The NELAC Institute Consensus Standards Development ProgramKenneth W. Jackson

NY State Dept. of HealthWadsworth Center, Albany NY

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

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.

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

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

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

Goal of the Consensus Standards Development

ProgramTo 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

Application for ANSI Accreditation as a Consensus Standards

Development BodyTNI had to demonstrate:

Openness Balance of interest Consensus Due Process Appeals Process

This was achieved through submission to ANSI of:

1.Policies Governing Standards Development2.Procedures for Expert Committee Operations3.TNI Bylaws

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

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

ANSI Requirements of a Consensus Standards

Development Body Openness Balance of interest Consensus

General, but not necessarily universal agreement

Due Process Appeals Process

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

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.

Standards Development Process

1. Expert Committees submit Working Draft Standard (WDS) for public comment.

2. WDS is modified to become Draft Interim Standard (DIS).

3. All TNI members may vote on DIS.4. DIS modified as a result of persuasive

comments received.5. If modified DIS passes, it becomes

Interim Standard (IS).6. All TNI members may vote on IS.7. If IS passes, it becomes the Final

Standard (FS).

Status of the TNI StandardsEnvironmental Sector (Red = Interim; Black = Final Standard)

Volume 1: Laboratory Requirements

Module 1 – Proficiency testingModule 2 – Quality Systems: General RequirementsModules 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 RequirementsModule 2 – Proficiency TestingModule 3 – On-Site Assessment

Volume 3: Proficiency Testing Provider RequirementsVolume 4: Proficiency Testing Oversight

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

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)

Modified Standards Development Process

1. Expert Committees submit Working Draft Standard (WDS) for public comment.

2. WDS is modified to become Draft Interim Standard (DIS).

3. All TNI members may vote on DIS.4. DIS modified as a result of persuasive

comments received.5. If modified DIS passes, it becomes

Interim Final Standard.6. All TNI members may vote on IS.7. If IS passes, it becomes the Final

Standard (FS).

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.

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.