KAN U-08

Table of Content

A. General ........................................................................................................................... 1
B. Policies on Proficiency Testing for Accreditation Requirements ..................................... 1
1. Laboratory Applying KAN Accreditation ......................................................................... 1
2. Accredited Laboratories ................................................................................................. 2
3. Requirements on Follow Up Action ................................................................................ 3
4. Selection Criteria of Laboratories to Participate .................................................... 4
5. Proficiency Testing Plan ................................................................................................. 4
6. Statistical Design ............................................................................................................ 4
7. References ..................................................................................................................... 4

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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 APAC MRA 001 Procedures for Establishing Maintaining Mutual
Recognition Amongst APAC Accreditation Bodies.
The primary function of proficiency testing programs is to assess laboratory’s ability
to competently perform test and/or measurement for which KAN accreditation is
being held or sought. They supplement laboratory 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.
Since the main objective is to contribute to the assessment of the competence of
laboratory, an appropriate evaluation of performance is the most important mean.
For this reason, the following policies have been formulated.

B. Policies on Proficiency Testing for Accreditation Requirements

1. Laboratory Applying KAN Accreditation
Testing, medical, calibration laboratory and 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 laboratory is required to participate
in interlaboratory comparison preferably with at least 3 laboratories (where
relevant, applicable and available). Should interlaboratory comparison is not

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applicable, the laboratory shall demonstrate internal performance-based data in

compliance with section 7.7 of ISO/IEC 17025 and section 5.6 of ISO 15189
for medical laboratory.

2. Accredited Laboratory
Accredited laboratory, 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

Others 1 / year

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

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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 APAC MRA for PTP.
Should there is no Proficiency Testing Program being available and appropriate,
the laboratory is 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 7.7 of ISO/IEC 17025
and section 5.6 of ISO 15189 for medical laboratory.

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

Accredited Laboratory or Inspection Body
3.1 Follow Up Action for Non APMP/APAC 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.
c. The effectiveness of such corrective actions will be verified by assesor
in the next on-site assesment.
d. If necessary, KAN may conduct unscheduled visit to verify the follow-
up results of the proficiency testing.
3.2 Follow Up Action for APMP/APAC 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 KAN
permanent personnel
d. The effectiveness of such corrective actions will be verified by
Assessor in the next on-site assesment.
e. If necessary, KAN may conduct unscheduled visit to verify the follow-
up results of the proficiency testing.

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4. Selection Criteria of Laboratory to Participate in APMP/APAC Proficiency

Testing Program
a. Whenever possible, the laboratory should be accredited with scope of
accreditation appropriate to the APMP/APAC Proficiency Testing Program
being conducted.
b. As APAC normally invites maximum 4 participants from each APAC member,
if there are more than 4 laboratories eligible to the APMP/APAC
Proficiency Testing Program, priority will be given to laboratory who has
never participated in any proficiency testing program for their scope of
accreditation during their period of accreditation.
c. If there are less than 4 laboratories eligible to the APMP/APAC 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 bodies, if relevant, are required to submit
a proficiency testing participation plan. All accredited laboratories or inspection
bodies, if relevant, shall have PT participation plan for one accreditation cycle.
PT plans submitted by the laboratories or inspection bodies (if relevant) shall be
reviewed with regard to their suitability in relation to the scope of accreditation.
During each on-site assesment, 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.

6. Statistical Design
Statistical design and participant performance evaluation commonly based on ISO
13528.

7. References
a. ILAC-P9, ILAC Policy for participation in proficiency testing activities.
b. APAC MRA 001, Procedures for establishing maintaining mutual recognition
amongst APAC accreditation bodies
c. ISO/IEC 17020, Conformity Assessment – Requirements for the operation of
various types of bodies performing inspection
d. ISO/IEC 17025, General requirements for the competence of testing and

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calibration laboratories
e. ISO 15189, General requirements for the competence of medical laboratories
f. ISO/IEC 17043, Conformity Assessment – General Requirements for
proficiency Testing Provider
g. ISO 13528, Statistical methods for use in proficiency testing by interlaboratory
comparison

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