KAN-P-06 - KAN Policy on Proficiency Testing
KAN-P-06
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
Website : http://www.kan.or.id
Dokumen ini tidak dikendalikan jika diunduh/ Uncontrolled when downloaded
KAN-P-06
Issue Number : 6
April 2016
APPROVAL SHEET
Reviewed by
:
Director for Accreditation of Laboratory and Inspection Body
Approved by
:
Secretary General of Komite Akreditasi Nasional
Dokumen ini tidak dikendalikan jika diunduh/ Uncontrolled when downloaded
i
KAN-P-06
Issue Number : 6
April 2016
LIST OF AMANDMENT
No.
Date
Part number
revised
Brief description of changes
Part
revision
number
1.
12 June 2008 Identification
document
DPLP 11
Identification document changed to KANP-06
2
2.
28 May 2009 Part C point 1;
Part C point 2
(c)
Changing - “...section 5.6.4......” with
“...section 5.6.5......”
3
3.
07 January
2011
Whole
Changing ISO/IEC Guide 43 to ISO/IEC
17043
4
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
Clause 5
Adding proficiency testing plan
6
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ii
KAN-P-06
Issue Number : 6
April 2016
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.
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.
Dokumen ini tidak dikendalikan jika diunduh/ Uncontrolled when downloaded
1
KAN-P-06
Issue Number : 6
April 2016
B. Policies on Proficiency Testing for Accreditation Requirements
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
5.6 of 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
Others
1 / year
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2
KAN-P-06
Issue Number : 6
April 2016
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.
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 5.9 of ISO/IEC 17025 and section 5.6.5 of ISO 15189 for medical
laboratories.
Dokumen ini tidak dikendalikan jika diunduh/ Uncontrolled when downloaded
3
KAN-P-06
3.
Issue Number : 6
April 2016
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.
b)
As APLAC normally invites maximum 4 participants 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.
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4
KAN-P-06
c)
Issue Number : 6
April 2016
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.
4. MR 001 : Procedures for Establishing and Maintaining the APLAC Mutual Recognition
Arrangement Amongst Accreditation Bodies.
Dokumen ini tidak dikendalikan jika diunduh/ Uncontrolled when downloaded
5
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
: laboratorium@bsn.go.id
Website : http://www.kan.or.id
Dokumen ini tidak dikendalikan jika diunduh/ Uncontrolled when downloaded
KAN-P-06
Issue Number : 6
April 2016
APPROVAL SHEET
Reviewed by
:
Director for Accreditation of Laboratory and Inspection Body
Approved by
:
Secretary General of Komite Akreditasi Nasional
Dokumen ini tidak dikendalikan jika diunduh/ Uncontrolled when downloaded
i
KAN-P-06
Issue Number : 6
April 2016
LIST OF AMANDMENT
No.
Date
Part number
revised
Brief description of changes
Part
revision
number
1.
12 June 2008 Identification
document
DPLP 11
Identification document changed to KANP-06
2
2.
28 May 2009 Part C point 1;
Part C point 2
(c)
Changing - “...section 5.6.4......” with
“...section 5.6.5......”
3
3.
07 January
2011
Whole
Changing ISO/IEC Guide 43 to ISO/IEC
17043
4
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
Clause 5
Adding proficiency testing plan
6
Dokumen ini tidak dikendalikan jika diunduh/ Uncontrolled when downloaded
ii
KAN-P-06
Issue Number : 6
April 2016
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.
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.
Dokumen ini tidak dikendalikan jika diunduh/ Uncontrolled when downloaded
1
KAN-P-06
Issue Number : 6
April 2016
B. Policies on Proficiency Testing for Accreditation Requirements
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
5.6 of 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
Others
1 / year
Dokumen ini tidak dikendalikan jika diunduh/ Uncontrolled when downloaded
2
KAN-P-06
Issue Number : 6
April 2016
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.
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 5.9 of ISO/IEC 17025 and section 5.6.5 of ISO 15189 for medical
laboratories.
Dokumen ini tidak dikendalikan jika diunduh/ Uncontrolled when downloaded
3
KAN-P-06
3.
Issue Number : 6
April 2016
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.
b)
As APLAC normally invites maximum 4 participants 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.
Dokumen ini tidak dikendalikan jika diunduh/ Uncontrolled when downloaded
4
KAN-P-06
c)
Issue Number : 6
April 2016
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.
4. MR 001 : Procedures for Establishing and Maintaining the APLAC Mutual Recognition
Arrangement Amongst Accreditation Bodies.
Dokumen ini tidak dikendalikan jika diunduh/ Uncontrolled when downloaded
5