The NELAC Institute Consensus Standards Development Program

1. The NELAC Institute Consensus Standards Development Program Kenneth W. Jackson NY State Dept. of Health Wadsworth Center, Albany NY

2. 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

3. 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.

4. Consensus Standards Development Program Board • JoAnn Boyd (member-at-large) • Bob DiRienzo (Quality Systems Committee Chair) • Jeff Flowers (Accreditation Body Committee Chair) • Ken Jackson (Board Chair) • Anand Mudambi (Proficiency Testing Committee Chair) • Denise Rice (On-Site Assessment Committee Chair) • Dave Speis (Field Activities Committee Chair – pro tem) • TNI staff: Jane Wilson

5. Consensus Standards Development Program The CSDP Board has oversight of the following committees: • Proficiency Testing Expert Committee • On-Site Assessment Expert Committee • Quality Systems Expert Committee • Accreditation Body Expert Committee • Field Activities Expert Committee • Uniformity of Standards Committee

6. 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

7. Goal of the Consensus Standards Development Program To develop standards for accreditation of laboratories by accreditation bodies • Standards for: laboratories (includes sampling and field measurement organizations); accreditation bodies; PT providers; PT provider oversight bodies • Standards based on ISO 17011 and ISO 17025 where applicable • Standards are developed through an open consensus process, involving all stakeholders

8. Application for ANSI Accreditation as a Consensus Standards Development Body TNI had to demonstrate: • Openness • Balance of interest • Consensus • Due Process • Appeals Process • This was achieved through submission to ANSI of: • Policies Governing Standards Development • Procedures for Expert Committee Operations • TNI Bylaws

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; and c) others (consultants, PT providers, non-accredited labs, 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. Application for 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. Standards Development Process • Expert Committees submit Working Draft Standard (WDS) for public comment. • WDS is modified to become Draft Interim Standard (DIS). • All TNI members may vote on DIS. • DIS modified as a result of persuasive comments received. • If modified DIS passes, it becomes Interim Standard (IS). • All TNI members may vote on IS. • If IS passes, it becomes the Final Standard (FS).

15. Status of the TNI Standards Environmental Sector (Red = Interim; Black = Final Standard) Volume 1: Laboratory Requirements Module 1 – Proficiency testing Module 2 – Quality Systems: General Requirements Modules 3 – 7 are QS requirements for: Asbestos Testing (3); Chemical Testing (4); Microbiological Testing (5); Radiochemical Testing (6); and Toxicity Testing (7) Volume 2: Accreditation Body requirements Module 1 – General Requirements Module 2 – Proficiency Testing Module 3 – On-Site Assessment Volume 3: Proficiency Testing Provider Requirements Volume 4: Proficiency Testing Oversight

16. Status of the TNI Standards Field Sampling and Measurement Organization Sector (Final Standard) Volume 1: General Requirements for Field Sampling and Measurement Organizations Volume 2: General Requirements for Accreditation Bodies Accrediting Field Sampling and Measurement Organizations

17. Modified Standards Development Process • ANSI objected to the Final Standard vote: • Vote by entire membership is not a consensus vote, since balance is not achieved, and it is just a “yes/no” vote. • This would open the door for any special interest group to dominate the voting process.(Only 79 members voted on the previous Final Standard)

18. Modified Standards Development Process • Expert Committees submit Working Draft Standard (WDS) for public comment. • WDS is modified to become Draft Interim Standard (DIS). • All TNI members may vote on DIS. • DIS modified as a result of persuasive comments received. • If modified DIS passes, it becomes Interim Final Standard. • All TNI members may vote on IS. • If IS passes, it becomes the Final Standard (FS).

19. TNI Accreditation StandardsAvailability • Environmental Sector:A complete set of standards is now available • Field Sampling and Measurement Organization Sector:General Requirements Standards are 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.

20. 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. • This week: The PT and QS committees will present their standards and responses to comments received during the recent vote. • The CSDB will continue to develop new and improved standards as requested.