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ISO 9000 series

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BS 5750 (1979)

 United Kingdom in 1979: BS 5750 -


Quality Management Systems.
 Developed to permit a company to
document its commitment to quality and
the standard of its quality systems.

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ISO 9000:1987 series
 International Organisation for Standards
(ISO) adopted a series of quality standards,
ISO 9000:1987
 Based on BS 5750
 Influenced by the US Department of Defence
Military Standards (MIL specs).
 Initial version was focused on quality control
using retroactive checking and corrective
actions.
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ISO 9000:1994 series
 ISO 9000 revised in 1994
 Greater emphasis on quality assurance
via preventive actions.
 Required evidence of compliance with
documented procedures
 Tended to create a significant volume of
associated procedure
("do it as you document it") manuals
and bureaucracy.
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QS-9000

 Ford, Chrysler, General Motors and other


automotive/truck manufacturers identified
deficiencies in ISO9000:1994
 undertook a re-interpretation and
extension to develop QS-9000
 additionally addressed continuous
improvement, manufacturing capability
and production part approval processes.

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ISO9000:2000 series

 moved towards
process performance metrics
 reduced the need for
documented procedures
where clear evidence exists
that the process is working well.

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ISO9000:2000 series
 standards provide criteria for companies to
 "certify" their quality management
recertification is required every three years
 achieve "registration" by third-party auditor.
 the system
verifies practice and processes
provides objective 3rd party validation
enables benchmarking.

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ISO 9000:2000
Eight ‘Clauses’
1. Customer focus
2. Leadership
3. Involvement of people
4. Process approach
5. System approach to management
6. Continual improvement
7. Factual approach to decision making
8. Mutually beneficial supplier relationships

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ISO 9000:2000 series
Four primary
‘Quality Management Standards’

1. ISO 9000: QMS Fundamentals and


Vocabulary

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2. ISO 9001: QMS – Requirements

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3. ISO 9004 - Guidance for Performance
Improvement

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4. ISO 19011: Guidelines on Quality and
Environmental Auditing

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ISO 9000:2000 structure

Four major sections

1. Management Responsibility
2. Resource Management
3. Product Realisation
4. Measurement, Analysis and Improvement

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ISO 9000 structure I
Divided into 21 elements
Management Responsibility
1. management commitment
2. customer focus
3. quality policy
4. planning
5. administration
6. management review

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Resource Management

7. provision of resources
8. human resources
9. facilities
10. work environment

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Product Realisation
11. planning of realisation processes
12. customer-related processes
13. design and/or development
14. purchasing
15. production and service operations
16. control of measuring and monitoring
devices

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Measurement, Analysis and Improvement

17. planning
18. measurement and monitoring
19. control of nonconformity
20. analysis of data
21. improvement

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QMS costs

 costs of certification may be considerable.


Evans and Lindsay [page 137] suggest
• registration audit may cost US$10-40K
• training and documentation of order of US$100K.
recording of the activities of the company
can save money: the data used to
• inform individual changes
• underpin continuous improvement programs
• invaluable as evidence in the event of litigation
November 14, 2009 ISO
Consequent upon ISO 9000...

 DuPont
o increased on-time deliveries from 70-90%
o decreased cycle times from 15 to 1.5 days
o increased first-pass yields from 72 to 90%
o reduced number of test procedures by 1/3.

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 Toronto Plastics (Canada)
o reduced defects/1000 from 150 to 15 in 1
year
 Delcor Homes (Michigan builder)
o reduced correctable defect rates
from 27.4 to 1.7 in just two years.

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Other Quality standards
• ISO 10006 : project management
• ISO 10007 : configuration management
• ISO 10012 : measurement systems
• ISO 10013 : quality documentation
• ISO/TR 10014 : managing economics
of quality

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Other relevant standards II ...

• ISO 10015 : training


• ISO 17799 : security
• ISO 19011 : auditing
• ISO / TS 16949 : automotive suppliers
• ISO 17021 part one: conformity
assessment ... for bodies providing
audit/certification of management systems

November 14, 2009 ISO


Other relevant standards III ...

• BS 8300:2001 Design of buildings and


their approaches to meet the needs of
disabled people
• BS 8887-1:2006 Design for
manufacture, assembly, disassembly
and end-of-life processing (MADE).
General concepts,
process and requirements
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BS 7000 Design Management Systems.

1. Guide to managing innovation


2. Guide to managing the design of
manufactured products
3. Guide to managing service design
4. Guide to managing design in construction
5. Guide to managing obsolescence
6. Managing inclusive design. Guide
10. Glossary of terms used in design
management
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Product design for SMEs
• BS 7373-1:2001 Guide to the
preparation of specifications.
• BS 7373-2:2001 Product specifications.
Guide to identifying criteria for a
product specification and to
declaring product conformity
• BS 7373-3:2005 Product specifications.
Guide to identifying criteria for
specifying a service offering
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