The Standards adopted by the National Environmental Laboratory Accreditation Conference (NELAC) in 2003 are the current standards that are used by TNI accreditation bodies for the accreditation of environmental laboratories, and will continue to be the applicable standards until the new TNI standards have been implemented. Implementation is scheduled to occur on July 1, 2011.

2003 NELAC STANDARD

TNI has established an avenue for resolution of questions submitted electronically on interpretation of the 2003 NELAC Standard. Click here to view responses to requests that were previously submitted. Click here to submit a new request.

Accreditation standards are developed by Expert Committees using a consensus process that includes the elements of openness, balance, due process, and consensus as established by Circular A-119 published by the US Office of Management and Budget.

On August 24, 2009, the National Environmental Laboratory Accreditation Program (NELAP) Board adopted the following TNI standards for use in the state recognized laboratory accreditation programs.  By separate vote, the NELAP Board established July 1, 2011, as the official implementation date.  The July 1, 2011, implementation date allows state accreditation bodies sufficient time to change state regulations to reflect the new standards, as well as allowing laboratories time to come into compliance with the new standards. Prior to implementing the new standards, the NELAP Board will be working with other TNI committees to ensure that all policies, checklists and SOPs needed for implementation of the new standards are in place for the state accreditation bodies.

The accreditation standards below are freely available for download. However, it is important to note that some modules contain language from ISO/IEC 17025 and 17011. Because of copyright restrictions, the publicly available TNI documents do not contain the ISO/IEC copyright protected language, but do reference applicable ISO clauses. In these situations, it is useful to read the TNI Standard along with the ISOI/IEC standard. Wherever an ISO clause is referenced (in italics), the language from that clause is applicable. Any additional TNI language then follows, in plain text, as a NOTE or as an additional numbered standard item. TNI has produced a version of these standards where the ISO/IEC language is combined with the TNI language. These combined documents are available for prices that essentially recover the cost of the license agreements for use of the ISO/IEC language. To purchase these integrated documents, click on Sale of TNI Standards below.

Environmental Laboratory Sector

Volume 1: Management and Technical Requirements for Laboratories Performing Environmental Analysis

Module 1 - Proficiency Testing

Module 2 - Quality Systems: General Requirements 1

Module 3 - Asbestos Testing

Module 4 - Chemical Testing

Module 5 - Microbiological Testing

Module 6 - Radiochemical Testing

Module 7 - Toxicity Testing

Volume 2: General Requirements for Accreditation Bodies Accrediting Environmental Laboratories

Module 1 - General Requirements 2

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

Field Sampling and Measurement Organization (FSMO) Sector

 

Volume 1: General Requirements for Field Sampling and Measurement Organizations 1

Volume 2: General Requirements for Accreditation Bodies Accrediting Field Sampling and Measurement 2

 

Stationary Source Audit Sample Program Sector

Please visit the Stationary Source Audit Sample Program home page at
http://nelac-institute.org/ssas for information about TNI's program and standards.

 

Notes:
1. Contains language from ISO 17025
2. Contains language from ISO 17011

The accreditation standards are freely available for download. However, it is important to note that some modules contain language from ISO/IEC 17025 and 17011. Because of copyright restrictions, the publicly available TNI documents do not contain the ISO/IEC copyright protected language, but do reference applicable ISO clauses. In these situations, it is useful to read the TNI Standard along with the ISOI/IEC standard. Wherever an ISO clause is referenced (in italics), the language from that clause is applicable. Any additional TNI language then follows, in plain text, as a NOTE or as an additional numbered standard item. TNI has produced a version of these standards where the ISO/IEC language is combined with the TNI language. These combined documents are available for prices that essentially recover the cost of the license agreements for use of the ISO/IEC language.

The TNI standards are integrated documents containing language from relevant ISO standards and language developed by TNI expert committees. The purchase of the integrated TNI documents eliminates the need to purchase a separate copy of the relevant ISO/IEC standard.

Any Patron level organizational member of TNI will receive a network version of all of the combined documents as part of their annual membership fee. Any Sponsor organizational member of TNI will receive a network version of Volume 1 and a single copy of Volume 2 as part of their annual membership fee. Individual and Partner level members may purchase copies of the combined standards as shown in the table below.

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Laboratory Accreditation Standards
Volume 1: Management and Technical Requirements for Laboratories Performing Environmental Analysis
Single Use version:$50	Network version: $90
Volume 2: General Requirements for Accreditation Bodies Accrediting Environmental Laboratories
Single Use version:$65	Network version: $75
Field Activities Standards
Volume 1: General Requirements for Field Sampling and Measurement Organizations
Single Use version:$50	Network version: $90
Volume 2: General Requirements for Accreditation Bodies Accrediting Field Sampling and Measurement Organizations
Single Use version:$65	Network version: $75

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1. An organization participating at the Partner level may select one free volume each year.

2. A member (individual or organization) may obtain a network version for additional sites (defined by zip code) for a one time fee of $30 per site for Volume 1 and $75 per site per year for Volume 2.

Note: Anyone who purchases one of the volumes listed above will automatically receive the final version of the standard for no additional charge.

The federal Office of Management and Budget (OMB) Circular A-119 defines a voluntary consensus standards body as one having the following attributes:

(i)openness; (ii) balance of interest; (iii) due process; (iv) an appeals process; and (v) consensus, which is general agreement, but not necessarily unanimity, and includes a process for attempting to resolve objections by interested parties, as long as all comments have been fairly considered, each objector is advised of the disposition of his or her objection(s) and the reason(s) why, and the consensus body members are given an opportunity to change their votes after reviewing the comments.

Standards are developed by the TNI Consensus Standards Development Program (CSDP), in conformance with TNI’s Procedures Governing Standards Development. The American National Standards Institute (ANSI) recently approved the TNI process for standards development indicating that TNI meets the ANSI requirements. This means the TNI standards are developed through an open consensus process in which all members and the public may provide input and have their position considered, preventing dominance by any one group of stakeholders by assuring a balance of interests among the committee members who develop the standards. The Expert Committees (Proficiency Testing; On-Site Assessment; Quality Systems; Accreditation Body; and Field Activities) each develop a Working Draft Standard that is presented to the membership and the public at the TNI Forum on Laboratory Accreditation. As a result of input received during and following that open meeting, the Expert Committees modify their Working Draft Standard to produce the Voting Draft Standard. All TNI members may then vote electronically, providing comments in support of their positive or negative votes. The Expert Committees must allow for public debate on every comment at the next Forum on Laboratory Accreditation. The Expert Committees hold meetings to rule each comment persuasive or non-persuasive and publish a Response to Comments document.

Committees must resolve every persuasive comment, which may require modification of the standard. Some comments may suggest major changes to the standard (e.g., reduce proficiency test frequency to once per year instead of twice per year), and they may be placed on hold until the next standards revision cycle to allow consideration and debate by the membership and the public.

When persuasive comments are resolved and the standard modules are approved by a majority vote of the Committee Members, the standard then becomes final as the TNI Standard.

After a standard has been adopted by an expert committee, it undergoes an editorial review for consistency and then is published on the TNI website. After publication, TNI must allow thirty days for appeals. The standards will be available for adoption and implementation after resolving appeals.

After resolution of appeals, the standard may be used by any organization. However, for use within TNI’s National Environmental Laboratory Accreditation Program (ELAP), the TNI Laboratory Accreditation System Committee (LASC) reviews the adopted TNI Standard and develops supplementary documents (guidance, SOPs, etc.), when needed. The LASC then forwards the standards to the TNI NELAP for this program to adopt the standard for use by all Accreditation Bodies (ABs). TNI expects NELAP ABs will require a lead time of about two years to amend regulations and implement the standard. Because modifying regulations is restrictive and time-consuming, the current NELAP ABs may possibly continue to accredit laboratories to the 2003 NELAC standards until the year 2010, when their proposed regulations are finalized to allow accreditation to the TNI standard.

Posted are the vote tallies and response-to-comments documents, explaining the resolution of all written comments that accompanied the vote on the current standards.

The NELAC Institute (TNI ) Procedures for Expert Committee Operations describe how any TNI member may participate, as an Associate Committee Member, in conference calls of any Expert Committee. The dates/times of scheduled calls are listed on each Expert Committee’s web page as well as on the Event Calendar

In order to participate in any forthcoming conference calls, you should register with the chair of the Expert Committee(s) of interest. You will then receive an invitation to each conference call, together with an abbreviated agenda and any documentation pertinent to the meeting. If you wish to attend, you must so notify the chair at least 24-hours in advance of the meeting. You will then be provided with the call-in number and a telephone line will be made available for you.