The NELAC Institute Consensus Standards Development Program

The NELAC Institute Consensus Standards Development ProgramKenneth W. Jackson

Today’s Presentation

1. What is the Consensus Standards Development Program (CSDP)?

2. How does the CSDP operate?

3. Membership of the CSDP

4. Areas of standards development

5. The standards development process

6. The TNI standards

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.

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

ANSI Requirements of a Consensus Standards

Development Body Openness Balance of interest Consensus Due Process Appeals Process


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


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


Development Body Openness Balance of interest Consensus

General, but not necessarily universal agreement

Due Process Appeals Process


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

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.

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.

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

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

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)


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


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

Standards Development Process

1. Expert Committee (EC) develops a Working Draft Standard (WDS).

2. WDS discussed publicly at TNI semi-annual meeting.

3. EC modifies the WDS as a result of comments received. Becomes the Voting Draft Standard (VDS).

4. VDS presented for electronic vote.5. All written comments received with the votes are

discussed at TNI semi-annual meeting.6. EC resolves all persuasive comments, modifying

the VDS.7. VDS becomes the TNI Standard.


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)


Tentative Interim Amendments (TIA)

1. Request can be submitted by anyone, but most likely to come from LASC

2. CSDB must determine it is “of an emergency nature”

3. Must be submitted for public comment4. The Expert Committee must vote to

accept the TIA5. The TIA can remain for only 2 years. It

must then go through the normal standards development process

TNI StandardsEnvironmental 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



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 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






This has been passed as a TNI Standard, and has been offered to NELAP for adoption

TNI StandardsField 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

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

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.

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

The NELAC Institute Consensus Standards Development Program

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