The New TNI Laboratory Accreditation StandardsRequirements 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 BodyApplication Being ProcessedWorking on Program/ApplicationRequire ProgramRecognize ProgramIncorporated Program Components

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.

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.

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 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

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

MODULE 1: GENERAL

1. Scope2. Normative References3. Terms & Definitions4. Accreditation Body5. Management6. Human Resources7. Accreditation Process8. Responsibilities of the AB and CAB

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

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

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

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

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 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. Introduction, Scope and Applicability2. References3. Terms and Definitions4. Human Resources5. Frequency6. Process7. 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

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 $6K

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