The New TNI Laboratory Accreditation Standards

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The New TNI Laboratory Accreditation Standards

• Requirements for an Accreditation Body

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FUNDAMENTAL CONCEPTS

• TNI develops consensus standards that are
  voluntarily adopted by states agencies designated
  as accreditation bodies (ABs).
• TNIs 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.

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

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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.

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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.

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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

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BASIS OF NEW STANDARD

• International Standard ISO/IEC 170112004(E)
• Conformity assessment general requirements for
  accreditation bodies accrediting conformity
  assessment bodies
• Conformity Assessment Body (CAB) Laboratory

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MODULE 1 GENERAL

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

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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

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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

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5. MANAGEMENT

• Implement quality system
• Document control
• Records
• Corrective actions
• Preventative actions
• Internal audits
• Management reviews
• Complaints

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6. HUMAN RESOURCES

• Sufficient number of qualified assessors
• Monitoring
• Records

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7. ACCREDITATION PROCESS

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

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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

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8. RESPONSIBILITIES

• Accreditation Body
• Make accreditation status publicly available
• Ensure laboratory fully conforms with requirements

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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

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MODULE 3 ON-SITE ASSESSMENT

• Introduction, Scope and Applicability
• References
• Terms and Definitions
• Human Resources
• Frequency
• Process
• Changes in Laboratory Capability

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TYPES OF ASSESSMENTS

• Initial
• Reassessment
• Surveillance
• Follow-up
• Extraordinary

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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

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GUIDANCE AND SOPs

• Technical Training for Assessors
• On-site Assessment Guidance
• SOP for Evaluating Accreditation Bodies
• Other guidance is being developed

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EVALUATION OF ABs

• Once every three years
• Evaluation team
• State or EPA regional personnel
• QA Officer
• Decision by NELAP Board

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EVALUATION PROCESS

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

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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

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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

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