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11

The status and issues of quality management system certification in Japan

Makoto Kubo

April 14, 2015

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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

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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

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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

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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

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Status of ISO 9001 Certification in JapanISO 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

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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

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

• 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

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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

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.

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

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.

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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

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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.)

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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.

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Thank you for your kind attention.

Any questions?