC, appropriate records as discussed in Section 1.6.2 shall be completed.
Details:
V1M4: 1.6.1
33. Demonstration of Capability (DOC)
An initial DOC shall be completed each time there is a change in instrument type, personnel, or method.
Details:
V1M4: 1.6.1
34. Demonstration of Capability (DOC)
All demonstrations shall be documented. .
Details:
V1M4: 1.6.1
35. Demonstration of Capability (DOC)
All data applicable to the demonstration shall be retained and readily available at the laboratory.
Details:
V1M4: 1.6.1
36. Initial DOC
An initial DOC shall be conducted prior to using any method, and at any time there is a change in instrument type, personnel or method or any time that a method has not been performed by the laboratory or analyst in a twelve (12) month period.
Details:
V1M4: 1.6.2
37. Initial DOC
The laboratory shall document each initial DOC in a manner such that the following information is readily available for each affected employee: analyst(s) involved in preparation and/or analysis.
Details:
V1M4: 1.6.2.1
38. Initial DOC
The laboratory shall document each initial DOC in a manner such that the following information is readily available for each affected employee: matrix.
Details:
V1M4: 1.6.2.1
39. Initial DOC
The laboratory shall document each initial DOC in a manner such that the following information is readily available for each affected employee: analyte(s), class of analyte(s), or measured parameter(s).
Details:
V1M4: 1.6.2.1
40. Initial DOC
The laboratory shall document each initial DOC in a manner such that the following information is readily available for each affected employee: identification of method(s) performed.
Details:
V1M4: 1.6.2.1
41. Initial DOC
The laboratory shall document each initial DOC in a manner such that the following information is readily available for each affected employee: identification of laboratory-specific SOP used for analysis, including revision number.
Details:
V1M4: 1.6.2.1
42. Initial DOC
The laboratory shall document each initial DOC in a manner such that the following information is readily available for each affected employee: date(s) of analysis.
Details:
V1M4: 1.6.2.1
43. Initial DOC
The laboratory shall document each initial DOC in a manner such that the following information is readily available for each affected employee: summary of analyses, including information outlined in Section 1.6.2.2.c.
Details:
V1M4: 1.6.2.1
44. Initial DOC
If the method or regulation does not specify an initial DOC, the following procedure is acceptable. It is the responsibility of the laboratory to document that other approaches to initial DOC are adequate.
Details:
V1M4: 1.6.2.2
45. Initial DOC
The analyte(s) shall be diluted in a volume of clean quality system matrix (a sample in which no target analytes or interferences are present at concentrations that will impact the results of a specific method) sufficient to prepare four (4) aliquots at the concentration specified, or if unspecified, to a concentration of one (1) to four (4) times the limit of quantitation.
Details:
V1M4: 1.6.2.2.a
46. Initial DOC
At least four (4) aliquots shall be prepared and analyzed according to the method(s) either concurrently or over a period of days.
Details:
V1M4: 1.6.2.2.b
47. Initial DOC
Using all of the results, calculate the mean recovery in the appropriate reporting units and the standard deviations of the sample (in the same units) for each parameter of interest. When it is not possible to determine mean and standard deviations, such as for presence/absence and logarithmic values, the laboratory shall assess performance against established and documented criteria.
Details:
V1M4: 1.6.2.2.c
48. Initial DOC
Compare the information from (c) above to the corresponding acceptance criteria for precision and accuracy in the method (if applicable) or in laboratory-generated acceptance criteria (if there are not established mandatory criteria). If all parameters meet the acceptance criteria, the analysis of actual samples may begin. If any one of the parameters does not meet the acceptance criteria, the performance is unacceptable for that parameter.
Details:
V1M4: 1.6.2.2.d
49. Initial DOC
When one or more of the tested parameters fail at least one of the acceptance criteria, the analyst shall proceed according to: i) Locate and correct the source of the problem and repeat the test for all parameters of interest beginning with b) above. ii) Beginning with b) above, repeat the test for all parameters that failed to meet criteria.
Details:
V1M4: 1.6.2.2.e
50. Initial DOC
Repeated failure, however, confirms a general problem with the measurement system. If this occurs, locate and correct the source of the problem and repeat the test for all compounds of interest beginning with b).
51. Initial DOC
When an analyte not currently found on the laboratory’s list of accredited analytes is added to an existing accredited method, an initial demonstration shall be performed for that analyte.
52. Ongoing DOC
The laboratory shall have a documented procedure describing ongoing DOC. The analyst(s) shall demonstrate on-going capability by meeting the quality control requirements of the method, laboratory SOP, client specifications, and/or this Standard. It is the responsibility of the laboratory to document that other approaches to ongoing DOC are adequate.
53. Ongoing DOC
This on-going demonstration may be one of the following: a) acceptable performance of a blind sample (single blind to the analyst); b) another initial DOC; c) at least four (4) consecutive laboratory control samples with acceptable levels of precision and accuracy. The laboratory shall determine the acceptable limits for precision and accuracy prior to analysis. The laboratory shall tabulate or be able to readily retrieve four (4) consecutive passing LCSs for each method for each analyst each year; d) a documented process of analyst review using QC samples. QC samples can be reviewed to identify patterns for individuals or groups of analysts and determine if corrective action or retraining is necessary; e) if a) through d) are not technically feasible, then analysis of real-world samples with results within a predefined acceptance criteria (as defined by the laboratory or method) shall be performed.
Details:
Note: Successful analysis of a blind performance sample on a similar method using the same technology (e.g., GC/MS volatiles by purge and trap for Methods 524.2, 624 or 5030/8260) would only require documentation for one of the tests. Additional Info: V1M4: 1.6.3.2
54. Technical Requirements - Instrument Calibration
If more stringent standards or requirements are included in a mandated method or by regulation, the laboratory shall demonstrate that such requirements are met. If it is not apparent which Standard is more stringent, then the requirements of the regulation or mandated method are to be followed.
Details:
This module specifies the essential elements that shall define the procedures and documentation for initial instrument calibration and continuing instrument calibration verification to ensure that the data shall be of known quality for the intended use. This Standard does not specify detailed procedural steps (“how to”) for calibration, but establishes the essential elements for selection of the appropriate technique(s). This approach allows flexibility and permits the employment of a wide variety of analytical procedures and statistical approaches currently applicable for calibration. Additional Info: V1M4: 1.7.1.1
55. Initial Calibration
The details of the initial instrument calibration procedures including calculations, integrations, acceptance criteria and associated statistics shall be included or referenced in the method SOP. When initial instrument calibration procedures are referenced in the method, then the referenced material shall be retained by the laboratory and be available for review;
Details:
V1M4: 1.7.1.1.a
56. Initial Calibration
Sufficient raw data records shall be retained to permit reconstruction of the initial instrument calibration (e.g., calibration date, method, instrument, analysis date, each analyte name, analyst’s initials or signature; concentration and response, calibration curve or response factor; or unique equation or coefficient used to reduce instrument responses to concentration);
Details:
V1M4: 1.7.1.1.b
57. Initial Calibration
Sample results shall be quantitated from the initial instrument calibration and may not be quantitated from any continuing instrument calibration verification unless otherwise required by regulation, method, or program;
Details:
V1M4: 1.7.1.1.c
58. Initial Calibration
All initial instrument calibrations shall be verified with a standard obtained from a second manufacturer or from a different lot. Traceability shall be to a national standard, when commercially available;
Details:
V1M4: 1.7.1.1.d
59. Initial Calibration
Criteria for the acceptance of an initial instrument calibration shall be established (e.g., correlation coefficient or relative percent difference). The criteria used shall be appropriate to the calibration technique employed;
Details:
V1M4: 1.7.1.1.e
60. Initial Calibration
The lowest calibration standard shall be at or below the LOQ. Any data reported below the LOQ shall be considered to have an increased quantitative uncertainty and shall be reported using defined qualifiers or explained in the narrative;
Details:
V1M4: 1.7.1.1.f
61. Initial Calibration
The highest calibration standard shall be at or above the highest concentration for which quantitative data are to be reported. Any data reported above the calibration range shall be considered to have an increased quantitative uncertainty and shall be reported using defined qualifiers or explained in the narrative.
Details:
V1M4: 1.7.1.1.g
62. Initial Calibration
The following shall occur for instrument technology (such as ICP or ICP/MS) with validated techniques from manufacturers or methods employing standardization with a zero point and a single point calibration standard: Prior to the analysis of samples, the zero point and single point calibration standard shall be analyzed and the linear range of the instrument shall be established by analyzing a series of standards, one of which shall be at or below the LOQ. Sample results within the established linear range will not require data qualifiers.
Details:
V1M4: 1.7.1.1.h
63. Initial Calibration
The following shall occur for instrument technology (such as ICP or ICP/MS) with validated techniques from manufacturers or methods employing standardization with a zero point and a single point calibration standard: A zero point and single point calibration standard shall be analyzed with each analytical batch.
Details:
V1M4: 1.7.1.1.h
64. Initial Calibration
The following shall occur for instrument technology (such as ICP or ICP/MS) with validated techniques from manufacturers or methods employing standardization with a zero point and a single point calibration standard: A standard corresponding to the limit of quantitation shall be analyzed with each analytical batch and shall meet established acceptance criteria.
Details:
V1M4: 1.7.1.1.h
65. Initial Calibration
The following shall occur for instrument technology (such as ICP or ICP/MS) with validated techniques from manufacturers or methods employing standardization with a zero point and a single point calibration standard: The linearity is verified at a frequency established by the method and/or the manufacturer.
Details:
V1M4: 1.7.1.1.h
66. Initial Calibration
If the initial instrument calibration results are outside established acceptance criteria, corrective actions shall be performed and all associated samples re-analyzed.
Details:
V1M4: 1.7.1.1.i
67. Initial Calibration
If re-analysis of the samples is not possible, data associated with an unacceptable initial instrument calibration shall be reported with appropriate data qualifiers;
Details:
V1M4: 1.7.1.1.i
68. Initial Calibration
If a reference or mandated method does not specify the number of calibration standards, the minimum number of points for establishing the initial instrument calibration shall be three.
Details:
V1M4: 1.7.1.1.j
69. Continuing Calibration
When an initial instrument calibration is not performed on the day of analysis, the validity of the initial calibration shall be verified prior to sample analyses by a continuing instrument calibration verification with each analytical batch.
Details:
V1M4: 1.7.2
70. Continuing Calibration
The details of the continuing instrument calibration procedure, calculations and associated statistics shall be included or referenced in the method SOP.
Details:
V1M4: 1.7.2.a
71. Continuing Calibration
Calibration shall be verified for each compound, element, or other discrete chemical species, except for multi-component analytes such as aroclors, chlordane, total petroleum hydrocarbons, or toxaphene, where a representative chemical, related substance or mixture can be used.
Details:
V1M4: 1.7.2.b
72. Continuing Calibration
Instrument calibration verification shall be performed: i) at the beginning and end of each analytical batch. If an internal standard is used, only one verification needs to be performed at the beginning of the analytical batch; ii) if the time period for calibration or the most recent calibration verification has expired; or iii) for analytical systems that contain a calibration verification requirement.
Details:
V1M4: 1.7.2.c
73. Continuing Calibration
Sufficient raw data records shall be retained to permit reconstruction of the continuing instrument calibration verification (e.g., method, instrument, analysis date, each analyte name, concentration and response, calibration curve or response factor, or unique equations or coefficients used to convert instrument responses into concentrations).
Details:
V1M4: 1.7.2.d
74. Continuing Calibration
Continuing calibration verification records shall explicitly connect the continuing verification data to the initial instrument calibration.
Details:
V1M4: 1.7.2.d
75. Continuing Calibration
Criteria for the acceptance of a continuing instrument calibration verification shall be established.
Details:
V1M4: 1.7.2.e
76. Continuing Calibration
If the continuing instrument calibration verification results obtained are outside the established acceptance criteria and analysis of a second consecutive (immediate) calibration verification fails to produce results within acceptance criteria, corrective actions shall be performed.
Details:
V1M4: 1.7.2.e
77. Continuing Calibration
The laboratory shall demonstrate acceptable performance after corrective action with two consecutive calibration verifications, or a new initial instrument calibration shall be performed.
Details:
V1M4: 1.7.2.e
78. Continuing Calibration
If the laboratory has not verified calibration, sample analyses may not occur until the analytical system is calibrated or calibration verified.
Details:
V1M4: 1.7.2.e
79. Continuing Calibration
If samples are analyzed using a system on which the calibration has not yet been verified the results shall be flagged.
Details:
V1M4: 1.7.2.e
80. Continuing Calibration
Data associated with an unacceptable calibration verification may be fully useable under the following special conditions: i) when the acceptance criteria for the continuing calibration verification are exceeded high (i.e., high bias) and there are associated samples that are non-detects, then those non-detects may be reported. Otherwise the samples affected by the unacceptable calibration verification shall be re-analyzed after a new calibration curve has been established, evaluated and accepted; or ii) when the acceptance criteria for the continuing calibration verification are exceeded low (i.e., low bias), those sample results may be reported if they exceed a maximum regulatory limit/decision level. Otherwise the samples affected by the unacceptable verification shall be re-analyzed after a new calibration curve has been established, evaluated and accepted.
Details:
V1M4: 1.7.2.e
81. Quality Control & Data Acceptance/Rejection Criteria - Negative Control – Method Performance: Method Blank
The method blank is used to assess the samples in the preparation batch for possible contamination during the preparation and processing steps.
Details:
V1M4: 1.7.3.1.a
82. Quality Control & Data Acceptance/Rejection Criteria - Negative Control – Method Performance: Method Blank
The method blank shall be processed along with and under the same conditions as the associated samples to include all steps of the analytical procedure.
Details:
V1M4: 1.7.3.1.a
83. Quality Control & Data Acceptance/Rejection Criteria - Negative Control – Method Performance: Method Blank
Procedures shall be in place to determine if a method blank is contaminated.
Details:
V1M4: 1.7.3.1.a
84. Quality Control & Data Acceptance/Rejection Criteria - Negative Control – Method Performance: Method Blank
Any affected samples associated with a contaminated method blank shall be reprocessed for analysis or the results reported with appropriate data qualifying codes.
Details:
V1M4: 1.7.3.1.a
85. Quality Control & Data Acceptance/Rejection Criteria - Negative Control – Method Performance: Method Blank
The method blank shall be analyzed at a minimum of one (1) per preparation batch.
Details:
V1M4: 1.7.3.1.b
86. Quality Control & Data Acceptance/Rejection Criteria - Negative Control – Method Performance: Method Blank
In those instances for which no separate preparation method is used (for example, volatiles in water), the batch shall be defined as environmental samples that are analyzed together with the same method and personnel, using the same lots of reagents, not to exceed the analysis of twenty (20) environmental samples, not including method blanks, LCS, matrix spikes and matrix duplicates.
Details:
V1M4: 1.7.3.1.b
87. Quality Control & Data Acceptance/Rejection Criteria - Negative Control – Method Performance: Method Blank
The method blank shall consist of a quality system matrix that is similar to the associated samples and is known to be free of the analytes of interest.
Details:
V1M4: 1.7.3.1.c
88. Quality Control & Data Acceptance/Rejection Criteria - Negative Control – Method Performance: Method Blank
Method blanks are not applicable for certain analyses, such as pH, Conductivity, Flash Point and Temperature.
Details:
V1M4: 1.7.3.1.d
89. Quality Control & Data Acceptance/Rejection Criteria - Negative Control – Method Performance: Method Blank
While the goal is to have no detectable contaminants, each method blank shall be critically evaluated as to the nature of the interference and the effect on the analysis of each sample within the batch.
Details:
V1M4: 1.7.4.1
90. Quality Control & Data Acceptance/Rejection Criteria - Negative Control – Method Performance: Method Blank
The concentration of a targeted analyte in the blank is at or above the reporting limit as established by the method or by regulation, AND is greater than 1/10 of the amount measured in the sample;
Details:
If so, the source of contamination shall be investigated and measures taken to minimize or eliminate the problem and affected samples reprocessed or data shall be appropriately qualified. Additional Info: V1M4: 1.7.4.1
91. Quality Control & Data Acceptance/Rejection Criteria - Negative Control – Method Performance: Method Blank
The blank contamination otherwise affects the sample results as per the method requirements or the individual project data quality objectives; and a blank is determined to be contaminated.
Details:
If so, the source of contamination shall be investigated and measures taken to minimize or eliminate the problem and affected samples reprocessed or data shall be appropriately qualified. Additional Info: V1M4: 1.7.4.1
92. Quality Control & Data Acceptance/Rejection Criteria - Negative Control – Method Performance: Method Blank
The cause shall be investigated and measures taken to minimize or eliminate the problem. Samples associated with a contaminated blank shall be evaluated as to the best corrective action for the samples (e.g., reprocessing or data qualifying codes). In all cases the corrective action shall be documented.
Details:
If so, the source of contamination shall be investigated and measures taken to minimize or eliminate the problem and affected samples reprocessed or data shall be appropriately qualified. Additional Info: V1M4: 1.7.4.1
93. Positive Control – Method Performance: Laboratory Control Sample (LCS)
Any affected samples associated with an out of control LCS shall be reprocessed for re-analysis or the results reported with appropriate data qualifying codes.
Details:
V1M4: 1.7.3.2.1
94. Positive Control – Method Performance: Laboratory Control Sample (LCS)
The LCS shall be analyzed at a minimum of one (1) per preparation batch.
Details:
V1M4: 1.7.3.2.2
95. Positive Control – Method Performance: Laboratory Control Sample (LCS)
Exceptions would be for those analytes for which no spiking solutions are available, such as total suspended solids, total dissolved solids, total volatile solids, total solids, pH, color, odor, temperature, dissolved oxygen or turbidity.
Details:
V1M4: 1.7.3.2.2
96. Positive Control – Method Performance: Laboratory Control Sample (LCS)
In those instances for which no separate preparation method is used (example: volatiles in water) the batch shall be defined as environmental samples that are analyzed together with the same method and personnel, using the same lots of reagents, not to exceed the analysis of twenty (20) environmental samples, not including method blanks, LCS, matrix spikes and matrix duplicates.
Details:
V1M4: 1.7.3.2.2
97. Positive Control – Method Performance: Laboratory Control Sample (LCS)
The LCS is a quality system matrix, known to be free of analytes of interest, spiked with known concentrations of analytes.
Details:
Note: The matrix spike may be used in place of this control as long as the acceptance criteria are as stringent as for the LCS. Additional Info: V1M4: 1.7.3.2.3
98. Positive Control – Method Performance: Laboratory Control Sample (LCS)
Alternatively, the LCS may consist of a media containing known and verified concentrations of analytes or as Certified Reference Material (CRM). All analyte concentrations shall be within the calibration range of the methods. The following shall be used in choosing components for the spike mixtures.
Details:
V1M4: 1.7.3.2.3
99. Positive Control – Method Performance: Laboratory Control Sample (LCS)
The components to be spiked shall be as specified by the mandated method or regulation or as requested by the client. In the absence of specified spiking components, the laboratory shall spike per the following: for those components that interfere with an accurate assessment, such as spiking simultaneously with technical chlordane, toxaphene and PCBs, the spike shall be chosen that represents the chemistries and elution patterns of the components to be reported.
Details:
V1M4: 1.7.3.2.3
100. Positive Control – Method Performance: Laboratory Control Sample (LCS)
The components to be spiked shall be as specified by the mandated method or regulation or as requested by the client. In the absence of specified spiking components, the laboratory shall spike per the following: for those methods that have extremely long lists of analytes, a representative number may be chosen. The analytes selected shall be representative of all analytes reported.
Details:
V1M4: 1.7.3.2.3
101. Positive Control – Method Performance: Laboratory Control Sample (LCS)
b) The following criteria shall be used for determining the minimum number of analytes to be spiked. However, the laboratory shall insure that all targeted components are included in the spike mixture over a two (2) year period: i) For methods that include one (1) to ten (10) targets, spike all components. ii) For methods that include eleven (11) to twenty (20) targets, spike at least ten (10) or 80%, whichever is greater. iii) For methods with more than twenty (20) targets, spike at least sixteen (16) components.
Details:
V1M4: 1.7.3.2.3
102. Positive Control – Method Performance: Laboratory Control Sample (LCS)
The results of the individual batch LCS are calculated in percent recovery or other appropriate statistical technique that allows comparison to established acceptance criteria. The laboratory shall document the calculation.
Details:
V1M4: 1.7.3.2.2.a
103. Positive Control – Method Performance: Laboratory Control Sample (LCS)
The individual LCS is compared to the acceptance criteria as published in the mandated method.
Details:
V1M4: 1.7.3.2.2.a
104. Positive Control – Method Performance: Laboratory Control Sample (LCS)
Where there are no established criteria, the laboratory shall determine internal criteria and document the method used to establish the limits or utilize client specified assessment criteria.
Details:
An LCS that is determined to be within the criteria effectively establishes that the analytical system is in control and validates system performance for the samples in the associated batch. Additional Info: V1M4: 1.7.3.2.2.a
105. Positive Control – Method Performance: Laboratory Control Sample (LCS)
Samples analyzed along with an LCS determined to be “out of control” shall be considered suspect and the samples reprocessed and re-analyzed or the data reported with appropriate data qualifying codes. This includes any allowable marginal exceedance as described in b) (requirements 694-695) below.
Details:
i) when the acceptance criteria for the positive control are exceeded high (i.e., high bias) and there are associated samples that are non-detects, then those non-detects may be reported with data qualifying codes; or ii) when the acceptance criteria for the positive control are exceeded low (i.e., low bias), those sample results may be reported if they exceed a maximum regulatory limit/decision level with data qualifying codes. Additional Info: V1M4: 1.7.3.2.2.a
106. Positive Control – Method Performance: Laboratory Control Sample (LCS)
The number of allowable marginal exceedances is as follows: --Number of Analytes in LCS >90 Number Allowed as Marginal Exceedances 5 --Number of Analytes in LCS 71-90 Number Allowed as Marginal Exceedances 4 --Number of Analytes in LCS 51-70 Number Allowed as Marginal Exceedances 3 --Number of Analytes in LCS 31-50 Number Allowed as Marginal Exceedances 2 --Number of Analytes in LCS 11-30 Number Allowed as Marginal Exceedances 1 --Number of Analytes in LCS
Details:
Allowable Marginal Exceedances. If a large number of analytes are in the LCS, it becomes statistically likely that a few will be outside control limits. This may not indicate that the system is out of control, therefore corrective action may not be necessary. Upper and lower marginal exceedance (ME) limits can be established to determine when corrective action is necessary. A ME is defined as being beyond the LCS control limit (three standard deviations), but within the ME limits. ME limits are between three (3) and four (4) standard deviations around the mean. The number of allowable marginal exceedances is based on the number of analytes in the LCS. If more analytes exceed the LCS control limits than is allowed, or if any one analyte exceeds the ME limits, the LCS fails and corrective action is necessary. This marginal exceedance approach is relevant for methods with long lists of analytes. It will not apply to target analyte lists with fewer than eleven analytes. Additional Info: V1M4: 1.7.3.2.2.b
107. Positive Control – Method Performance: Laboratory Control Sample (LCS)
If the same analyte exceeds the LCS control limit consecutively, it is an indication of a systemic problem. The source of the error shall be located and corrective action taken.
Details:
V1M4: 1.7.4.2.b
108. Positive Control – Method Performance: Laboratory Control Sample (LCS)
Laboratories shall have a written procedure to monitor the application of marginal exceedance allowance to the LCS.
Details:
V1M4: 1.7.4.2.b
109. Sample Specific Controls
The laboratory shall document procedures for determining the effect of the sample matrix on method performance.
Details:
These procedures relate to the analyses of quality system matrix specific Quality Control (QC) samples and are designed as data quality indicators for a specific sample using the designated method. These controls alone are not used to judge laboratory performance. Examples of matrix-specific QC include: Matrix Spike (MS), Matrix Spike Duplicate (MSD), sample duplicates, and surrogate spikes. Additional Info: V1M4: 1.7.3.3
110. Sample Specific Controls
The laboratory shall have procedures in place for tracking, managing, and handling matrix-specific QC criteria, including: --spiking appropriate components at appropriate concentrations, --calculating recoveries and relative percent difference, --evaluating and reporting results based on performance of the QC samples.
Details:
V1M4: 1.7.3.3
111. Matrix Spike; Matrix Spike Duplicates
The frequency of the analysis of matrix spikes are as specified by the method or may be determined as part of the contract review process.
Details:
Matrix-specific QC samples indicate the effect of the sample matrix on the precision and accuracy of the results generated using the selected method. The information from these controls is sample/matrix specific and would not normally be used to determine the validity of the entire batch. Additional Info: 1.7.3.3.1.b
112. Matrix Spike; Matrix Spike Duplicates
The components to be spiked shall be as specified by the mandated method. Any permit specified analytes, as specified by regulation or client requested analytes, shall also be included.
Details:
1.7.3.3.1.c
113. Matrix Spike; Matrix Spike Duplicates
If there are no specified components, the laboratory shall spike per the following: For those components that interfere with an accurate assessment such as spiking simultaneously with technical chlordane, toxaphene and PCBs, the spike shall be chosen that represents the chemistries and elution patterns of the components to be reported.
Details:
1.7.3.3.1.c
114. Matrix Spike; Matrix Spike Duplicates
If there are no specified components, the laboratory shall spike per the following: For those methods that have extremely long lists of analytes, a representative number may be chosen using the following criteria for choosing the number of analytes to be spiked. However, the laboratory shall insure that all targeted components are included in the spike mixture over a two (2) year period. i) For methods that include one (1) to ten (10) targets, spike all components. ii) For methods that include eleven (11) to twenty (20) targets, spike at least ten (10) or 80%, whichever is greater. iii) For methods with more than twenty (20) targets, spike at least sixteen (16) components.
Details:
1.7.3.3.1.c
115. Matrix Spike; Matrix Spike Duplicates
The laboratory shall document the calculation for %R, RPD or other statistical treatment used.
Details:
The results from matrix spike/matrix spike duplicate are primarily designed to assess the precision and accuracy of analytical results in a given matrix and are expressed as percent recovery (%R), relative percent difference (RPD), or other appropriate statistical technique that allows comparison to established acceptance criteria. Additional Info: V1M4: 1.7.4.3.a
116. Matrix Spike; Matrix Spike Duplicates
The results are compared to the acceptance criteria as published in the mandated method.
Details:
V1M4: 1.7.4.3.a
117. Matrix Spike; Matrix Spike Duplicates
Where there are no established criteria, the laboratory shall determine internal criteria and document the method used to establish the limits.
Details:
V1M4: 1.7.4.3.a
118. Matrix Spike; Matrix Spike Duplicates
For matrix spike results outside established criteria, corrective action shall be documented or the data for that sample reported with appropriate data qualifying codes.
Details:
V1M4: 1.7.4.3.a
119. Matrix Duplicates
The frequency of the analysis of matrix duplicates are as specified by the method or may be determined as part of the contract review process.
Details:
Matrix duplicates are defined as replicate aliquots of the same sample taken through the entire analytical procedure. The results from this analysis indicate the precision of the results for the specific sample using the selected method. The matrix duplicate may provide a usable measure of sample homogeneity. It may also provide a measure of precision when target analytes are present. Additional Info: V1M4: 1.7.3.3.2.b
120. Matrix Duplicates
Matrix duplicates are performed on replicate aliquots of actual samples. The composition is usually not known.
Details:
The results from matrix duplicates are primarily designed to assess the homogeneity of the particular sample chosen. If that sample is homogenous it may also describe the precision of analytical results in a given matrix. These may be expressed as relative percent difference (RPD) or another statistical treatment (e.g., absolute differences). Additional Info: V1M4: 1.7.3.3.2.c
121. Matrix Duplicates
The laboratory shall document the calculation for relative percent difference or other statistical treatments.
Details:
V1M4: 1.7.3.3.2.b
122. Matrix Duplicates
Results are compared to the acceptance criteria as published in the mandated method.
Details:
V1M4: 1.7.3.3.2.b
123. Matrix Duplicates
Where there are no established criteria, the laboratory shall determine internal criteria and document the method used to establish the limits.
Details:
V1M4: 1.7.3.3.2.b
124. Matrix Duplicates
For matrix duplicates results outside established criteria, corrective action shall be documented or the data for that sample reported with appropriate data qualifying codes.
Details:
V1M4: 1.7.3.3.2.b
125. Surrogate Spikes
Except where the matrix precludes its use or when not commercially available, surrogate compounds shall be added to all samples, standards, and blanks for all appropriate methods.
Details:
Surrogate compounds are chosen to represent the various chemistries of the target analytes in the method. They are often specified by the mandated method and are deliberately chosen for their being unlikely to occur as an environmental contaminant. Often this is accomplished by using deuterated analogs of select compounds. Additional Info: V1M4: 1.7.3.3.3.b
126. Surrogate Spikes
The results are compared to the acceptance criteria as published in the mandated method.
Details:
V1M4: 1.7.3.3.3.c
127. Surrogate Spikes
Where there are no established criteria, the laboratory shall determine internal criteria and document the method used to establish the limits.
Details:
V1M4: 1.7.4.3.c
128. Surrogate Spikes
Surrogates outside the acceptance criteria shall be evaluated for the effect indicated for the individual sample results. The appropriate corrective action may be guided by the data quality objectives or other site-specific requirements.
Details:
V1M4: 1.7.4.3.c
129. Surrogate Spikes
Results reported from analyses with surrogate recoveries outside the acceptance criteria shall include appropriate data qualifiers.
Details:
V1M4: 1.7.4.3.c
130. Data Reduction
The procedures for data reduction, such as use of linear regression, shall be documented.
Details:
V1M4: 1.7.3.4
131. Reagent Quality, Water Quality and Checks
In methods where the purity of reagents is not specified, analytical reagent grade shall be used.
Details:
V1M4: 1.7.3.5.a
132. Reagent Quality, Water Quality and Checks
Reagents of lesser purity than those specified by the method shall not be used.
Details:
V1M4: 1.7.3.5.a
133. Reagent Quality, Water Quality and Checks
Documentation of purity shall be available.
Details:
V1M4: 1.7.3.5.a
134. Reagent Quality, Water Quality and Checks
The quality of water sources shall be monitored and documented and shall meet method specified requirements.
Details:
V1M4: 1.7.3.5.b
135. Reagent Quality, Water Quality and Checks
The laboratory shall verify the concentration of titrants in accordance with written laboratory procedures.
Details:
V1M4: 1.7.3.5.c
136. Selectivity
The laboratory shall document selectivity by following the checks established within the method.
Details:
V1M4: 1.7.3.6
137. Sample Handling
Samples that are delivered to the laboratory on the same day they are collected may not meet the requirements of Section 1.7.5.a. In these cases, the samples shall be considered acceptable if the samples were received on ice.
Details:
All samples that require thermal preservation shall be considered acceptable if the arrival temperature of a representative sample container is either within 2°C of the required temperature or the method specified range. For samples with a specified temperature of 4°C, samples with a temperature ranging from just above the freezing temperature of water to 6°C shall be acceptable. Additional Info: V1M4: 1.7.5.a.i
138. Sample Handling
If sample analysis is begun within fifteen (15) minutes of collection, thermal preservation is not required.
Details:
All samples that require thermal preservation shall be considered acceptable if the arrival temperature of a representative sample container is either within 2°C of the required temperature or the method specified range. For samples with a specified temperature of 4°C, samples with a temperature ranging from just above the freezing temperature of water to 6°C shall be acceptable. Additional Info: V1M4: 1.7.5.a.iii
139. Sample Handling
Thermal preservation is not required in the field if the laboratory receives and refrigerates the sample within fifteen (15) minutes of collection.
Details:
All samples that require thermal preservation shall be considered acceptable if the arrival temperature of a representative sample container is either within 2°C of the required temperature or the method specified range. For samples with a specified temperature of 4°C, samples with a temperature ranging from just above the freezing temperature of water to 6°C shall be acceptable. Additional Info: V1M4: 1.7.5.a.iii
140. Sample Handling
The laboratory shall implement procedures for checking sample preservation using readily available techniques, such as pH or chlorine, prior to or during sample preparation or analysis.
Details:
V1M4: 1.7.5.b
141. Sample Handling
An exception is allowed for volatile organic compound analyses; chemical preservation may be checked after analysis.
Details:
V1M4: 1.7.5.b
V1M5 Microbiological Testing
1. Method Selection
When it is necessary to use methods not covered by reference methods, these shall be subject to agreement with the client and shall include a clear specification of the client's requirements and the purpose of the environmental test.
Details:
V1M5: 1.4
2. Method Selection
The method developed shall have been validated appropriately before use.
Details:
V1M5: 1.4
3. Method Validation
The laboratory shall validate non-reference methods, laboratory-designed/developed methods, reference methods used outside their published scope, and amplifications and modifications of reference methods to confirm that the methods are fit for the intended use.
Details:
V1M5: 1.5
4. Method Validation
The validation shall be as extensive as is necessary to meet the needs of the given application or field of application.
Details:
V1M5: 1.5
5. Method Validation
The laboratory shall record the results obtained, the procedure used for the validation, and a statement as to whether the method is fit for the intended use. The minimum requirements for method validation are given in Sections 1.5.1, 1.5.2 and 1.5.3.
Details:
V1M5: 1.5
6. Method Validation
The laboratory shall maintain documentation of the validation procedure for as long as the method is in use and for at least five (5) years past the date of last use.
Details:
V1M5: 1.5
7. Method Validation
Laboratories shall participate in a proficiency test program when available. The results of these analyses shall be used to evaluate the ability of the laboratory to produce acceptable data.
Details:
V1M5: 1.5
8. Method Validation
Accuracy – Use at least one (1) known pure reference culture at the anticipated environmental conditions, and compare the method results to that of a reference method.
Details:
The following assessment shall be performed. If no reference method exists, or if the data quality objectives are different from the reference method, then the laboratory shall demonstrate that the method meets the quality objectives for the intended use. Additional Info: V1M5: 1.5.1
9. Method Validation
Precision – Perform at least ten (10) replicate analyses with both the proposed and reference method, using the target microorganisms of choice. The results shall show that the methods are not statistically different.
Details:
The following assessment shall be performed. If no reference method exists, or if the data quality objectives are different from the reference method, then the laboratory shall demonstrate that the method meets the quality objectives for the intended use. Additional Info: V1M5: 1.5.2
10. Method Validation
Selectivity (sensitivity) – Verify all responses in at least ten (10) samples using mixed cultures that include the target organism(s), and at varying concentrations (microbial identification testing or equivalent processes may be used). Calculate the number of false positive and false negative results
Details:
The following assessment shall be performed. If no reference method exists, or if the data quality objectives are different from the reference method, then the laboratory shall demonstrate that the method meets the quality objectives for the intended use. Additional Info: V1M5: 1.5.3
11. Demonstration of Capability (DOC)
Prior to acceptance and institution of any method for data reporting, satisfactory initial DOC is required.
Details:
V1M5: 1.6.1
12. Demonstration of Capability (DOC)
Thereafter, ongoing DOC (Section 1.6.3), as per the quality control requirements in Section 1.7.3, is required.
Details:
V1M5: 1.6.1
13. Demonstration of Capability (DOC)
In cases where a laboratory analyzes samples using a method that has been in use by the laboratory for at least one year prior to applying for accreditation, and there have been no significant changes in instrument type, personnel or method, the ongoing DOC shall be acceptable as an initial DOC.
Details:
V1M5: 1.6.1
14. Demonstration of Capability (DOC)
The laboratory shall have records on file to demonstrate that an initial DOC is not required.
Details:
V1M5: 1.6.1
15. Demonstration of Capability (DOC)
For the initial DOC, appropriate records as discussed in Section 1.6.2 shall be completed.
Details:
V1M5: 1.6.1
16. Demonstration of Capability (DOC)
An initial DOC shall be completed each time there is a change in instrument type, personnel, or method.
Details:
V1M5: 1.6.1
17. Demonstration of Capability (DOC)
All demonstrations shall be documented.
Details:
V1M5: 1.6.1
18. Demonstration of Capability (DOC)
All data applicable to the demonstration shall be retained and readily available at the laboratory.
Details:
V1M5: 1.6.1
19. Initial DOC
An initial DOC shall be made prior to using any method,
Details:
V1M5: 1.6.2
20. Initial DOC
An initial DOC shall be at any time there is a change in instrument type, personnel or method
Details:
V1M5: 1.6.2
21. Initial DOC
An initial DOC shall be made any time that a method has not been performed by the laboratory or analyst in a twelve (12) month period.
Details:
V1M5: 1.6.2
22. Initial DOC
The laboratory shall document each initial DOC in a manner such that the following information is readily available for each affected employee: a) analyst(s) involved in preparation and/or analysis; b) matrix; c) organism(s); d) identification of method(s) performed; e) identification of laboratory-specific SOP used for analysis, including revision number; f) date(s) of analysis; g) summary of analyses, including information outlined in Section 1.6.2.2.c.
Details:
V1M5: 1.6.2.1
23. Initial DOC
If the method or regulation does not specify an initial DOC, the following procedure is acceptable. It is the responsibility of the laboratory to document that other approaches to initial DOC are adequate.
Details:
V1M5: 1.6.2.2
24. Initial DOC
The target organism(s) shall be diluted in a volume of clean quality system matrix (a sample in which no target organisms or interferences are present at concentrations that will impact the results of a specific method).
Details:
V1M5: 1.6.2.2.a
25. Initial DOC
This matrix shall be sterile phosphate or sterile peptone solution unless specified by the manufacturer.
Details:
V1M5: 1.6.2.2.a
26. Initial DOC
Prepare at least four (4) aliquots at the concentration specified, or if unspecified, to the countable range for plate methods or working range for most probable number (MPN) type methods.
Details:
V1M5: 1.6.2.2.a
27. Initial DOC
At least four (4) aliquots shall be prepared and analyzed according to the method either concurrently or over a period of days.
Details:
V1M5: 1.6.2.2.b
28. Initial DOC
Using all of the results, convert these results to logarithmic values, then calculate the mean recovery and standard deviation of the log converted results in the appropriate reporting units for each organism of interest.
Details:
V1M5: 1.6.2.2.c
29. Initial DOC
When it is not possible to determine mean and standard deviations, such as for presence/absence, the laboratory shall assess performance against established and documented criteria.
Details:
V1M5: 1.6.2.2.c
30. Initial DOC
For qualitative tests, acceptable performance in a blind study, either internally or externally generated, may be used to meet this Standard, provided that the study consists of a minimum of a: --blank, --negative culture, and --positive culture for each target organism or metabolite (e.g. b-glucuronidase in E. coli.).
Details:
V1M5: 1.6.2.2.d
31. Initial DOC
Compare the information from c) above (requirement 756) to the corresponding acceptance criteria for precision and accuracy in the method (if applicable or in laboratory-generated acceptance criteria (if there are not established mandatory criteria). If all parameters meet the acceptance criteria, the analysis of actual samples may begin. If any one of the parameters does not meet the acceptance criteria, the performance is unacceptable for that parameter.
Details:
V1M5: 1.6.2.2.e
32. Initial DOC
When one or more of the tested parameters fail at least one of the acceptance criteria, the analyst shall proceed according to i) or ii) below. i) Locate and correct the source of the problem and repeat the initial DOC for all parameters of interest beginning with b) (requirement 755) above. ii) Repeat the initial DOC for all parameters that failed to meet criteria.
Details:
V1M5: 1.6.2.2.f
33. Initial DOC
Repeated failure, however, confirms a general problem with the measurement system. If this occurs, locate and correct the source of the problem and repeat the test for all compounds of interest beginning with b) (requirement 755).
Details:
V1M5: 1.6.2.2.g
34. Ongoing DOC
The laboratory shall have a documented procedure describing ongoing DOC.
Details:
V1M5: 1.6.3.1
35. Ongoing DOC
The analyst(s) shall demonstrate ongoing capability by meeting the quality control requirements of the method, laboratory SOP, client specifications, and/or this Standard.
Details:
V1M5: 1.6.3.1
36. Ongoing DOC
This ongoing demonstration may include one of the following or by performing another initial DOC. a) Analysis of one sample or clean matrix that is fortified with a known quantity of the target organism, with results meeting the laboratory acceptance criteria for accuracy and, where applicable to the testing technique, also meeting the observational details expected for the presumptive, confirmed and completed phases defined in the method. b) Analysis of one sample in duplicate for each target organism and test, with results meeting the laboratory acceptance criterion for precision. c) Acceptable results for one-single-blind proficiency test sample for target organisms in each field of accreditation. d) Performance of an alternate adequate procedure for the field of accreditation, the procedure and acceptance criteria being documented in the laboratory’s quality system. e) A documented process of analyst review using QC samples. QC samples can be reviewed to identify patterns for individuals or groups of analysts and determine if corrective action or retraining is necessary; or f) If a) through e) are not technically feasible, then analysis of real-world samples with results within a predefined acceptance criteria (as defined by the laboratory or method) shall be performed.
Details:
V1M5: 1.6.3.2
37. Technical Requirements - Calibration
The laboratory shall have documented procedures for calibration, verification, and quality control of support equipment including conductivity meters, oxygen meters, pH meters, hygrometers, and other similar measurement instruments.
Details:
V1M5: 1.7.1.a
38. Technical Requirements - Calibration
The laboratory shall document acceptable calibration verification at least once a month.
Details:
For instruments that are continuous monitors, such as in-line specif