KAN-P-06 - KAN Policy on Proficiency Testing

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KAN POLICY ON

PROFICIENCY TESTING

Issue Number : 6 April 2016

Komite Akreditasi Nasional

National Accreditation Body of Indonesia Gedung BPPT 1, Lt. 14

Jl. M.H. Thamrin No. 8, Jakarta Pusat 10340 – Indonesia Tel. : 62 21 3927422 ext. 173, 194, 195, 197, 210, 211 Fax. : 62 21 3927528

Email : laboratorium@bsn.go.id

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KAN-P-06 Issue Number : 6 April 2016

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APPROVAL SHEET

Reviewed by :

Director for Accreditation of Laboratory and Inspection Body

Approved by :

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LIST OF AMANDMENT

No. Date Part number

revised Brief description of changes

Part revision number

1. 12 June 2008 Identification document

Whole Changing ISO/IEC Guide 43 to ISO/IEC 17043

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4. 01 August 2012

Whole Adding Inspection Body, if relevan 5

Clause C.1 Adding PT plans prepared by the

laboratory or inspection body (if relevant) with regard to their suitability in relation to the scope of accreditation.

5. 07 April 2016 Clause B.2 Adding minimum frequency of PT 6

Clause 3 Adding clause 3.1 and 3.2 6

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KAN POLICY ON PROFICIENCY TESTING

A. General

National Accreditation Body of Indonesia (KAN) establish policies relating to proficiency testing program to support the operation of KAN’s ISO/IEC 17011 - based laboratory accreditation system. The policies are also to fulfill the requirements of proficiency testing stated in ILAC P 09 ILAC Policy for Participation in Proficiency Testing Activities and APLAC MR 001 Procedures for Establishing and Maintaining the APLAC Mutual Recognition Arrangement Amongst Accreditation Bodies.

The primary function of proficiency testing programs is to assess laboratories’ ability to competently perform tests and/or measurements for which KAN accreditation is being held or sought. They supplement laboratories’ own internal quality control procedures by providing an additional external audit of their testing capability and complement KAN’s other ordinary assessment activities.

This policy also considers and makes use of PT requirements set by regulators, industry or professional sectors, regional cooperation bodies, or other interested parties.

Proficiency testing activities are also applicable to certain types of inspection. KAN encourage its accredited inspection bodies to participate where relevant proficiency testing activities are available.

For calibration laboratory, the function of proficiency testing programs is also to evaluate CMC.

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1. Laboratory and Inspection Body Applying KAN Accreditation

Testing, medical, calibration laboratories or inspection body, if relevant, that are applying for KAN accreditation shall have participated on, as a minimum, one KAN Proficiency Testing or other proficiency testing program organized by reputable organization based on ISO/IEC 17043 principles for their main scope of accreditation being sought. Should there is no such proficiency testing program being available and appropriate, the laboratories are required to participate in interlaboratory comparison preferably with at least 3 laboratories (where applicable and available). Should interlaboratory comparison is not applicable, the laboratory shall demonstrate internal performance-based data in compliance with section 5.9 of ISO/IEC 17025 and section 5.6of ISO 15189 for medical laboratories.

2. Accredited Laboratories or Inspection Body

Accredited laboratories or inspection bodies, if relevant, shall participate in proficiency testing program with minimum participation of frequency according to Table 1 and Table 2 below, over the validity of accreditation certificate.

The minimum frequency of PT is described as follow:

Table 1. The minimum frequency of PT for Testing Laboratory

Scope Minimum Frequency

Physical 1 / year

Mechanical 1 / year

Chemical 1 / year

Biological 1 / year

Electrical 1 / year

Medical (each area) 1 / year

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Table 2. The minimum frequency of PT for Calibration Laboratory

Scope Minimum Frequency

Temperature and Humidity 1 / two years Mass and Related Quantities 1 / two years Length and Related Quantities 1 / two years

Electrical 1 / two years

Time and Frequency 1 / two years

Accoustics and Vibration 1 / two years Photometry and Radiometery 1 / two years

Testing and Analytical Instruments 1 / two years

Ionizing Radiation 1 / two years

In order to fulfil the minimum frequency of PT, the accredited laboratory shall participate in proficiency testing program organized by accredited proficiency testing provider under ISO/IEC 17043 or reputable organization based on ISO/IEC 17043 principles. The accredited PTP includes the accredited PTP of other accreditation body that has been signed APLAC/ILAC MRA for PTP.

Accredited laboratories or inspection bodies, if relevant, shall participate in KAN Proficiency Testing Program whenever such program is appropriate with their scope of accreditation. Failure to participate in KAN Proficiency Testing Program may jeaopardise the accreditation status, such as suspension of the laboratory accreditation.

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3. Requirements on Follow Up Action for Proficiency Testing Results for

Accredited Laboratory or Inspection Body

3.1 Follow Up Action for Non KAN and Non APLAC Proficiency Testing Results

for Accredited Laboratory or Inspection Body

a. When result of program revealed outlier, the laboratory shall record corrective action in response to the performance in the PT.

b. The laboratory shall maintain corrective action and record it at PT plan.

c. The effectiveness of such corrective actions will be verified by assesor in the next assesment visit.

d. If necessary, KAN may conduct unscheduled visit to verify the follow-up results of the proficiency testing.

3.2 Follow Up Action for KAN and APLAC Proficiency Testing Results for

Accredited Laboratory or Inspection Body

a. When result of program revealed outlier, the laboratory shall record corrective action in response to the performance in the PT.

b. The laboratory shall inform KAN within one month of receiving the result c. The investigation and corrective action will be verified by Secretariat KAN.

d. The effectiveness of such corrective actions will be verified by Assessor in the next assesment visit.

e. If necessary, KAN may conduct unscheduled visit to verify the follow-up results of the proficiency testing.

4. Selection Criteria of Laboratories to Participate in APLAC Proficiency

Testing Program

a) Whenever possible, the laboratory should be accredited with scope of accreditation appropriate to the APLAC Proficiency Testing Program being conducted.

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c) If there are less than 4 laboratories eligible to the APLAC Proficiency Testing Program, KAN will invite non accredited laboratories as considered to be the prospective laboratories.

5. Proficiency Testing Plan

All applying laboratories or inspection body, if relevant, are required to submit a proficiency testing participation plan. All accredited laboratories or inspection body, if relevant, shall have PT participation plan for one accreditation cycle. KAN shall review the PT plans submitted by the laboratory or inspection body (if relevant) with regard to their suitability in relation to the scope of accreditation. During each assesment visit, laboratory shall provide evidence to the assesment team that it has participated in proficiency testing programmes in accordance to at least the minimum frequency stated in Table 1 and Table 2. The lead assesor shall review the proficiency testing implementation plans for the preceding 4 (four) years with evidence of participation and review the perfomance.

In order to give information related to listings or direction to possible sources of PT as well as considerations for selecting suitable programs, KAN upload list of PT Program from accredited PTP in Indonesia and list of PT Program from accredited PTP outside Indonesia in www.bsn.go.id.

D. References

1. ISO/IEC 17043 : Conformity Assessment–General Requirements for Proficiency Testing Provider.

2. ILAC-G22 : Use of Proficiency Testing as Tool for Accreditation in Testing. 3. ILAC-P9 : ILAC Policy for Participation in Proficiency Testing Activities.