1. The NELAC Institute Consensus Standards Development Program Kenneth W. Jackson

2. Today’s Presentation  What is the Consensus Standards Development Program (CSDP)?  How does the CSDP operate?  Membership of the CSDP  Areas of standards development  The standards development process  The TNI standards

3. Today’s Presentation  What is the Consensus Standards Development Program (CSDP)?  How does the CSDP operate?  Membership of the CSDP  Areas of standards development  The standards development process  The TNI standards

4. Programs of TNI  Core Programs  Consensus Standards Development  Laboratory Accreditation System  National Environmental Laboratory Accreditation  Proficiency Testing  Program Support  Policy Development  Advocacy  Administration  Technical Assistance

5. TNI Bylaws, Section 1 (D) Consensus Standards Development Program The purpose of the Consensus Standards Development Program (CSDP) is to develop standards [for the accreditation of environmental laboratories]. The Consensus Standards Development Program Board is responsible for managing this program. The CSDP Board consists of the Chair of each Expert Committee plus additional at-large members representing other stakeholder interests. This core program has a support role in assisting the LASP Committee in developing the laboratory accreditation system.

6. Goal of the Consensus Standards Development Program  To develop standards through an open consensus process, involving all stakeholders  To base standards on applicable ISO standards; e.g., ISO 17011 and ISO 17025

7. Today’s Presentation  What is the Consensus Standards Development Program (CSDP)?  How does the CSDP operate?  Membership of the CSDP  Areas of standards development  The standards development process  The TNI standards

8. ANSI Requirements of a Consensus Standards Development Body  Openness  Balance of interest  Consensus  Due Process  Appeals Process

9. ANSI Requirements of a Consensus Standards Development Body  Openness  Committee membership open to all  All meetings open to all members  Minutes of all meetings are posted  The public may provide input  Balance of interest  Consensus  Due Process  Appeals Process

10. ANSI Requirements of a Consensus Standards Development Body  Openness  Balance of interest  No single interest category can constitute a majority of committee members on any committee. Interest categories are: a) accreditation bodies; b) accredited laboratories, including sampling and field measurement organizations; and c) others (consultants, PT providers, state and fed agencies that do not run accreditation programs, etc.)  Consensus  Due Process  Appeals Process

11. ANSI Requirements of a Consensus Standards Development Body  Openness  Balance of interest  Consensus  General, but not necessarily universal agreement  Due Process  Appeals Process

12. ANSI Requirements of a Consensus Standards Development Body  Openness  Balance of interest  Consensus  Due Process  Any person with a direct and material interest has a right to participate by: a) expressing a position and its basis; b) having that position considered; and c) having the right to appeal  Appeals Process

13. ANSI Accreditation as a Consensus Standards Development Body Having met all requirements, the TNI Consensus Standards Development Program was approved by ANSI, effective December 18, 2007.

14. Today’s Presentation  What is the Consensus Standards Development Program (CSDP)?  How does the CSDP operate?  Membership of the CSDP  Areas of standards development  The standards development process  The TNI standards

15. Consensus Standards Development Program Membership  The Consensus Standards Development Program (CSDP) consists of Expert Committees that develop the standards  The CSDP Board consists of the chair of every Expert Committee and members-at-large.

16. Consensus Standards Development Program Board  Joe Aiello (Accreditation Body Committee Chair)  JoAnn Boyd (Member-at-large)  Maria Friedman (Stationary Source Audit Sample Committee Chair)  Ken Jackson (Member-at-large)  Paul Junio (Quality Systems Committee Chair)  Kirstin McCracken (Proficiency Testing Committee Chair)  Denise Rice (On-Site Assessment Committee Chair)  Marlene Moore (Field Activities Committee Chair)  Bob Wyeth (Board Chair; Member-at-large)  TNI staff: Jane Wilson

17. Expert Committee Membership Committee Members  5-15 on each committee  Appointed to maintain balance  Votes are tallied for passage or failure of a voting item  Votes with comments must be brought to resolution for passage of a voting item Associate Committee Members  All TNI members and affiliates can be Associate Committee Members on any/all committees  Votes with comments must be brought to resolution for passage of a voting item

18. Today’s Presentation  What is the Consensus Standards Development Program (CSDP)?  How does the CSDP operate?  Membership of the CSDP  Areas of standards development  The standards development process  The TNI standards

19. Areas of Standards Development  Standards for: laboratories; accreditation bodies; PT providers; PT provider accreditors  Expert Committees: Proficiency Testing Expert Committee; On-Site Assessment Expert Committee; Quality Systems Expert Committee; Accreditation Body Expert Committee Accreditation of Environmental Laboratories (Environmental Sector)

20. Areas of Standards Development Accreditation of Field Sampling and Measurement Organizations (Field Sampling and Measurement Organization Sector)  Standards for: field sampling and measurement organizations; accreditation bodies;  Expert Committee: Field Activities Expert Committee

21. Areas of Standards Development Stationary Source Audit Samples  Standards for: manufacture (and analysis) of air audit samples for source emission testing.  Expert Committee: Stationary Source Audit Sample Expert Committee

22. Today’s Presentation  What is the Consensus Standards Development Program (CSDP)?  How does the CSDP operate?  Membership of the CSDP  Areas of standards development  The standards development process  The TNI standards

23. Standards Development Process  Expert Committee (EC) develops a Working Draft Standard (WDS).  WDS discussed publicly at TNI semi-annual meeting.  EC modifies the WDS as a result of comments received. Becomes the Voting Draft Standard (VDS).  VDS presented for electronic vote.  All written comments received with the votes are discussed at TNI semi-annual meeting.  EC resolves all persuasive comments, modifying the VDS.  VDS becomes the TNI Standard.

24. Standards Development Process The Environmental Sector Standard has undergone further changes. The TNI Laboratory Accreditation System Committee (LASC) reviewed the TNI Standard for its suitability for adoption by the National Environmental Laboratory Accreditation Program (NELAP) Changes and amendments:  Editorial changes  Tentative Interim Amendments (TIA)

25. Standards Development Process Tentative Interim Amendments (TIA)  Request can be submitted by anyone, but most likely to come from LASC  CSDB must determine it is “of an emergency nature”  Must be submitted for public comment  The Expert Committee must vote to accept the TIA  The TIA can remain for only 2 years. It must then go through the normal standards development process

26. Today’s Presentation  What is the Consensus Standards Development Program (CSDP)?  How does the CSDP operate?  Membership of the CSDP  Areas of standards development  The standards development process  The TNI standards

27. TNI Standards Environmental Sector  Volume 1 - Management and Technical Requirements for Laboratories Performing Environmental Analysis  Volume 2 - General Requirements for Accreditation Bodies Accrediting Environmental Laboratories  Volume 3 - General Requirements for Environmental Proficiency Test Providers  Volume 4 - General Requirements for an Accreditor of Environmental Proficiency Test Providers

28. TNI Standards Environmental Sector  Volume 1 - Management and Technical Requirements for Laboratories Performing Environmental Analysis  Module 1: Proficiency Testing  Module 2: Quality Systems General Requirements  Module 3: Quality Systems for Asbestos Testing  Module 4: Quality Systems for Chemical Testing  Module 5: Quality Systems for Microbiological Testing  Module 6: Quality Systems for Radiochemical Testing  Module 7: Quality Systems for Toxicity Testing  Volume 2 - General Requirements for Accreditation Bodies Accrediting Environmental Laboratories  Volume 3 - General Requirements for Environmental Proficiency Test Providers  Volume 4 - General Requirements for an Accreditor of Environmental Proficiency Test Providers

29. TNI Standards Environmental Sector  Volume 1 - Management and Technical Requirements for Laboratories Performing Environmental Analysis  Volume 2 – General Requirements for Accreditation Bodies Accrediting Environmental Laboratories  Module 1: General Requirements  Module 2: Proficiency Testing  Module 3 : On-Site Assessment  Volume 3 – General Requirements for Environmental Proficiency Test Providers  Volume 4 – General Requirements for an Accreditor of Environmental Proficiency Test Providers

30. TNI Standards Environmental Sector  Volume 1 - Management and Technical Requirements for Laboratories Performing Environmental Analysis  Volume 2 - General Requirements for Accreditation Bodies Accrediting Environmental Laboratories  Volume 3 - General Requirements for Environmental Proficiency Test Providers  Volume 4 - General Requirements for an Accreditor of Environmental Proficiency Test Providers This has been passed as a TNI Standard, and has been offered to NELAP for adoption

31. TNI Standards Field Sampling and Measurement Organization Sector  Volume 1 - General Requirements for Field Sampling and Measurement Organizations  Volume 2 – General Requirements for Accreditation Bodies Accrediting Field Sampling and Measurement Organizations This has been passed as a TNI Standard

32. TNI Standards The TNI membership recently voted on the committee’s Voting Draft Standard. The comments received during the voting process will be discussed this week. The committee will then incorporate changes as a result of the persuasive comments and will produce the TNI Final Standard Stationary Source Audit Sample Standard

33. TNI Standards Availability  Environmental Sector: A complete set of standards is now available  Field Sampling and Measurement Organization Sector: A complete set of standards is now available  The Final Standards will be offered to interested organizations, including the TNI NELAP Board  The Final Standards with ISO 17011 (V2M1;V2M3) and ISO 17025 (V1M2 and FSMO volumes) included are available for purchase from TNI. Non-ISO versions can be downloaded at no cost.

34. Summary  The TNI Consensus Standards Development Program develops standards though an open consensus process  The standards are based on relevant ISO standards where applicable  These standards are then offered to the TNI NELAP, and are available to any other interested organization  The Environmental Sector standard is complete  The Field Sampling and Measurement Organization sector standard is complete  The Stationary Source Audit Sample standard is under preparation  The CSDB will continue to develop new and improved standards as requested