KAN-P-06

KAN POLICY ON
PROFICIENCY TESTING

Issue Number : 4
January 2011

Komite Akreditasi Nasional

National Accreditation Body of Indonesia
Gedung Manggala Wanabakti, Blok IV, Lt. 4
Jl. Jend. Gatot Subroto, Senayan, Jakarta 10270 – Indonesia
Tel. : 62 21 5747043, 5747044
Fax. : 62 21 57902948, 5747045
Email : laboratorium@bsn.or.id
Website : http://www.bsn.or.id

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 KAN-P-06 Issue Number : 4 07 Januari 2011

LIST OF AMANDMENT

Part
Part number
No. Date Brief description of changes revision
revised
number

1. 12/06/08 Identification Identification document changed to KAN- 2

document P-06
DPLP 11

2. 28/05/09 Part C point 1; Changing - “...section 5.6.4......” with 3

Part C point 2 “...section 5.6.5......”
(c)

3. 07/01/2011 Whole Changing ISO/IEC Guide 43 to ISO/IEC 4

17043

ii
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 KAN-P-06 Issue Number : 4 07 Januari 2011

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 APLAC MR 001 Document. These cover the program,
proficiency testing expert group, provider laboratory, participation, performance,
confidentiality and funding. The general information on laboratory accreditation
should be considered in conjunction with these policies.

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.

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.

B. Policies on Proficiency Testing Program

1. KAN Proficiency Testing Program

KAN conducts annual proficiency testing program for both testing and calibration
laboratories. Due to the big variety on scope of testing and calibration, the selection of
program is carried out based on the following criteria:

- be the accreditation scope possessed by relatively big number of laboratories;

and/or
- be the accreditation scope that significantly contribute directly or indirectly to the
main Indonesian export commodities (products); and /or
- be supposed to be carrying out of obligatory national standard (SNI)

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 KAN-P-06 Issue Number : 4 07 Januari 2011

In addition, KAN also actively participate in other proficiency testing activities

coordinated by regional (ASEAN and Asia Pacific), or international bodies.

For external quality assessment/proficiency testing of medical laboratory, KAN

recognizes external quality assessment from provider that has been listed in APLAC
PT directory. In addition KAN also recognizes external quality assessment from
provider that has been registered by KAN.

2. Proficiency Testing Expert Group

In executing proficiency testing program, KAN forms Proficiency Testing Expert

Group (PTEG). The main task of the PTEG is to plan, including preparation of
proficiency testing protocol, to carry out and to evaluate the results. Criteria of being
member of PTEG are as follows:

- be competent in the relevant field of testing, medical and/or calibration laboratories;

- have appropriate knowledge on proficiency testing, particularly in relation to the
understanding of ISO/IEC 17043 and ISO 13528;
- for being the leader of PTEG must have experience in conducting proficiency
testing program.

3. Sample/Artifact Provider

KAN appoints sample/artifact provider to prepare the test sample and/or artifact for
the need of proficiency testing. Criteria of sample/artifact provider for being appointed
is as the following :

- be KAN-accredited laboratory for testing, medical laboratory and National

Measurement Institute for calibration laboratory;
- having sufficient competency in the preparation of test sample and/or artifact.

4. Participant

Participants of KAN Proficiency Testing Program are mainly KAN-accredited testing,

medical and calibration laboratories. Other laboratories may also participate in KAN
Proficiency Testing Program regardless their status as far as they follow KAN rule
and procedure on Proficiency Testing.

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 KAN-P-06 Issue Number : 4 07 Januari 2011

5. Confidentiality

As for KAN’s assessment activities, all information supplied by a laboratory as part of

proficiency testing is treated as confidential. This information will, however, be
made available to the assessor(s) of laboratory, the PTEG and KAN technical
committee on laboratory accreditation. All of these people are fully aware of
confidentiality of the results.

6. Funding

The current policy is to levy each participant in a program with a fee that contributes
to the cost for conducting that program. The varies from program to program and
participants are notified accordingly prior to commencement the program.

C. Policies on Proficiency Testing for Accreditation Requirements

1. Laboratory Applying KAN Accreditation

Testing, medical or calibration laboratories 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, KAN-accredited laboratories are
required to demonstrate proficiency with internal performance-based data in
compliance with section 5.9 of ISO/IEC 17025 and section 5.6.5 of ISO 15189 for
medical laboratories.

2. KAN-Accredited Laboratories

KAN-accredited laboratories shall participate in proficiency testing program at least

once a year. For their main scope of accreditation, KAN-accredited laboratories shall
participate in proficiency testing program at least once during its accreditation period.
a. KAN-accredited laboratories shall participate in KAN Proficiency Testing
Program whenever such program is appropriate with their scope of accreditation.
b. If KAN does not conduct proficiency testing program for certain areas, KAN-
accredited laboratories are encouraged to conduct their own proficiency testing
program or to participate in proficiency testing program which are organized based
on ISO/IEC 17043 principles and submit the results of their participation to KAN as
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 KAN-P-06 Issue Number : 4 07 Januari 2011

soon as possible.
c. Should there is no such proficiency testing program being available, KAN-
accredited laboratories are required to demonstrate proficiency with internal
performance-based data in compliance with section 5.9 of ISO/IEC 17025 and
section 5.6.5 of ISO 15189 for medical laboratories.

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

Accredited Laboratory

a) KAN-accredited laboratories shall carry out investigation for every unsatisfactory

proficiency testing results. The result of investigation and evidence of
corrective action shall be submitted to KAN not later than 30 days after
laboratory received proficiency testing result.
b) If KAN-accredited laboratories do not submit investigation result and corrective
action within the defined time, the related scope of accreditation will be
temporarily suspended.
c) Corrective action from KAN-accredited laboratory (point a and point b), will be
verified by KAN experts as soon as the corrective action are available.
d) If the result of verification reveal that the corrective action taken have not been
effective, KAN conduct surveillance visit earlier than surveillance schedule or
conduct un-scheduled surveillance visit and or carry out measurement audit for
the outlier results.
e) If the result of surveillance and or measurement audit as stated in point d have
not been effective, the related scope of accreditation will be
suspended/withdrawn.

4. Selection Criteria of Laboratories to Participate in APLAC Proficiency

Testing Program

a) Whenever possible, the laboratory should be KAN-accredited laboratory with

scope of accreditation appropriate to the APLAC Proficiency Testing Program
being conducted.
b) As APLAC normally invites maximum 4 laboratories from each APLAC member,
if there are more than 4 laboratories eligible to the APLAC 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 APLAC Proficiency Testing
Program, KAN will invite non accredited laboratories as considered to be the
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 KAN-P-06 Issue Number : 4 07 Januari 2011

prospective laboratories.

D. References

1. ISO/IEC 17043: Conformity assessment -- General requirements for proficiency testing.

2. ISO 13528: Statistical methods for use in proficiency testing by interlaboratory comparisons.
3. ILAC-G22: Use of proficiency testing as a tool for accreditation in testing
4. ILAC-P9: ILAC Policy for participation in national and international proficiency testing
activities.

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