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. REQUIREMENTS FOR ACCREDITATION BODIES  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

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