NABL 163 -Policy for Participation in Proficiency Testing Activities.pdf

NABL 163

NABL NATIONAL ACCREDITATION BOARD FOR TESTING AND CALIBRATION LABORATORIES

POLICY

for PARTICIPATION IN PROFICIENCY TESTING ACTIVITIES

ISSUE NO : 06 AMENDMENT NO : 00 ISSUE DATE: 27.06.2012 AMENDMENT DATE: --

National Accreditation Board for Testing and Calibration Laboratories Doc. No: NABL 163 Policy for Participation in Proficiency Testing Activities Issue No: 06 Issue Date: 27.06.2012 Amend No: 00 Amend Date:-- Page No: 1 / 6

AMENDMENT SHEET

Sl Page

No. Clause

No. Date of

Amendment Amendment made Reasons Signature

QO Signature Director

1.

2.

3.

4.

5.

6.

7.

8.

9.

10.


CONTENTS

Sl. No. Title Page Amendment sheet 1

Contents 2

1. Introduction 3

2. Scope 3

3. NABL policy 3

4. Requirements 4


1. INTRODUCTION

Proficiency Testing is one of the important tools to determine the technical competence of the testing/calibration laboratories.

According to ISO/IEC 17025:2005, participation in Proficiency Testing programs /Inter laboratory comparison is significant means for assuring the quality of test/calibration results.

According to ISO 15189:2007, medical laboratories shall participate in interlaboratory comparisons such as those organized by external quality assessment schemes.

This document derives NABL policy on participation in Proficiency testing activities to conform to the requirements of ILAC-P9:11/2010., ILAC Policy for Participation in Proficiency Testing activities.

2. SCOPE

This document stipulates the minimum requirements of PT participation during accreditation process of testing, calibration and/ or medical laboratories.

This also gives information about the measures against poor performance of laboratories in defined in Proficiency Testing program.

3. NABL POLICY

3.1. Applicant laboratory shall successfully participate in one PT program prior to gaining accreditation in each discipline applied.

3.2. Accredited laboratory shall have 4-year plan for Proficiency Testing participation which shall cover all the accredited groups as practicable (e.g. Food & agriculture, pressure & vacuum, high voltage, building material, etc.) under each discipline of accreditation (e.g. Chemical, Mechanical, Electrical etc.). In Medical testing, accredited laboratories shall participate at least one Proficiency Testing / External Quality Assurance Scheme in a year per discipline, as appropriate.


3.3. Successful participation in national / international PT programs enhance the confidence in the competence of laboratories.

3.4. Successful participation in PT is necessary for significant enhancement of scope such as addition of discipline and/ or group.

3.5. Laboratory shall take appropriate corrective actions in case of poor performance in PT programs within two months period. In two consecutive events of poor performance in PT participation/ unsatisfactory corrective actions leads to the scope reduction.

3.6. Apart from the above defined minimum requirements, Laboratory shall abide by the PT participation required by the respective Regulators, NABL & regional bodies like APLAC.

4. REQUIREMENTS

4.1 Accredited laboratory shall submit 4 year PT plan as per the Form 18 (Annexure A) which will be reviewed by NABL for its suitability in relation to the scope of accreditation. In case of non-suitability of the PT plan submitted by the laboratory, NABL may guide in identifying the required PT coverage.

4.2 NABL provides guidance to the laboratories regarding the proficiency testing programs through its website, by giving reference to international programs enlisted by on EPTIS, FAPAS etc. This helps the laboratories in participating in other programs, in case there are not national programs available.

4.3 The PT program should be conducted in accordance with ISO/ IEC 17043:2010. All techniques covered in ISO/IEC 17043:2010 shall be acceptable for the purpose of Proficiency Testing.

4.4 At the time of on-site assessment, assessment team shall verify whether the laboratories have participated in recognized Proficiency Testing Program as per the PT plans (approved plans as per Form 18 ) and whether the necessary corrective action were taken, if in terms of z-Score, En values etc. the laboratory performance has not been satisfactory.

Note: For calibration laboratories, measurement audits will be considered to be a complimentary effort to

Inter-Laboratory Proficiency Testing. The calibration laboratories will be provided with artifacts with their


characterization by National Physical Laboratory, New Delhi or nodal laboratories appointed by NABL for

the same objective or any other NMI’s who are signatory to BIPM.

4.5 NABL shall nominate its accredited/applicant laboratories for participation in APLAC and other international Proficiency Testing program, as and when they are available. Following sequential preference shall be given to the laboratories.

• Accredited laboratories not having participated in any other APLAC PT program.

• Accredited laboratories not having participated in NABL PT program or any other program recognized by NABL.

• Laboratories having unsatisfactory performance in a past PT program.

• Laboratory with long period of accreditation

• Applicant laboratory

NABL shall co-ordinate all activities related to PT program with APLAC and the participating laboratories.

4.6 In the field of calibration where formal PT Programs are not available, alternatively the applicant / accredited laboratories may participate in suitable inter-laboratory comparisons, as per NABL 164 ‘Guidelines for Inter-laboratory Comparison for Calibration Laboratories where formal PT

Programs are not available’.

4.7 In the field of Testing where formal PT Programs are not available or appropriate, alternatively the applicant / accredited laboratories may participate in suitable inter-laboratory comparisons with adequate number of accredited laboratories, as per NABL 162 ‘Guidelines for Proficiency Testing

Programs for Testing Laboratories’ where formal PT Programs are not available’. In case, the accredited laboratories are not available for a particular test then non-accredited laboratories with sufficient infrastructure and resources may be considered by NABL to act as nodal laboratories


Annexure A

Form 18

4- Year Proficiency Testing Participation Plan

Laboratory ID

Laboratory Name

Field of Accreditation Testing / Calibration / Medical

4 - Year Period of Participation

Accredited Discipline(s)

Group(s) under Discipline

Proficiency Testing Participation Plans (Year wise)

Remarks (for NABL use

only)

Note: laboratory should ensure that PT plan covers the major parameters in each group under the relevant discipline

For NABL use only

Reviewed by:

Approved by:

National Accreditation Board for Testing and Calibration Laboratories 3rd Floor, NISCAIR

14, Satsang Vihar Marg New Mehrauli Road New Delhi – 110 067

Tel.: +91-11 46499999 Fax: +91-11 26529716

Website: www.nabl-india.org

http://www.nabl-india.org/�

Documents

NABL 163 -Policy for Participation in Proficiency Testing Activities.pdf