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The Status and Issues of Quality Management System Certification in Japan

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Promote the use of quality management certification by the purchasers, supply chain and industrial groups, together with to improve the credibility of certification in Japan presented by Makoto Kubo - Japan Accreditation Board.

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The Status and Issues of Quality Management System Certification in Japan

  1. 1. Copyright 2015 QuEST Forum. All Rights Reserved. 1 1 The status and issues of quality management system certification in Japan Makoto Kubo April 14, 2015
  2. 2. 2 Contents • Japan Accreditation Board • Status of QMS certification in Japan • Issues of QMS certification in Japan • Benefits to utilize QMS certification • Solutions to the Issues and Concerns • Conclusion 2
  3. 3. 33 History of JAB • Established on November 1, 1993  the first accreditation body (AB) established in Japan as a private non-profit organization  established in accordance with the recommendation presented by the Japanese Industrial Standards Committee (JISC) and  supported by 35 industrial organizations under the auspices of the Japan Federation of Economic Organizations (KEIDANREN:Japan Business Federation) • the only AB in Japan carrying out almost all accreditation programs related to IAF/ILAC • A member of Japan Accreditation Council cooperating with other Japanese ABs, JASC, IA-Japan, VLAC, JIPDEC
  4. 4. 44 Objectives of JAB • to establish and develop conformity assessment schemes in Japan, and • to achieve mutual recognition arrangements with accreditation bodies abroad, • through which to support the sound development of the Japanese industry and fair economic activities and contribute to building a reassuring and safe social foundation
  5. 5. 5 Status of ISO 9001 Certification in Japan 0 10,000 20,000 30,000 40,000 50,000 60,000 70,000 80,000 90,000 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 ISO 9001 出典:2013 ISO Survey Ratio to the world total in 2013 = 4.1% Ratio to the world total in 2006 = 9.0% Based on ISO Survey 2013
  6. 6. 6 Status of ISO 9001 Certification in Japan ISO 9001 出典:2013 ISO Survey 0 2000 4000 6000 8000 10000 12000 14000 16000 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 14 17 18 19 28 29 34 28 Construction 17 Basic metals and fabricted Metal Poduct 19 Electrical and optical equip. 29 Whole sales and retail trades 34 Engineering services 14 Rubber and plastic product 18 Machinery and equipmants The decrease occurred in mainly construction field after the year 2006. Based on JAB Survey
  7. 7. 7 Status of Sector QMS Certification in Japan TL 9000 Ratio to the world total =1.7% Ratio to the world total = 3.2% Aerospace QMS
  8. 8. 8 Medical device QMS (ISO 13485) Automobile QMS (ISO/TS 16949) Ratio to the world total =3.3% Ratio to the world total = 2.4% Based on ISO Survey 2013 Status of Sector QMS Certification in Japan
  9. 9. • The number of ISO 9001 certificates has been decreasing after the year of 2006. < What is its reason? > - No strong user of the results of ISO 9001 certification as it was until the year 2006 - Not achieve intended outcomes - Not contribute to the business - Lack of confidence caused by the malfunctions of certified organizations - Separation from business process etc • The number of TL 9000 certificates is still very small and doesn’t show growing. Issues of QMS Certification in Japan
  10. 10. 10 Main Changes of ISO 9001 Revision 1) The adoption of the HLS (high level structure) as set out in Annex SL of ISO Directives Part 1. 2) An explicit requirement for risk-based thinking to support and improve the understanding and application of the process approach. 3) Fewer prescribed requirements. 4) Less emphasis on documents. 5) Improved applicability for services. 6) A requirement to define the boundaries of the QMS. 7) Increased emphasis on organizational context. 8) Increased leadership requirements. 9) Greater emphasis on achieving desired outcomes to improve customer satisfaction. Based on DIS 9001, IAF ID9
  11. 11. Expectations & Concerns to the Revision - Personal View - Expectations: – More strategic QMS operation along the intension of top management – Establishment of QMS more integrated to business processes – Improved probability to achieve QMS performance objectives – Improvement of technologies related to the quality of products and services – Wider applications to service business More beneficial and valuable for both organizations and stakeholders Concerns: – QMS operated based on business strategy – Prescriptions focused on functions more than methods – Prescription in more general expression to widen applicability Auditors need more competence in terms of industrial knowledge and effectiveness audit. Some guidance in each sector may be helpful for auditors.
  12. 12. Benefits of the Use of QMS Certification Benefits for certified org. : – to get confidence of customers – to maintain and expand business trade – to reduce the cost for receiving audits of customers – to respond to the troubles with customers smoothly and quickly Benefits for purchasers : – to make the selection of suppliers more easy/efficient – to reduce administrative cost of suppliers – to reduce internal cost caused by supplied products and services – to quickly respond to the troubles of their own products and services – to improve the competence of their own products and services
  13. 13. Benefits of the Use of QMS Certification Benefits for supply chain/industrial group : – to reduce risks and administrative cost through supply chain – to get social confidence to industrial group – to improve the competence of the products and services provided to consumers – to improve the international competence of the industrial group – to enhance the development of new products and services in the new business field Especially in the telecommunication field  Technology innovations occurred so rapidly.  It is a way to create product certification scheme in order to get the confidence to product and service quality.  But it often takes time to create new certification schemes. It is more useful and beneficial to use TL 9000 certification in this business field.
  14. 14. 14 Comparison of QMS sector schemes Schemes TL 9000 AS-QMS MD-QMS Owner QuEST Forum International Aerospace Quality Group (IAQG) none Audit/ Assessment criteria etc, TL 9000 RH&MH Alert AQMS (910/9110/9120) 9101、9104 ISO 13485 IAF MD9 Oversight Validation audit to certified org. by AB with QuEST Forum Oversight by industrial members none Data base MRS Statistical QMS performance data for benchmarking OASIS Data including audit reports, client feedback etc. Certification status on the website of each AB and CB Features Focused on improvement by benchmarking certified org. Focused on improvement through supply chain by publicly disclosing certification info. Focused on the utilization by regulatory
  15. 15. 15 Solutions to the Issues and Concerns To improve the credibility of certification – Sector specific requirement and guidance based on the stakeholders’ needs – Competence of auditors and assessors – Disclosure of certification info. – Benchmarking certified organizations (sharing good practices among certified org.) Especially some guidance to the revised ISO 9001 from sectors will be helpful To promote the utilization of the certification results – Propaganda of the benefits to use the results of certification in the trade ( government officers, purchasers in down stream of supply chain like service providers, big retailers, manufactures of consumer products, etc.)
  16. 16. 16 Conclusion • It is very important to promote the use of QMS certification by the purchasers, supply chain and industrial groups, together with to improve the credibility of certification. • In order to spread TL 9000 certification in Japan JAB will support QuEST Forum Japan Hub and contribute to their promotion activities to service providers.
  17. 17. 17 Thank you for your kind attention. Any questions?

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