The New TNI Laboratory Accreditation Standards Requirements for

The New TNI Laboratory Accreditation Standards Requirements for an Accreditation Body

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.

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

IMPLEMENTATION ¨ States adopt standards voluntarily: Ø Ø Ø ¨ 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 Ø Ø Accept reciprocity; and Refrain from adding supplemental requirements.

NELAP BOARD ¨ One representative and one alternate from each NELAP-recognized Accreditation Body. Ø ¨ ¨ ¨ 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.

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.

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

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

MODULE 1: GENERAL 1. 2. 3. 4. 5. 6. 7. 8. Scope Normative References Terms & Definitions Accreditation Body Management Human Resources Accreditation Process Responsibilities of the AB and CAB

1 -3. SCOPE, REFERENCES AND TERMS ¨ Important terms Ø Ø Ø 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 analyte combination

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

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

6. HUMAN RESOURCES ¨ ¨ ¨ Sufficient number of qualified assessors Monitoring Records

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

8. RESPONSIBILITIES ¨ Laboratory Ø Ø Ø 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

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

MODULE 2 - PT ¨ ¨ Specific requirements for accreditation bodies regarding PT Criteria is consistent with current NELAC Ø Ø 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

MODULE 3 – ON-SITE ASSESSMENT 1. 2. 3. 4. 5. 6. 7. Introduction, Scope and Applicability References Terms and Definitions Human Resources Frequency Process Changes in Laboratory Capability

TYPES OF ASSESSMENTS ¨ ¨ ¨ Initial Reassessment Surveillance Follow-up Extraordinary

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

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

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

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.

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 $6 K

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 Ø Ø Ø ¨ Application Completeness Checklist to Determine Accreditation Body Compliance Fields of Accreditation More details on the TNI website