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URP24-04

IAJapan Policy on Proficiency Testing

(4th edition)

July 8, 2014

International Accreditation Japan (IAJapan)

National Institute of Technology and

Evaluation (NITE)



Contents

1. Purpose ............................................................................................................... 4

2. Scope................................................................................................................... 4

3. Normative reference ........................................................................................... 4

4. Terminology ........................................................................................................ 6

5. Types of proficiency testing schemes and interlaboratory comparisons which are

available for IAJapan ............................................................................................. 6

5.1 Proficiency testing schemes which are available in the assessment and

accreditation process ...................................................................................... 6

5.2 Interlaboratory comparisons which are available in the assessment and

accreditation process ...................................................................................... 7

6. Basic policy on proficiency testing ...................................................................... 8

6.1 Basic policy on proficiency testing participation plan ................................... 8

6.2 Basic policy on participation for proficiency testing ...................................... 8

6.3 Basic policy on notification of poor performance in proficiency testing to

IAJapan, excluding the proficiency testing which is provided by IAJapan .... 9

7. Application policy on proficiency testing requirements for individual

accreditation program .......................................................................................... 10

7.1 Application policy on proficiency testing requirements for MLAP (out of scope of

international MRA) ...................................................................................... 10

7.2 Application policy on proficiency testing requirements for JCSS ................ 10

7.3 Application policy on proficiency testing requirements for JNLA ............... 11

7.4 Application policy on proficiency testing requirements for ASNITE ........... 13

8. IAJapan alternative means policy on the areas for which suitable proficiency

testing does not exist or is not practical ............................................................... 14

9. IAJapan information providing policy regarding proficiency testing

participation plan ................................................................................................. 15

9.1 Listings and direction of proficiency testing providers................................ 15

9.2 Consideration for selecting suitable proficiency testing schemes and suitable

participation frequency ................................................................................ 15

9.3 Guidance on how to analyse and formulate the proficiency testing needs (ILAC

P9:11/2010 clause 4.5) .................................................................................. 16

10. IAJapan information providing policy for proficiency testing providers ......... 16

10.1 Information providing from IAJapan ........................................................ 16

10.2 Attendance in the committee of proficiency testing providers by IAJapan 16

10.3 Lending of proficiency testing items to proficiency testing providers, the items

which are furnished by IAJapan .................................................................. 17

Supplementary provisions (effective date) ........................................................... 18



Appendix A (Informative) Summary of international and regional requirements

on proficiency testing ........................................................................................... 19

Appendix B (Informative) Example of proficiency testing participation plan ..... 20

Appendix C (Informative) Example of alternative means which is discussed and

agreed between IAJapan and laboratory’s representative ................................... 22

Appendix D (Informative) List of proficiency testing providers which were utilized

by IAJapan ........................................................................................................... 28

Appendix E (Informative) Determination of the performance of proficiency testing

result (omitted) ..................................................................................................... 30



IAJapan Policy on Proficiency Testing

1. Purpose

The International Accreditation Japan (hereinafter referred to as "IAJapan") of

the National Institute of Technology and Evaluation operates programs to

accredit/register testing laboratories, calibration laboratories and reference

material producers. The purpose of this policy document is to ensure that these

laboratories/producers comply with requirements relating to proficiency testing as

defined in the relevant laws, standards and regulations, by setting the following

test types and policies:

(1) Types of proficiency testing schemes and interlaboratory comparisons those are

accecible/acceptable by/for IAJapan

(2) Basic policy on proficiency testing

(3) Application policy on proficiency testing requirements for individual

accreditation program

(4) Alternative means policy on the areas for which suitable PT does not exist or is

not practical

(5) Information providing policy of IAJapan regarding proficiency testing

participation plan

(6) Information providing policy of IAJapan for proficiency testing providers

2. Scope

This policy applies to the following accreditation/registration programs operated

by IAJapan:

(1) MLAP (Specified Measurement Laboratory Accreditation Program)

(2) JCSS (Japan Calibration Service System)

(3) JNLA (Japan National Laboratory Accreditation System)

(4) ASNITE (Accreditation System of National Institute of Technology and

Evaluation) for testing laboratories, calibration laboratories, and reference

material producers

3. Normative reference

In this policy document, the provisions stipulated in the laws, standards and

regulations listed below are referenced as necessary. Unless a specific year or

version is designated, reference to any of these standards is a reference to its

latest version. Reference to a specific version of an International Standard may

be read as if it is a reference to a relevant Japanese Industrial Standard (JIS) or

Technical Standard (TS) created by translating such version into Japanese

without altering its technical contents and the standard sheet format.



Measurement Act (Law, No.51, May 20, 1992)

Measurement Act Enforcement Regulation (Ministerial Ordinance of

International Trade and Industry, No.69, October 25, 1993)

Japanese Industrial Standard Act (Law, No.185, June 1, 1949)

Ministerial Ordinance for the Registered Testing Laboratories based on the

Japanese Industrial Standard Act (Ministerial Ordinance of

Health and Welfare, International Trade and Industry, and

Transportation, No.4, September 19, 1997)

Specified Measurement Laboratory Accreditation Criteria - Dioxin Category

(Ministerial announcement of Economy, Trade and Industry,

No.77, February 18, 2002, and Ministerial announcement of

Economy, Trade and Industry, No.222, August 29, 2005)

ISO 13528 Statistical methods for use in proficiency testing by interlaboratory

comparisons

ISO/IEC 17000 Conformity assessment - Vocabulary and general principles

ISO/IEC 17025 General requirements for the competence of testing and

calibration laboratories

ISO/IEC 17043 Conformity assessment - General requirements for proficiency

testing

ISO/IEC Guide 99:2007 (Corrected version 2010) International vocabulary of

metrology - Basic and general concepts and associated terms

ILAC P9:11/2010 ILAC Policy for Participation in Proficiency Testing Activities

ILAC P13:10/2010 Application of ISO/IEC 17011 for the Accreditation of

Proficiency Testing Providers

APLAC TC 008 Issue No. 4, 08/13 APLAC Requirements for and Guidance on the

Accreditation of a Reference Material Producer

APLAC PT 006 Issue No. 2, 09/10 Proficiency Testing Frequency Benchmarks

Regulation for the Registration of the Calibration Laboratories based on the

Measurement Act (Accreditation - Legislation B - Measurement

Law Registration)

General Requirements for Accreditation of JCSS Calibration Laboratories

(JCRP21)

General Requirements for Accreditation of JNLA Testing Laboratories (JNRP21)

General Requirements for Accreditation of ASNITE Testing Laboratories

(TERP21)

General Requirements for Accreditation of ASNITE Testing Laboratories of

Information Technology (TIRP21)

General Requirements for Accreditation of ASNITE Calibration Laboratories

(CARP21)



General Requirements for Accreditation of ASNITE Reference Material

Producers (RMRP21)

* The summary of international and regional requirements on proficiency testing

which provided on ILAC P9:11/2010 and APLAC TC 008 Issue No. 4, 08/13, are

shown in Appendix A.

4. Terminology

In this policy document, terms defined in ISO/IEC 17000, ISO/IEC Guide

99:2007 (hereinafter “VIM3”) and ISO/IEC 17043, the Measurement Acts and

related laws, the Industrial Standardization Act and related laws, and general

requirements of relevant accreditation/registration programs are used, and the

terms defined below are also used:

(1) PT (proficiency testing): evaluation of the testing or calibration performance of

laboratories or the measurement performance of reference material producers

against pre-established criteria by means of interlaboratory comparisons

(2) ILC (interlaboratory comparison): organization, performance and evaluation of

tests, calibrations or measurements on the same or similar items by two or more

laboratories or reference material producers in accordance with predetermined

conditions

(3) PTP (proficiency testing provider): organization which takes responsibility for

all tasks in the development and operation of a proficiency testing scheme

(4) PTI (proficiency test item): sample, product, artefact, reference material, piece

of equipment, measurement standard, data set or other information used for

proficiency testing

5. Types of proficiency testing schemes and interlaboratory comparisons

which are available for IAJapan

5.1 Proficiency testing schemes which are available in the assessment and

accreditation process

In accreditation/registration programs operated by IAJapan that

accredit/register testing laboratories (including specified measurement

laboratories; the same definition shall apply hereinafter), calibration laboratories

and reference material producers, the following PT schemes are available in the

assessment and accreditation process:

a) PT provided by IAJapan as a PTP

b) PT provided by ABs as PTPs which are signatories to the ILAC MRA or

APLAC MRA, e.g. Japan Accreditation Board (JAB)

c) PT and ILC designated or hosted by international or regional organizations,

e.g., APLAC (Asia Pacific Laboratory Accreditation Cooperation), IAAC (Inter



American Accreditation Cooperation), IRMM (Institute for Reference

Materials and Measurements), IFCC (International federation of Clinical

chemistry), and JCTLM (Joint Committee on Traceability in Laboratory

Medicine)

d) PT provided by PTPs other than the organization from a) to c) of this

sub-clause. Such PT shall be confirmed in advance by IAJapan, regarding

the appropriateness of the descriptions in their reports and compliance of

such PT with the essential requirements of ISO/IEC 17043.

Note: As for a PT scheme provided by a PTP accredited by an ILAC

MAR-signatory AB, it shall be deemed that IAJapan has confirmed that such PT

scheme conforms the requirements in d) above.

Such PT schemes are typically paid services for which the participants shall pay fees

to international organizations, regional organizations or PTPs that manage/provide

such PT schemes; such fees include costs relating to PTIs, and costs relating to

measurements conducted to determine homogeneity, stability, and assigned values

and associated measurement uncertainty of PTI measurands.

5.2 Interlaboratory comparisons which are available in the assessment and

accreditation process

In any testing laboratory, calibration laboratory or reference material producer

accreditation/registration program operated by IAJapan, if a PT scheme

stipulated in 5.1 above is unavailable or inappropriate, the following ILCs may be

used in the assessment and the accreditation process:

A) CIPM and RMO (e.g., APMP) key comparisons and supplementary

comparisons, and bilateral comparison with particular National Metrology

Institute

B) ILC that have been organized for purposes other than PT. In such case,

IAJapan shall confirm in advance that satisfactory evidences presented by the

laboratories/producers who participated in such comparison can be

demonstrated the technical competences of such organizations.

Note: ILAC P9:11/2010 clause 4.1 includes some examples of ILCs as 5.2 B), but not

be limited to, the following:

- to evaluate the performance characteristics of a method;

- to characterise a reference material;

- to compare results of two or more laboratories on their own initiative.



6. Basic policy on proficiency testing

6.1 Basic policy on proficiency testing participation plan

Each testing laboratory, calibration laboratory or reference material producer

accredited/registered by IAJapan or applying for the IAJapan

accreditation/registration shall formulate a documented “proficiency testing

participation plan” satisfying either of (1) and (2) below and be assessed by

IAJapan’s assessment, reassessment and surveillance.

(1) “The record” that is appropriate to the scope of accreditation and is regularly

reviewed in response to changes in staffing, methodology, instrumentation, etc.

Individual PT schemes to be participated by the organization shall be set in such

plan as further and ongoing activities not longer than four years, in principle;

activities to be performed prior to accreditation shall also be included.

(2) “Documented descriptions” stating that the laboratory/producer shall participate

in a PT at least once in every four years for each of major sub-disciplines which are

appropriate to the scope of the accreditation/registration; such sub-disciplines

include all classifications of accreditation/registration and classification of testing

methods according to the characteristics of such testing methods. Revision of

such descriptions shall be accompanied by the description of the ground (reason)

for the revision.

Note 1: An example of a proficiency testing participation plan is shown in Appendix

B. Such “proficiency testing participation plan” may be titled with any name

and formulated in any format. Typically, the record stipulated in (1) may

be an independent record or a record integrated with another quality

assurance plan; the descriptions stipulated in (2) may be chapters and

sections of a quality manual, covering the quality assurance of testing and

calibration results or descriptions included in other regulations or manuals.

Note 2: If the interval of the revision of the proficiency testing participation plan is

set longer than 4 years, or if an organization failed to take PT in accordance

with the predetermined interval, the ground (reason) for such longer

interval or failure to take PT shall be also assessed in addition to the

descriptions contained in the plan, and the organization shall be required to

present an objective reason therefore.

6.2 Basic policy on participation for proficiency testing

(1) A testing laboratory, calibration laboratory or reference material producer

applying for the IAJapan accreditation/registration shall, before the accreditation,

participate in the PT schemes appropriate to the scope of the accreditation as

stipulated in 5.1 above or ILCs as stipulated in 5.2 A) above, and generate

satisfactory results in such PT or ILC.



(2) An IAJapan-accredited/registered testing laboratory, calibration laboratory or

reference material producer shall participate in the PT schemes as stipulated in

5.1 above or ILCs as stipulated in 5.2 A) above, in accordance with the documented

proficiency testing participation plan assessed by IAJapan in advance, and shall

generate satisfactory results in such PT or ILC.

Note 1: “Participate in PT schemes appropriate to the scope of the accreditation as

stipulated in 5.1 above or ILCs as stipulated in 5.2 A) above, and generate

satisfactory results” shall mean that the results of those are determined to be

“satisfactory” or that ILC results are determined by technical experts as

“satisfactory,” or shall mean that, where PT or ILC results of an participant

had previously been determined as “unsatisfactory” or “questionable”, the

participant identified the cause for such unsatisfactory results and took

necessary corrective actions and, as a result of such corrective actions, and by

the presentation of appropriate evidence, it is validated that the participant

has satisfactory technical competence.

Note 2: PT and ILC not only validate the technical competence of testing laboratories,

calibration laboratories or reference material producers but also are

important tools to maintain and enhance the performance quality of these

organizations.

Note 3: “Appropriate to the scope of accreditation” differs depending on

accreditation programs and depending on testing laboratories/calibration

laboratories/reference material producers. For details, please refer to 7.1 to

7.4 below.

6.3 Basic policy on notification of poor performance in proficiency testing to IAJapan,

excluding the proficiency testing which is provided by IAJapan

In PT schemes stipulated in 5.1 b) to d) above, if the results of PT schemes by an

IAJapan-accredited testing laboratory/calibration laboratory/reference material

producer are determined to be “questionable” or “unsatisfactory,” such results

shall be promptly notified to IAJapan. Such organization shall conduct a proper

investigation to identify the cause of such questionable or unsatisfactory results,

and shall make necessary corrective actions related to such “unsatisfactory”

results.

Note 1: If the PT schemes are those stipulated in 5.1 c) or d), and if it is ensured that

results of such PT schemes are notified from PTPs to IAJapan, the notice

stipulated in 6.3 is not necessary.

Note 2: If the PT results of a participating organization was determined to be

“unsatisfactory” and if such organization failed to conduct appropriate

investigation to identify the cause of such unsatisfactory results or to make

necessary corrective actions, IAJapan may suspend or withdraw the

accreditation/registration of such organization.



7. Application policy on proficiency testing requirements for individual

accreditation program

The following are policies for applying PT requirements to each

accreditation/registration program, in accordance with the policies on PT

stipulated in Section 6 above.

7.1 Application policy on proficiency testing requirements for MLAP (out of scope of

international MRA)

(1) Specified measurement laboratories applying for the MLAP accreditation or

MLAP-accredited specified measurement laboratories shall participate in PT

schemes stipulated in 5.1 a), or PT schemes stipulated in 5.1 d) and designated by

IAJapan, in accordance with their respective internal standards for monitoring

validity of measurement results stated in measurement certifications, under the

provisions of Paragraph 1, Clause 10 of the Ministerial Announcement.

(2) If a specified measurement laboratory applying for the MLAP accreditation or

MLAP-accredited specified measurement laboratory uses a contractor (i.e.

commission part of its operational processes to a third party), and if requested by

an AB, such specified measurement laboratory shall agree with such contractor

that the contractor participates in PT schemes, under the provisions of Paragraph

3, Clause 3, Sub-clause 3 (ii) of the Ministerial Announcement.

Note: In 7.1 above, the appropriateness of the report for the “PT schemes stipulated

in 5.1 d) and designated by IAJapan” shall be deemed to have been verified by

IAJapan.

7.2 Application policy on proficiency testing requirements for JCSS

(1) A calibration laboratory applying for the JCSS accreditation/registration shall,

before the accreditation/registration, participate in the PT stipulated in 5.1 for the

calibration method class (type of service) subject to such application, and generate

satisfactory results in such PT.

(2) A JCSS-accredited laboratory shall formulate a PT participation plan, participate

in the PT stipulated in 5.1 on an ongoing basis and in accordance with such plan,

and generate satisfactory results in such PT. Such JCSS-accredited laboratories

shall follow the policy stipulated in 6.3.

A JCSS-accredited laboratory shall participate in the PT at least once every four

years for each calibration method class for which such laboratory is accredited in

principle, and generate satisfactory results in such PT.

(3) A JCSS-registered laboratory should formulate a PT participation plan, as part of

its quality assurance activities for testing/calibration results as defined in clause

5.9 of ISO/IEC 17025:2005, and participate, on an ongoing basis, in the PT

stipulated in 5.1 in accordance with such plan. If a JCSS-registered laboratory



participates in such PT, the laboratory shall generate satisfactory results and

follow the policy stipulated in 6.3.

Note 1: Preferably, a calibration laboratory applying for the JCSS

accreditation/registration should take into account the following matters with

regard to the document specified in Article 91 (iv) of the Measurement Act

which is required to be submitted along with the application:

1) Before applying, check the homepage of IAJapan to find out if there exists any

PT scheme specified in clause 5.1 above;

2) If it is found that there is no appropriate PT scheme provided, consult with

IAJapan before applying for the JCSS accreditation/registration about the

feasibility of the implementation of the alternative means of PT specified in

clause 8 of this policy.

3) Based on the result of such consultation, implement the alternative means of

PT.

Note 2: In 7.2 (1) to (3) above, the appropriateness of the report for the PT stipulated

in 5.1 d) is deemed to have been verified by IA Japan if it is ensured in

advance that results of such PT are notified from PTPs to IAJapan.

Note 3: For matters relating to use of alternative means in a “calibration method

class” where a suitable or practical PT is not available, refer to 8. in this

policy document. If there is any “calibration method class” found to have no

suitable or practical PT available, a JCSS-accredited/registered calibration

laboratory should agree with IAJapan regarding the use of an alternative

means by which such laboratory’s performance is evaluated and monitored,

preferably by the time of its first accreditation/registration. For an example of

such agreement concerning the alternative means for JCSS, refer to Appendix

C.1.

7.3 Application policy on proficiency testing requirements for JNLA

(1) A testing laboratory applying for the JNLA accreditation shall, before the

accreditation and for each field pertaining to such accreditation, participate in the

PT stipulated in 5.1 if available, for at least one testing method class subject to

such application, and generate satisfactory results in such PT.

(2) A testing laboratory applying for the JNLA registration should, as part of its

quality assurance activities for testing/calibration results as defined in clause 5.9

of ISO/IEC 17025:2005, participate in the PT stipulated in 5.1 if available, before

the registration and for each field pertaining to such registration, for at least one

testing method class subject to such application. If a testing laboratory applying

for the JNLA registration participates in such PT, it shall generate satisfactory



results in such PT.

(3) A JNLA-accredited testing laboratory shall formulate a PT participation plan

stipulated in 6.1 above, participate in the PT stipulated in 5.1 if available, on an

ongoing basis, and generate satisfactory results in such PT. Such

JCSS-accredited laboratories shall follow the policy stipulated in 6.3. A

JNLA-accredited testing laboratory shall, if there are more than two PTs in the

same accreditation field provided for the testing method class pertaining to such

accreditation, except in cases where there are special reasons, participate in all of

such PTs and generate satisfactory results in such PTs.

(4) A JCSS-registered laboratory should formulate a PT participation plan stipulated

in 6.1 above, as part of its quality assurance activities for testing/calibration

results as defined in clause 5.9 of ISO/IEC 17025:2005, and participate in the PT

stipulated in 5.1 if available, on an ongoing basis. If a JCSS-registered laboratory

participates in such PT, the laboratory shall generate satisfactory results and

follow the policy stipulated in 6.3.

Note 1: In 7.3 (1) to (4) above, the appropriateness of the report for the PT stipulated

in 5.1 d) is deemed to have been verified by IA Japan if it is ensured in

advance that results of such PT are notified from PTPs to IAJapan.

Note 2: The “cases where there are special reasons” specified in 7.3 (3) above apply

to situations where a JNLA-accredited testing laboratory has already

participated (or plans to participate) in other equivalent PTs or ILCs.

Note 3: For matters relating to use of alternative means for the field, class or test

item where a suitable or practical PT is not available, refer to 8. in this policy

document. An example of a field where the PT is not practical is a case for

which JNLA demonstrative product testing is conducted at the time of on-site

assessment and the assessment team confirms that the laboratory has

sufficient technical competence based on the qualitative evaluation of the

testing procedures or quantitative evaluation of the test results. Moreover, a

PT may not be provided if there are not enough participants. In such a case,

a testing laboratory applying for the JNLA accreditation/registration or

JNLA-accredited/registered testing laboratory should agree with IAJapan

regarding the use of an alternative means by which such laboratory’s

performance is evaluated and monitored, preferably by the time of its first

accreditation/registration. For an example of such agreement concerning the

alternative means for JNLA, refer to Appendix C.2.



7.4 Application policy on proficiency testing requirements for ASNITE

(1) A testing laboratory, calibration laboratory or reference material producer

applying for the ASNITE accreditation shall, before the accreditation, participate

in the PT stipulated in 5.1 or the ILC stipulated in 5.2 A), for at least one testing,

calibration or measurement method class which is subject to such application, out

of all accreditation-related calibration or measurement method classes, or testing

method classes (which are grouped based on characteristics of testing methods),

and generate satisfactory results in such PT or ILC.

(2) An ASNITE-accredited laboratory shall formulate a PT participation plan

stipulated in 6.1 above, participate in the PT stipulated in 5.1 or the ILC

stipulated in 5.2 A) on an ongoing basis and in accordance with such plan, and

generate satisfactory results in such PT or ILC. Such JCSS-accredited

laboratories shall follow the policy stipulated in 6.3.

Note 1: In 7.4 (1) and (2) above, the appropriateness of the report for the PT

stipulated in 5.1 d) is deemed to have been verified by IAJapan if it is ensured

in advance that results of such PT are notified from PTPs to IAJapan.

Note 2: For matters relating to use of alternative means in a field where a suitable or

practical PT is not available, refer to 8. in this policy document. Examples of

fields where PT is not practical are the Accreditation Class “Information

Technology – Common Criteria Evaluation” and several testing method

classes in the environmental field. In the “Information Technology –

Common Criteria Evaluation” class, alternative means to evaluate and

monitor the performance of an testing laboratory applying for the ASNITE

accreditation or ASNITE-accredited testing laboratory (i.e. monitoring of

results of evaluation performed by an evaluator who achieved satisfactory

results in a demonstrative evaluation performed for another purpose) are

defined in general requirements for ASNITE accreditation. In the

environmental field, a testing laboratory applying for the ASNITE

accreditation or ASNITE-accredited testing laboratory should agree with

IAJapan regarding the use of an alternative means by which such

laboratory’s performance is evaluated and monitored (such as evaluation of

ILC results as stipulated in 5.2 B where the type and method of comparison is

defined), preferably by the time of the first accreditation. For an example of

such agreement concerning the alternative means for ASNITE, refer to

Appendix C.3.



8. IAJapan alternative means policy on the areas for which suitable

proficiency testing does not exist or is not practical

(1) If the PT stipulated in 5.1 or the ILC stipulated in 5.2 A) does not exist, or

if, where a similar PT exists, the use of such similar PT is not appropriate

because PTIs subject to such similar PT are significantly different from

items generally tested, calibrated or measured by the laboratory/producer,

or if enormous costs are needed just for determining assigned values, or in

any other case where an appropriate PT scheme is not available or available

PT schemes are not practical for a certain field, the laboratory/producer

shall discuss and agree with IAJapan regarding a suitable alternative

means to implement in place of participation in PT schemes to evaluate and

monitor such organization’s performance.

(2) The agreement in (1) above shall be, in principle, executed in writing

between the program manager of IAJapan and a representative of the

laboratory/producer.

(3) If the agreed alternative means as described above is implemented and the

results of such alternative means are evaluated to be “questionable” or

“unsatisfactory,” in accordance with the policy stipulated in 6.3 above, the

laboratory/producer shall notify such results to IAJapan and conduct an

investigation to identify the cause of such results, and make necessary

corrective actions if necessary.

Note 1: Such alternative means to be agreed shall include but not be limited to the

following:

- Bilateral comparison between a given NMI (national metrology institute,

as defined in 5.2 A) and a non-NMI organization; and

- Where it is impossible or impractical to implement the PT stipulated in 5.1,

ILC as stipulated in 5.2 B) or other similar method implemented as an

alternative means

Note 2: For an example of written agreement between the program manager of

IAJapan and a representative of a laboratory, refer to Appendix C.

Note 3: When implementing ILCs for measurement comparison schemes as an

alternative means to JCSS PT, the following shall be noted:

- In principle, procedures and test items that enable the realization of

CMCs shall be selected;

- A calibration certificate issued by a reference laboratory (an appropriate

NMI or accredited calibration laboratory) shall be, in principle, within

the accreditation scope of CIPM MRA or JCSS, ASNITE or signatories

to ILAC/APLAC MRA;

- In principle, CMCs of a reference laboratory shall be smaller than those

of a participating calibration laboratory and the performance shall be

able to be evaluated appropriately by En number; nE ;

- In principle, a participating calibration laboratory shall perform the



measurement (calibration) before the reference laboratory and notify

the results of such measurement to IAJapan.

9. IAJapan information providing policy regarding proficiency testing

participation plan

IAJapan provides the following information in order to assist testing

laboratories/calibration laboratories/reference material producers in

formulating their PT participation plans.

9.1 Listings and direction of proficiency testing providers

IAJapan provides the latest listing of or direction on PTPs on IAJapan

webpage for each accreditation/registration program. For details, refer to

respective IAJapan webpage.

Appendix D shows a list of PTPs which IAJapan has had used their PT

schemes until the date of enforcement of this policy document.

Note: As for PT schemes to be provided by PTPs listed in Appendix D on and after

the date of enforcement of this policy document, confirmation by IAJapan

stipulated in 5.1 d) is required.

9.2 Consideration for selecting suitable proficiency testing schemes and suitable

participation frequency

Unlike in European/American countries, there are not many PT schemes

available in the Japanese market from which laboratories/producers can choose.

Accordingly, the considerations described here are just for information.

(1) In the calibration field (JCSS and ASNITE), if a PT scheme provides a test

with different measuring instruments within the same calibration method class,

a laboratory can objectively verify its technical competence in that class as a

whole, by participating in the PT performed by using Type A measuring

instrument, and then participating in the same PT performed by using Type B

measuring instrument. It is highly preferable that a laboratory comply with

the participation frequency stipulated in the technical application guides for

respective fields (if the frequency is stipulated in such guides).

(2) In the testing fields (JNLA and ASNITE), the participation frequency may

differ depending on the conditions of respective fields. For example, PT

participation at a frequency of once in each four years may be sufficient for

general JNLA product testing. However, APLAC PT006 Issue No. 2, 09/10

establishes PT frequency benchmarks:10 times/year for clinical fields (for each

area), twice a year for biological/chemical fields (environment and inorganic

analysis) and once a year for forensic medicine/veterinary/chemical (others)

fields. In such special testing fields, accredited testing laboratories should



participate in PT on an ongoing basis at a frequency appropriate to ensure the

quality of their own testing results, preferably in accordance with such PT

frequency benchmarks.

9.3 Guidance on how to analyse and formulate the proficiency testing needs (ILAC

P9:11/2010 clause 4.5)

- The consideration of the compatibility of PTI type and presentation provided by

PTP, with those that are most commonly handled by the laboratory or

reference material producers in its day to day work.

- PT schemes may be used not only as tools for evaluating laboratory

performance but also as educational and risk management tools, and may

also be used as part of comprehensive quality assurance procedures of

laboratories.

- The activities other than PT participation may be considered as providing

useful information on the capability of the laboratory. For example,

characterisation of reference materials, information obtained through

method validation activities etc.

10. IAJapan information providing policy for proficiency testing providers

10.1 Information providing from IAJapan

IAJapan may provide inputs to assist PTPs in the formulation of their PT

schemes where IAJapan uses the information from those schemes in accordance

with ILAC P13:10/2010 clause 2.1. This input shall not include the provision

of any advice or assistance to the PTP as a consulting service, and shall be

limited to input as a stakeholder in relation to the use of PT to provide

information concerning the competence of laboratories or reference material

producers.

Such inputs shall be stated in an impartial way, generally by publication on

webpage of IAJapan for individual accreditation/registration programs, so that

they do not conflict with the fairness of IAJapan.

For details, refer to respective IAJapan webpage.

10.2 Attendance in the committee of proficiency testing providers by IAJapan

A representative from IAJapan may participate and express opinions, as a

stakeholder who uses PT schemes, in committees established by PTPs for the

purposes of evaluation of performance (ISO/IEC 17043 4.7.2.1), authorization of

the final reports (4.8.1 of the same standard) and, as necessary, planning of the

PT schemes (4.4.1.2 of the same standard).



If a PTP wishes to appoint an IAJapan representative as a member of any of

such committees, the PTP shall send an appointment request to such IAJapan

representative and the President of the National Institute of Technology and

Evaluation (hereinafter “NITE”), in accordance with the relevant regulations

established by NITE.

10.3 Lending of proficiency testing items to proficiency testing providers, the items

which are furnished by IAJapan

In the calibration fields, IAJapan furnishes certain artifacts (PTIs) that may

be used in proficiency testing. If a PTP wishes, it may borrow such PTIs from

IAJapan for the purpose of providing its PT schemes, by entering necessary

information in the “PT Artifacts Lending Permission” issued by IAJapan and

submitting two copies of the permissions, in accordance with the relevant

regulations established by IAJapan.



Supplementary provisions (effective date)

1. This policy document applies after August 1, 2011.

Supplementary provisions (Transitional measure)

1. Normative referenced in 3. in this policy document, JIS Q 0043-1:1998 and JIS

Q 0043-2:1998 shall be applied only until JIS Q 17043 is established and these

standards are abolished.

2. If, before the effective date of this policy, an accredited testing laboratory,

calibration laboratory or reference material producer has had management

system-related documents which refer to clauses relating to PT of respective

general requirements relating to JCSS, JNLA or ASNITE referenced in 3. in

this policy document, such organization shall be deemed to have provisions

complying to the relevant requirements stipulated in this policy document,

during the period from the effective date of this policy document to March 31,

2012.

Supplementary provision (effective date)

1. This policy document applies after May 1, 2012.


1. This policy document applies after September 2, 2013.


1. This policy document applies after October 1, 2014.



Appendix A (Informative) Summary of international and regional

requirements on proficiency testing

A.1 Summary of international PT requirements based on ILAC P9

According to ILAC P9:11/2010 clause 4.2, the minimum PT activity according to

a laboratory’s (where relevant) scope is:

- Evidence of satisfactory participation prior to gaining accreditation where PT is

available and appropriate;

- Further and ongoing activity that is appropriate to the scope of accreditation

and consistent with the PT participation plan.

And according to also ILAC P9:11/2010 clause 4.3, any requirements regarding

the minimum level and frequency of participation in PT by accredited laboratories,

including the need for a PT participation plan.

- The PT participation plan has been formulated by the laboratory or inspection

body (if relevant) and is regularly reviewed in response to changes in staffing,

methodology, instrumentation etc;

An accredited/registered testing or calibration laboratory shall need supportive

information so that it can identify its needs relating to participation in PT

schemes and formulate a PT participation plan. According to clause 4.5, ILAC

P9:11/2010, ABs may provide the following supportive information:

- listings or direction to possible sources of PT, and considerations for selecting

suitable programs;

- guidance on how to analyse and formulate the particular PT needs of the

laboratory

A.2 Summary of regional PT requirements based on APLAC TC008

According to APLAC TC008 Issue No. 4, 08/13 clause 3.11 d), the PT activity of

reference material producer is;

- When the reference material producer performs a test or calibration that

significantly affects the uncertainty of the assigned property value of a reference

material, the reference material producer shall participate in the proficiency

testing programs as required in ILAC P9.

- When the reference material producer subcontracts any test or calibration, it

shall require such subcontractor to participate in the proficiency testing

program as required in ILAC P9.

- If there is no proficiency testing program available to the subcontractor, it shall

take into consideration demonstrating its competence through other means

(such as using a measurement audit or samples for verification).



Appendix B (Informative) Example of proficiency testing participation plan

B.1 Example of proficiency testing participation plan for JCSS (record)

5-Year Proficiency Testing Participation Plan

JCSS Calibration Branch, Company AAA

Registration Accreditation

Classes (Scope of

Accreditation)

Calibration method

class

Measuring instrument

type

Scheduled participation year

20X

V

20X

W

20X

X

20X

Y

20X

Z

Length Wavelength

measuring

instrument

Wavelength of

633 nm He-Ne

laser

Length

Measuring

Instrument

Gauge blocks

Standard

Scale

Mass Weight Weight

Scale Non-Automatic

Electronic

Weighing

Instruments

Temperature Contact

type

thermomete

r

Resistance

thermometer

Thermocouple

s

Thermometer

with indicator

*1. This plan will be reviewed once in a year based on the results of internal audit

and management review.

*2. If the Company failed to participate in PT as scheduled in this Plan, it must

record the reason for the failure (e.g., JCSS PT programs were not

implemented as scheduled in JCSS PT Schedule for 20XV disclosed in the

IAJapan website.)

Prepared by Examined by Approved by

Person

in

Charge

Calibration

Staff

Technical

Manager

Technical

Manager

Date 20XV/mm/dd 20XV/mm/dd 20XV/mm/dd

Seal or

Sign

Kukeko Kaki Ueo AI Ueo AI

Seal Sea

l

Seal



* Note for preparing the plan: If records are entered in a paper format, the dates

at the bottom of this page (at least the date for the technical manager) shall be

written by hand pending and seal impressions of persons in charges shall be

affixed physically. If records are entered in an electromagnetic format and if

the approval date is significantly different from the file update date, the reason

for the difference shall be disclosed at the time of the IAJapan assessment to

prove that the difference is justifiable and that no alteration has been made to

such record.

B.2 Example of proficiency testing participation plan for JNLA (documented

descriptions)

5.9 Quality assurance of testing results

5.9.1 To verify that the JNLA product testing performed by the JNLA laboratory

of XXX Testing Center is technically appropriate, the following quality

assurance programs must be implemented for testing results:

(1) In the JNLA civil engineering/architectural field, a laboratory must

participate in a PT or ILC conforming to the IAJapan Policy on Proficiency

Testing (URP24), for aggregate testing and concrete/cement compression

testing, once in every four years.

(2) Descriptions omitted (it is preferable that provisions similar to (1) above are

described for each JNLA field.)



Appendix C (Informative) Example of alternative means which is discussed

and agreed between IAJapan and laboratory’s representative

C.1 An Example of the Confirmation on Alternative Means In Place of Proficiency

Testing (JCSS)

Confirmation on Alternative Means In Place of Proficiency Testing

No. 1/1

In accordance with the IAJapan Policy on Proficiency Testing (URP24), the program

manager of IAJapan and the representative of the laboratory/producer agree that the

alternative means shall be used to evaluate and monitor the organization’s

performance in a field where suitable PT is not available or use of available PT is not

practical, in place of PT participation, as stipulated below. Once the alternative

means is (are) finally agreed between the IAJapan and the organization, the

organization shall conduct an ILC and/or other testing, calibration and measurement

activities by using and following such alternative means.

During the next assessment (re-assessment or surveillance), the results of testing,

calibration or measurement activities conducted by using such alternative means shall

be evaluated by IAJapan on site.

Identification number and name of

laboratory/producer to be assessed

C NNNN

JCSS Calibration Branch, Company AAA

Accreditation Classes (Scope of Accreditation)

Temperature (contact type thermometer)



No Relevant

Requirements

Alternative Means

1 ISO/IEC

17025:2005

5.9.1 b)

From FY yy onwards, if there is no PT for a

temperature calibration system is provided, an ILC for

such system shall be conducted at the frequency of every

4 years from FY yy onwards.

The measurement of a temperature calibration system

equivalent to the one to be calibrated which is owned by

the laboratory to be assessed shall be conducted at 0°C, a

temperature close to 100°C and every other point

obtained by raising or lowering the temperature by 100°C

from the said temperature close to 100°C. Then, JCSS

calibration of these temperature points measured shall be

requested to an international MRA-accredited JCSS

laboratory having smaller CMCs than the laboratory to

be assessed, and using the measurement of such results

as reference value, the performance shall be evaluated

based on En number specified by e) in B.3.1.3 of Appendix

B, ISO/IEC 17043. nE

Program manager and laboratory representative have agreed on the

above-mentioned alternative means.

Date

Laboratory representative Ueo Ai

Program manager Suseso Sashi

Note to assessor: Your signature must be placed on a report that is not easily rewritable.

Cross out the blank page below. Pages must be serially numbered.

* Note for preparing the document: This confirmation shall only cover the classes

for which alternative means are agreed. No agreement is necessary for classes

for which the laboratory/producer participates in available PT schemes.

* Details of the alternative means (frequency, evaluation method, evaluation

criteria, etc.) shall be described in the Alternative Means box.

* The format of this confirmation may be revised without notice. Accordingly, a

laboratory/producer may be requested to use a different format for confirmation

on alternative means.




Testing (JNLA)


No. 1/1












Identification number and name of

laboratory/producer to be assessed

S NNNN

JNLA laboratory, XXX Testing Center

Accreditation Classes (Scope of Accreditation)

Compressive strength testing of XXX Material,

tensile testing of XXX Material, flexural properties

testing of XXX Material



No Relevant

Requirements

Alternative Means

1 ISO/IEC

17025:2005

5.9.1 b)

For the tensile testing for XXX Material, the

laboratory shall conduct an ILC with the JNLA

Testing Center of XXX Testing Institute, at the

frequency of once every Y years. Samples shall be

provided by either of the laboratories in turn. The

performance shall be evaluated by a) or b) in B.3.1.3

of Annex B, ISO/IEC 17043, and the criteria for the

evaluation shall be agreed in advance between the

laboratories.



Date


Program manager Tsuteto Tachi














Testing (ASNITE)


No. 1/1












Identification number

and name of

laboratory/producer to

be assessed

E NNNN

Environmental Testing Laboratory, XX Analysis

Center

Accreditation Classes

(Scope of Accreditation)

Environment (air): Titration (volumetric analysis)



No Relevant

Requirements

Alternative Means

1 ISO/IEC

17025:2005

5.9.1 a)

For a period until an ILC for this accreditation

category can be performed, with regard to the

methods for determination of oxygen in flue gas

(JIS K 0301:1998) (chemical analysis methods using

an Orsat gas analyzer), an internal quality control

(measurement) using oxygen standard gas

characterized ( %, % and %) shall be

conducted XX per year. The performance shall be

evaluated by a) or b) in B.3.1.3 of Annex B, ISO/IEC

17043, and the criteria for the evaluation shall be

based on the Requirements of (RPNN-EC).

If there is any testing laboratory which has been

accredited in this accreditation category, an ILC

with such laboratory(s) shall be conducted, and the

alternative means shall be considered again.



Date


Program manager Suseso Sashi













Appendix D (Informative) List of proficiency testing providers which were

utilized by IAJapan

The following tables list proficiency testing providers (PTPs) whose

conformity to ISO/IEC 17043 has been confirmed by IAJapan and whose PT

schemes have been used by IAJapan before the date of enforcement of the latest

edition of this policy document, for each accreditation/registration program:

D.1 MLAP

Scope of accreditation Name of PTP

Concentration of Dioxin JEMCA (Japan Environmental Measurement

and Chemical Analysis Association) Note）

Note: In accordance with the note to 7.1 of this policy document, no verification

by IAJapan is necessary for the MLAP proficiency testing schemes provided

by this PTP.

D.2 JCSS


Length, Force, Acoustics Japan Quality Assurance Organization (JQA)

Mass The Japan Measuring Instruments Federation

(JMIF)

Temperature, Electricity

(Direct Current and Low

Frequency), Mass, Length

Japan Electric Meters Inspection Corporation

(JEMIC)

Electricity (Direct Current

and Low Frequency),

Electricity (High Frequency)

The Japan Electronics and Information

Technology Industries Association (JEITA)

Mass Japan Accreditation Board (JAB) (Note)

Electricity (High Frequency) Agilent Technologies

Length, Mass, Electricity

(Direct Current and Low

Frequency), Electricity (High

Frequency), Flowrate

Korea Laboratory Accreditation Scheme

(KOLAS) (Note)

Note: In accordance with the provision in 5.1 b) of this policy document, no

verification by IAJapan is necessary for the proficiency testing schemes

provided by JAB and KOLAS (who are signatories to ILAC/MRA) in the

capacity of PTPs.



D.3 JNLA

Testing Field Name of PTP

Multiple areas Japan Accreditation Board (JAB) (Note)

Korea Laboratory Accreditation Scheme

(KOLAS) (Note)

Japan Testing Centre for Construction Materials

(JTCCM)

Japan Textile Products Quality and Technology

Centre (QTEC)

Civil Engineering and

Architecture

Taiheiyo Consultant Co., Ltd.

Antimicrobial Activity Japan Textile Evaluation Technology Council

(JTETC)

Society of Industrial technology for Antimicrobial

Articles (SIAA)

Electrical Appliances Safety National Institute of Advanced Industrial Science and

Technology (AIST)

Japan Electrical Safety and Environment

Technology Laboratories (JET)

Note: In accordance with the provision in 5.1 b) of this policy document, no

verification by IAJapan is necessary for the proficiency testing schemes

provided by JAB and KOLAS (who are signatories to ILAC/MRA) in the

capacity of PTPs.

D.4 ASNITE


Test: Multiple areas Japan Environmental Measurement and

Chemical Analysis Association (JEMCA)



Appendix E (Informative) Determination of the performance of proficiency

testing result

E.1 Choice of method of determining the assigned value (ISO 13528 5.1) Omission

Omitted



IAJapan Policy on Proficiency Testing (The 4th edition)

Revision Notes

1. Reason for Revision

A revision to delete the description concerning a measurement audit is made based

on the fact that a measurement audit can be deemed as a type of proficiency testing

(A.2 (e) of Annex A, JIS Q 17043) and the implementation of a measurement audit by

IAJapan is limited through the active use of alternative means of proficiency testing.

With regard to JCSS, a revision is made to clarify the registration/accreditation

(application) category which requires the registered/accredited (applied) laboratory

to participate in proficiency testing.

With regard to the alternative means of proficiency testing, revisions are made to

change the personnel of IAJapan executing a written confirmation and to prescribe

rules for the laboratory producing unsatisfactory results.

2.Main Revisions

The definition of measurement audit is deleted (clause 4). Concurrently, any

description concerning measurement audit is deleted from the main context

(except for A.2 of Appendix A).

Requirements are listed in a box and those that are not are listed outside the box

as notes (clause 6.3, 7.2, 7.3 and 7.4).

With regard to JCSS, it is clearly stated that laboratories applying for

accreditation/registration or accredited laboratories, in principle, are required to

participate in proficiency testing for each “calibration method class” pertaining to

the accreditation/registration which has been applied for or accredited (clause 7.2

(1) and (2)).

With regard to the alternative means of proficiency testing, it is specified that the

personnel of IAJapan executing a written confirmation with the laboratory is a

relevant program manager of IAJapan, in principle (clause 8 (2)). Concurrently,

the columns for the date of assessment and the name of assessors are deleted from

the example of the confirmation form (C.1, C.2 and C.3 of Appendix C).

The measures are described that are to be taken in the case where the result of

the alternative means of proficiency testing is evaluated as unsatisfactory (clause

8 (3)).

A statement to the effect that the procedures and test items that enable, in

principle, the realization of CMCs shall be selected is added to the considerations

provided for the implementation of the alternative means of proficiency testing for

JCSS (Note 3 in clause 8).

With regard to the calibration field, a consideration for the selection of proficiency

testing to participate in is revised (clause 9.2 (1)).



Following the revision of APLAC TC008 (APLAC Requirements for and Guidance

on the Accreditation of a Reference Material Producer), the content of the outline

of proficiency testing provided in this policy document is revised (A.2 of Appendix

A).

The list of proficiency testing providers which were utilized by IAJapan is

renewed (D.2, D.3 and D.4 of Appendix D).

Other additions or omissions of words and phrases are made throughout (overall).

*Revisions accompanying content changes are indicated by wavy line.

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