The NELAC Institute Consensus Standards Development Program

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The NELAC Institute Consensus Standards
Development Program

• Kenneth W. Jackson

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Todays 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

3
Todays 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

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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

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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.
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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

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Todays 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

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ANSI Requirements of a Consensus Standards
Development Body

• Openness
• Balance of interest
• Consensus
• Due Process
• Appeals Process

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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

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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

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ANSI Requirements of a Consensus Standards
Development Body

• Openness
• Balance of interest
• Consensus
• General, but not necessarily universal agreement
• Due Process
• Appeals Process

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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

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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.

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Todays 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

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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.

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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

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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

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Todays 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

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Areas of Standards Development

• Accreditation of Environmental Laboratories
  (Environmental Sector)

• 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

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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

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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

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Todays 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

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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.

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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)

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Standards Development ProcessTentative 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 comment
4. The Expert Committee must vote to accept the TIA
5. The TIA can remain for only 2 years. It must
   then go through the normal standards development
   process

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Todays 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

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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

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TNI StandardsEnvironmental 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

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TNI StandardsEnvironmental 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

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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

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

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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
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TNI Standards
Stationary Source Audit Sample Standard

• The TNI membership recently voted on the
  committees 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

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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 (V2M1V2M3)
  and ISO 17025 (V1M2 and FSMO volumes) included
  are available for purchase from TNI. Non-ISO
  versions can be downloaded at no cost.

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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