The New TNI Laboratory Accreditation Standards

1. The New TNI Laboratory Accreditation Standards Requirements for an Accreditation Body

2. FUNDAMENTAL CONCEPTS • TNI develops consensus standards that are voluntarily adopted by states agencies designated as accreditation bodies (ABs). • TNI’s NELAP Board oversees accreditation bodies to assure uniformity. • State grants accreditation, which is unconditionally recognized, by other participating ABs. • Laboratories can voluntarily apply to any approved NELAP AB, if their home state does not participate.

3. NELAP ABs NELAP Accreditation Body Application Being Processed Working on Program/Application Require Program Recognize Program Incorporated Program Components

4. IMPLEMENTATION • States adopt standards voluntarily: • Select scope of accreditation; • Select voluntary or mandatory nature of program; • Select types of laboratories to be accredited; • May use third party assessors; and • May assess fees. • States must comply with the standards • Accept reciprocity; and • Refrain from adding supplemental requirements.

5. NELAP BOARD • One representative and one alternate from each NELAP-recognized Accreditation Body. • Each representative and alternate is officially appointed by the Accreditation Body to represent their state program. • A chairperson is selected by the members of the NELAP Board. • Program administrator to help with administrative functions. • Strict voting rules, especially for recognizing an AB.

6. NELAP BOARD DUTIES • The recognition of accreditation bodies, • The adoption of acceptance limits for proficiency testing, and • Implementation of the policies and procedures that govern the operation of the program.

7. NELAC 2003 1, Program Policy Scope of Accreditation Reciprocity Secondary Accreditation 2, Proficiency Testing 3, On-Site Assessment 4, Accreditation Process 6, Accrediting Authority Policies The new TNI standard Module I: General Requirements Module 2: Proficiency Testing Module 3: On-Site Assessment Guidance and SOPs REQUIREMENTS FOR ACCREDITATION BODIES

8. BASIS OF NEW STANDARD • International Standard ISO/IEC 17011:2004(E) • Conformity assessment – general requirements for accreditation bodies accrediting conformity assessment bodies • Conformity Assessment Body (CAB) = Laboratory

9. MODULE 1: GENERAL • Scope • Normative References • Terms & Definitions • Accreditation Body • Management • Human Resources • Accreditation Process • Responsibilities of the AB and CAB

10. 1-3. SCOPE, REFERENCES AND TERMS • Important terms • Conformity assessment body (CAB) = laboratory • Accreditation is attestation of laboratory competence • Accreditation Body is the body that grants the accreditation • Laboratory assessment includes competence of entire operation, including personnel, test methods and validity of results • Field of accreditation defined as matrix, technology/method and analyte combination

11. 4. ACCREDITATION BODY • Registered legal entity • Structure to give confidence in decisions • Organized and operated to ensure objectivity and impartiality • Safeguard confidentiality of information • Adequate financial resources • Clearly describe policies and procedures for granting accreditation

12. 5. MANAGEMENT • Implement quality system • Document control • Records • Corrective actions • Preventative actions • Internal audits • Management reviews • Complaints

13. 6. HUMAN RESOURCES • Sufficient number of qualified assessors • Monitoring • Records

14. 7. ACCREDITATION PROCESS • General criteria for processes available • Application process • May subcontract the assessment, but not the accreditation decision • Certificate • Denial, suspension, withdrawal • Assessment

15. 8. RESPONSIBILITIES • Laboratory • Fulfill PT and Quality System requirements • Allow AB to inspect operation • Provide AB necessary documents • Not misuse accreditation status • Pay fees • Notify AB of significant changes

16. 8. RESPONSIBILITIES • Accreditation Body • Make accreditation status publicly available • Ensure laboratory fully conforms with requirements

17. MODULE 2 - PT • Specific requirements for accreditation bodies regarding PT • Criteria is consistent with current NELAC • 2 samples per year; pass 2 out of 3 • Evaluation of sample analysis process during on-site • Review results and evaluate data • Suspend or revoke accreditation based on PT failures

18. MODULE 3 – ON-SITE ASSESSMENT • Introduction, Scope and Applicability • References • Terms and Definitions • Human Resources • Frequency • Process • Changes in Laboratory Capability

19. TYPES OF ASSESSMENTS • Initial • Reassessment • Surveillance • Follow-up • Extraordinary

20. ASSESSMENT PROCESS • Assessors may not provide consultancy and must avoid any conflict of interest • Initial assessment may be cancelled based on deficiencies identified in document review

21. GUIDANCE AND SOPs • Technical Training for Assessors • On-site Assessment Guidance • SOP for Evaluating Accreditation Bodies • Other guidance is being developed

22. EVALUATION OF ABs • Once every three years • Evaluation team • State or EPA regional personnel • QA Officer • Decision by NELAP Board

23. EVALUATION PROCESS • Completeness check of an AB’s application. • Technical review of materials. • On-site evaluation. • Observation of a laboratory assessment. • Prepare the on-site evaluation report. • Respond to the AB’s corrective action plans. • Provide recommendations to the NELAP Board.

24. COSTS AND FEES • Currently, ABs provide one of their staff to participate in the evaluation process, including cost of travel. • In the future, there will be a fee which will cover cost of evaluation, limited membership benefits. This will probably be around $6K

25. HOW TO BECOME AN AB • Become familiar with the Standard • Decide on the scope of accreditation you want • Complete the Accreditation Body Application form and the following checklists • Application Completeness • Checklist to Determine Accreditation Body Compliance • Fields of Accreditation • More details on the TNI website