Accred Qual Assur (1997) 2 :111–114Q Springer-Verlag 1997 REVIEW PAPER

T. Ohtsubo The Japan Accreditation Board for

Conformity Assessment – Introduction to

the Japanese accreditation system

Abstract The background to theestablishment of the Japan Accre-ditation Board for Conformity As-sessment (JAB) is reviewed in re-lation to the latest global develop-ments in conformity assessment ac-tivities. JAB (known as the JapanAccreditation Board for QualitySystem Registration at the time ofits establishment) was establishedin 1993 as the accreditation bodyfor quality system registration, thefocal point for conformity assess-ment in the private sector in Japan.The extension of the area of accre-

ditation was made in June 1996,covering all conformity assessmentactivities including laboratory ac-creditation, which resulted in theamendment of the name of thebody to the current one. Variouselements of the laboratory accredi-tation program are introduced togive the overview of this new pro-gram.

Key words Japan 7 AccreditationLaboratories 7 Traceability 7Quality

Received: 2 October 1996Accepted: 5 December 1996

T. Ohtsubo (Y)The Japan Accreditation Board forConformity Assessment, Akasaka RoyalBuilding Annex, 6–18,Akasaka 7-Chome, Minato-ku, Tokyo, 107,JapanTel.: 81355610360; Fax: c81355610376

Introduction

Certification/registration [1] to ISO 9001/2 quality sys-tem standards is playing a rapidly expanding role in in-ternational trade. It is considered as a prerequisite forcompanies supplying their products and services inter-nationally. Also, certification/registration to ISO 14001environmental management system standard is now be-ginning to have an impact on suppliers.

Activities carried out by laboratories, inspectionbodies and products certification bodies [2] as well asmanagement system certification/registration bodiesare called “conformity assessment”. The primary objec-tive of conformity assessment is to provide users ofproducts and services with confidence in the result oftests, inspections, and certifications/registrations.

The accreditation of these bodies provides, bymeans of assessment and subsequent surveillance, anassurance that the market can rely on certificates issuedby the accredited conformity assessment bodies. Thereare, however, some concerns that the internationaltrade in products and services among countries have

been hindered by enforced repetitions of conformityassessment activities because purchasers and regulatorsin an importing country are not confident of the com-petence of the foreign conformity assessment bodies inexporting countries. Repetitions of conformity assess-ment activities will be minimized if the mutual recogni-tion agreement among conformity assessment bodiesand/or accreditation bodies is concluded on the basis ofthe demonstrated equivalence of criteria, the interpre-tation of criteria, and procedures of conformity assess-ment, which will be confirmed through peer evaluationprocesses among the conformity assessment bodiesand/or accreditation bodies involved.

In this paper, the overview of the Japanese accredi-tation system covering all conformity assessment areaswill be introduced, with particular emphasis on labora-tory accreditation.

Global overview of conformity assessment activities

The agreement on the technical barrier to trade (TBT)of the World Trade Organization (WTO), which has

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been signed by many countries in the world and is ef-fective from January 1996, requests signatories, in thestandards and conformance area, to use internationalstandards where possible and to rely on competent con-formity assessment bodies which comply with interna-tionally accepted documents [3].

Recommendation of JISC

The Japanese principal policy of conformity assessmentin the private sector has been established by the JapanIndustrial Standard Committee (JISC) as a recommen-dation, “Quality Systems Assessment and RegistrationScheme in Japan”, which was submitted to the Ministerof International Trade and Industry and the Minister ofTransport in June 1992. The recommendation was thatan accreditation body should be established initially tocover the quality system registration program as a pri-vate organization by the initiative of the private sector,that the accreditation body should comply completelywith internationally accepted documents, and that theaccreditation body should, in the future, be expandedto cover all conformity assessment areas which the pri-vate sector considers necessary as a sole accreditationorganization rather than establishing multiple accredi-tation bodies.

Establishment of JAB

The Federation of Economic Organizations (Keidan-ren) agreed to the policy described in the recommenda-tion mentioned above, and decided to support finan-cially the establishment of the Japanese private sectoraccreditation body. The Japan Accreditation Board forQuality System Registration (JAB) was thus estab-lished in November 1993 as a private foundation in ac-cordance with Article 34 of the Civil Code Act, and wassupported by the fund contributed by many industrialand economic federations. The establishment of JABwas then recognized by the Minister of InternationalTrade and Industry (MITI) and the Minister of Trans-port (MOT) in November 1993. JAB commenced theaccreditation of quality system registration bodies andrelated functions in December 1993.

Amendment of the terms of reference

JISC published a report in May 1995 recommendingthat JAB should prepare for new accreditation func-tions such as accreditation of laboratories and certifica-tion bodies for products and personnel. In May 1996,JISC published another report suggesting the basic pol-icy in establishing the environmental management sys- Fig. 1 Organizational structure of JAB

tem registration in Japan. In response to these reports,JAB established committees for the preparation of cri-teria and procedures for these new accreditation func-tions. In June 1996, the JAB’s Board of Directors ap-proved the amendment of the terms of reference, ex-panding its accreditation function to cover all conformi-ty assessment areas including management system reg-istration, laboratories, inspection bodies and productand personnel certification bodies based on the signifi-cant progress in the preparations for the new functions.As the result of this amendment, the name of the bodywas also changed to “The Japan Accreditation Boardfor Conformity Assessment” with the acronym JAB(which thus remained as it was). The amendment of theterms of reference has been recognized by the Minis-ters of International Trade and Industry and Transport.The organizational structure of JAB is shown inFig. 1.

Current status of JAB

Quality system accreditation program

JAB started the accreditation of quality system regis-tration bodies and related functions in December 1993,using draft ISO/IEC Guide 61, “General requirementsfor assessment and accreditation of certification/regis-tration bodies”, and draft ISO/IEC Guide 62, “Generalrequirements for bodies operating assessment and cer-tification/registration of quality systems”, as normativedocuments.

As of September 1996, JAB has granted accredita-tion to 16 quality system (QS) registration bodies, andthree bodies are under process of assessment. These in-clude foreign bodies whose head offices are locatedabroad. JAB has granted accreditation to seven QS au-ditor training bodies, and two bodies are under processof assessment. Approximately 700 h auditors, including405 lead auditors and 279 auditors, have been evalu-ated and registered. Approximately 1800 suppliers havebeen registered by JAB-accredited registration bodies.

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JAB has started a new accreditation program for QSauditor certification bodies and will terminate its audi-tor registration program upon granting the first accredi-tation to an auditor certification body in view of thespecification [4] of the newly published ISO/IEC Guide61. JAB is currently preparing for the revision of crite-ria and procedures documents to align them with thenewly published ISO/IEC Guides 61 and 62.

JAB is actively cooperating in the international ar-ena towards the realization of mutual recognitionamong accreditation bodies as a full member of IAF(the International Accreditation Forum), which is theinternational organization of accreditation bodies formanagement system and products certification, andPAC (Pacific Accreditation Cooperation), which is theregional organization of accreditation bodies for man-agement system and products certification in Asia andthe Pacific region.

Environmental management system accreditationprogram

In June 1996, JAB started its accreditation program forthe environmental management system (EMS) registra-tion. Criteria and procedures for the accreditation ofEMS registration bodies have not been published as anISO/IEC Guide. JAB has therefore prepared criteriaand procedures documents based on ISO/IEC Guides61 and 62 with minimum amendments such as replace-ment of the words “quality system” with the words “en-vironmental management system”.

As of September 1996, JAB has received applica-tions for accreditation from eight EMS registrationbodies and is currently assessing these applications.JAB has also started its accreditation programs forEMS auditor training bodies and EMS auditor certifi-cation bodies. It has received applications for accredita-tion from five EMS auditor training bodies but has notso far received any application from an EMS auditorcertification body.

Accreditation program for personnel qualification

JAB has prepared criteria and procedures, based onEN 45013 (the European standard for a personnel cer-tification body) and ISO/IEC Guides 61 and 62, for theaccreditation of personnel certification bodies engagedin the qualification of welding technicians and non-de-structive testing technicians, because these documentsare not yet available as ISO/IEC Guides. JAB is ex-pected to start receipt of applications for this new ac-creditation program in October, 1996.

Accreditation program for product certification

JAB is prepared to start preparatory work upon receiptof a formal request for this accreditation program fromany interested party.

Laboratory accreditation program

There is no laboratory accreditation program for test-ing laboratories yet in place in Japan, although JCSS(Japan Calibration Service System), operated by theMITI/Office of Weights and Measures, started a similarrecognition service a few years ago with a very limitedscope, i.e. calibration laboratories.

JAB has policies regarding laboratory accreditation,i.e. that JAB is primarily responsible for the accredita-tion of testing laboratories in the private sector andthat scopes of accreditation for which an accreditationservice will be provided should be chosen according tothe needs of the private sector. In establishing the newlaboratory accreditation program, in view of the lack ofexperience and knowledge in this field within Japan,JAB has asked for technical support from NATA (theNational Association of Testing Authorities in Austra-lia) and from NVLAP (the National Voluntary Labora-tory Accreditation Program in the USA). Two JAB of-ficers were subsequently trained as attachment traineesat NATA and NVLAP, respectively.

Criteria and procedures

JAB has prepared its criteria document, RL 100, andprocedures document, RL 300, for the accreditation oflaboratories based on ISO/IEC Guides 25 and 58, re-spectively. Supplementary guidance documents havealso been prepared for the specific technical areas forwhich scopes of accreditation will be granted.

General procedures for a laboratory seeking accre-ditation are as follows:– Letter of intent by the laboratory– Preliminary assessment of the laboratory to design

the assessment team appointed by JAB– Formal application for accreditation with supporting

documents by the laboratory– Assessment of documents by JAB– Participation in the proficiency test by the labora-

tory– On-site assessment of laboratories by JAB– Decision for granting accreditation by JAB– Granting accreditation by JAB– Surveillance by JAB– Re-assessment by JAB.

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Auditors

Several quality system auditors (who comply with therequirements of ISO 10011-2) and technical experts(who have sufficient technical knowledge on the specif-ic area for which laboratories are seeking accreditation)have been trained for the general criteria and proce-dures of the laboratory accreditation.

Scopes of accreditation

During the initial stage, JAB’s accreditation service willbe limited to the following three scopes:– Electro-magnetic compatibility (EMC) tests using

CISPR 16/22 as testing standards– High voltage tests using IEC 60 as a testing stand-

ard– Certified reference material producers using ISO/

IEC Guide 25, ISO Guide 34 and ISO 9002 as re-quirement documents.Scopes of accreditation will be expanded in the fu-

ture in accordance with requests from users of test re-ports and laboratories.

Traceability to national measurement standard

Laboratories seeking JAB’s accreditation will be re-quested to establish and maintain traceability to the na-tional measurement standards through the JCSS ar-rangement. Where traceability to the national measure-ment standard is not available through the current ar-rangements of JCSS, traceability to the internationalmeasurement standard will be requested.

Proficiency tests

Laboratories seeking JAB’s accreditation will be re-quested to participate in the proficiency test, which willbe jointly organized by JAB and the National Instituteof Technology and Evaluation (NITE). The result ofthe proficiency test will be duly considered during doc-uments assessment and on-site assessment of the appli-cant.

International cooperation

From the period when JAB carried out preparatorywork for launching the laboratory accreditation pro-gram, it also participated in the international activitiesof ILAC and APLAC. JAB has participated in thenewly reformed ILAC (International Laboratory Ac-creditation Cooperation)1 as a full member, and hasalso signed the Memorandum of Understanding as afull member of APLAC (Asia Pacific Laboratory Ac-creditation Cooperation). JAB is prepared to cooper-ate with the members of these international organiza-tions and to contribute to the various fields of activitiesof these organizations.

Conclusions

JAB was established in November 1993 as a privatenon-profit-making foundation to operate the accredita-tion program for quality system registration bodies inJapan. It has accredited 16 quality system registrationbodies and 7 auditor training bodies. About 2000 sup-pliers have been registered in accordance with ISO9001/2 by the JAB-accredited registration bodies. Somehundreds more suppliers have been registered by regis-tration bodies which are in the process of accreditationassessment by JAB.

In June 1996, JAB extended its terms of reference toprovide accreditation covering all conformity assess-ment areas including laboratory accreditation. JAB isnow launching its new laboratory accreditation pro-gram for a very limited number of areas such as EMC,high voltage measurements and CRM producers, andexpects to expand the scope of accreditation accordingto the needs of laboratories and users of test results.JAB is looking forward to concluding, on the basis ofthe established confidence in the program, the MutualRecognition Agreement with the former partners with-in APLAC, EAL and ILAC.

1 ILAC had been a broad forum of laboratories, users of test re-sults and laboratory accreditation bodies, but was re-organized inSeptember 1996 as an international organization of laboratory ac-creditation bodies

References

1. ISO/IEC Guide 62 (1996) General re-quirements for bodies operating as-sessment and certification/registrationof quality6 system, Clause 1.1 Scope

2. ISO/IEC Guide 65 (1996) General re-quirements for bodies operating prod-uct certification system, Clause 1.1Scope

3. ISO/IEC Guides, for example, ISO/IEC Guide 25, 58, 61, 62 and 65

4. ISO/IEC Guide 62 (1996) General re-quirements for bodies operating as-sessment and certification/registrationof quality system, Clause 2.1.2