Transcript The New TNI Laboratory Accreditation Standards Requirements for an Accreditation Body

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:






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.
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





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.
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



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