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.

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
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. 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. 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
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
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
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
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. • 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
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. 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. 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. 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
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
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
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
Thank you for your kind attention.
Any questions?