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KAN U-08 Policy On Proficiency Testing
KAN U-08 Policy On Proficiency Testing
DAFTAR ISI
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
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 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.
Since the main objective is to contribute to the assessment of the competence of
laboratories, an appropriate evaluation of performance is the most important mean.
For this reason, the following policies have been formulated.
2. Accredited Laboratories
Accredited laboratories, 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
Physical 1 / year
Mechanical 1 / year
Chemical 1 / year
Biological 1 / year
Electrical 1 / year
Others 1 / year
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 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 7.7 of ISO/IEC 17025
and section 5.6 of ISO 15189 for medical laboratories.
6. Statistical Design
Statistical design and participant performance evaluation commonly based on ISO
13528.
7. References
a. ISO/IEC 17043, Conformity Assessment–General Requirements for Proficiency
Testing Provider.
b. ILAC-P9, ILAC Policy for Participation in Proficiency Testing Activities.