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The NELAC Institute Consensus Standards Development Program. Kenneth W. Jackson. 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 - PowerPoint PPT Presentation
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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
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
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
ANSI Requirements of a Consensus Standards
Development Body Openness Balance of interest Consensus Due Process Appeals Process
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, 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
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
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.
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
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
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
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)
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
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
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
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.
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)
Standards Development Process
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
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
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
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
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
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
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