IAJapan Policy on Proficiency Testing

Transcription

1 URP24-04 IAJapan Policy on Proficiency Testing 1 / 32 URP24-04 IAJapan Policy on Proficiency Testing (4th edition) July 8, 2014 International Accreditation Japan (IAJapan) National Institute of Technology and Evaluation (NITE)

2 URP24-04 IAJapan Policy on Proficiency Testing 2 / 32 Contents 1. Purpose Scope Normative reference Terminology Types of proficiency testing schemes and interlaboratory comparisons which are available for IAJapan Proficiency testing schemes which are available in the assessment and accreditation process Interlaboratory comparisons which are available in the assessment and accreditation process Basic policy on proficiency testing Basic policy on proficiency testing participation plan Basic policy on participation for proficiency testing Basic policy on notification of poor performance in proficiency testing to IAJapan, excluding the proficiency testing which is provided by IAJapan Application policy on proficiency testing requirements for individual accreditation program Application policy on proficiency testing requirements for MLAP (out of scope of international MRA) Application policy on proficiency testing requirements for JCSS Application policy on proficiency testing requirements for JNLA Application policy on proficiency testing requirements for ASNITE IAJapan alternative means policy on the areas for which suitable proficiency testing does not exist or is not practical IAJapan information providing policy regarding proficiency testing participation plan Listings and direction of proficiency testing providers Consideration for selecting suitable proficiency testing schemes and suitable participation frequency Guidance on how to analyse and formulate the proficiency testing needs (ILAC P9:11/2010 clause 4.5) IAJapan information providing policy for proficiency testing providers Information providing from IAJapan Attendance in the committee of proficiency testing providers by IAJapan Lending of proficiency testing items to proficiency testing providers, the items which are furnished by IAJapan Supplementary provisions (effective date)... 18

3 URP24-04 IAJapan Policy on Proficiency Testing 3 / 32 Appendix A (Informative) Summary of international and regional requirements on proficiency testing Appendix B (Informative) Example of proficiency testing participation plan Appendix C (Informative) Example of alternative means which is discussed and agreed between IAJapan and laboratory s representative Appendix D (Informative) List of proficiency testing providers which were utilized by IAJapan Appendix E (Informative) Determination of the performance of proficiency testing result (omitted)... 30

4 URP24-04 IAJapan Policy on Proficiency Testing 4 / 32 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.

5 URP24-04 IAJapan Policy on Proficiency Testing 5 / 32 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 Statistical methods for use in proficiency testing by interlaboratory comparisons ISO/IEC Conformity assessment - Vocabulary and general principles ISO/IEC General requirements for the competence of testing and calibration laboratories ISO/IEC 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 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)

6 URP24-04 IAJapan Policy on Proficiency Testing 6 / 32 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

7 URP24-04 IAJapan Policy on Proficiency Testing 7 / 32 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 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.

8 URP24-04 IAJapan Policy on Proficiency Testing 8 / 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.

9 URP24-04 IAJapan Policy on Proficiency Testing 9 / 32 (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.

10 URP24-04 IAJapan Policy on Proficiency Testing 10 / 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

11 URP24-04 IAJapan Policy on Proficiency Testing 11 / 32 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 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

12 URP24-04 IAJapan Policy on Proficiency Testing 12 / 32 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.

13 URP24-04 IAJapan Policy on Proficiency Testing 13 / 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.

14 URP24-04 IAJapan Policy on Proficiency Testing 14 / 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; E n ; - In principle, a participating calibration laboratory shall perform the

15 URP24-04 IAJapan Policy on Proficiency Testing 15 / 32 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

16 URP24-04 IAJapan Policy on Proficiency Testing 16 / 32 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 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 ), authorization of the final reports (4.8.1 of the same standard) and, as necessary, planning of the PT schemes ( of the same standard).

17 URP24-04 IAJapan Policy on Proficiency Testing 17 / 32 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 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.

18 URP24-04 IAJapan Policy on Proficiency Testing 18 / 32 Supplementary provisions (effective date) 1. This policy document applies after August 1, Supplementary provisions (Transitional measure) 1. Normative referenced in 3. in this policy document, JIS Q :1998 and JIS Q :1998 shall be applied only until JIS Q 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, Supplementary provision (effective date) 1. This policy document applies after May 1, Supplementary provision (effective date) 1. This policy document applies after September 2, Supplementary provision (effective date) 1. This policy document applies after October 1, 2014.

19 URP24-04 IAJapan Policy on Proficiency Testing 19 / 32 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).

20 URP24-04 IAJapan Policy on Proficiency Testing 20 / 32 Appendix B (Informative) Example of proficiency testing participation plan B.1 Example of proficiency testing participation plan for JCSS (record) Registration Accreditation Classes (Scope of Accreditation ) Length 5-Year Proficiency Testing Participation Plan Calibration method class Wavelength measuring instrument Length Measuring Measuring instrument type Wavelength of 633 nm He-Ne laser Gauge blocks Standard JCSS Calibration Branch, Company AAA Scheduled participation year 20X V 20X W 20X X 20X Y 20X Instrument Scale Mass Weight Weight Temperature Scale Contact type thermomete r Non-Automatic Electronic Weighing Instruments 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.) Person in Charge Prepared by Examined by Approved by Calibration Staff Technical Manager Z Technical Manager Date 20XV/mm/dd 20XV/mm/dd 20XV/mm/dd Seal or Sign Kukeko Kaki Ueo AI Ueo AI Seal Sea Seal

21 URP24-04 IAJapan Policy on Proficiency Testing 21 / 32 * 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 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.)

22 URP24-04 IAJapan Policy on Proficiency Testing 22 / 32 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 C NNNN name of laboratory/producer to be JCSS Calibration Branch, Company AAA assessed Accreditation Classes Temperature (contact type thermometer) (Scope of Accreditation)

23 URP24-04 IAJapan Policy on Proficiency Testing 23 / 32 No Relevant Alternative Means Requirements 1 ISO/IEC 17025: 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 of Appendix B, ISO/IEC E n 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.

24 URP24-04 IAJapan Policy on Proficiency Testing 24 / 32 C.2 An Example of the Confirmation on Alternative Means In Place of Proficiency Testing (JNLA) 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 S NNNN and name of laboratory/producer to JNLA laboratory, XXX Testing Center be assessed Accreditation Classes (Scope of Accreditation) Compressive strength testing of XXX Material, tensile testing of XXX Material, flexural properties testing of XXX Material

25 URP24-04 IAJapan Policy on Proficiency Testing 25 / 32 No Relevant Alternative Means Requirements 1 ISO/IEC 17025: 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 of Annex B, ISO/IEC 17043, and the criteria for the evaluation shall be agreed in advance between the laboratories. Program manager and laboratory representative have agreed on the above-mentioned alternative means. Date Laboratory representative Ueo Ai Program manager Tsuteto Tachi 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.

26 URP24-04 IAJapan Policy on Proficiency Testing 26 / 32 C.3 An Example of the Confirmation on Alternative Means In Place of Proficiency Testing (ASNITE) 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 Accreditation Classes (Scope of Accreditation) E NNNN Environmental Testing Laboratory, XX Analysis Center Environment (air): Titration (volumetric analysis)

27 URP24-04 IAJapan Policy on Proficiency Testing 27 / 32 No Relevant Alternative Means Requirements 1 ISO/IEC 17025: 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 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. Program manager and laboratory representative have agreed on the above-mentioned alternative means. Date Laboratory representative Program manager Ueo Ai 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.