ISO/DIS 9001:2015
What effects on the
nuclear sector?
N U CS I G E V E NT, BI RCHWOOD, 2 4 JU LY 2 0 1 4
G R A HA M WATSON
The objectives of the revision
1. Take account of the changes in technology and quality
management practices
2. Ensure the standard reflects changes in the increasingly
complex and dynamic organisational and business
environments
3. Facilitate effective implementation and conformity
assessment
4. Ensure the standard is adequate to provide confidence in
those meeting the standards requirements
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Overview of main changes
from ISO 9001:2008 (1)
• Common structure, terminology and
definitions
• Context of the organisation
• Risk-based thinking
• Leadership and engagement of top
management
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Annex SL
Introduction
1. Scope
2. Normative references
3. Terms and definitions
4. Context of the organisation
5. Leadership
6. Planning
7. Support
8. Operation
9. Performance evaluation
10. Improvement
ISO/IEC Directives, Part 1 —
Consolidated ISO Supplement —
Procedures specific to ISO
http://www.iso.org/iso/home/standards_development/resources-for-technicalwork/iso_iec_directives_and_iso_supplement.htm
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Overview of main changes
from ISO 9001:2008 (2)
Increased emphasis on
• Application of the process approach
• Regular review of inputs and other aspects
affecting the QMS
• Management of change
• Performance management and evaluation
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Overview of main changes
from ISO 9001:2008 (3)
Other new or significantly changed clauses
• People
• Organizational knowledge
• Control of externally provided products and
services
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Terminology
Includes 21 Annex SL terms and definitions
• audit, risk and interested party have been
slightly modified
• Revised definitions for product and service
(was product)
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Disposition of comments on
ISO/CD 9001
• 3,300 comments received on the Committee Draft from
national standards bodies and liaisons
• 5 groups dealt with those comments and produced a
working draft for the proposed DIS
• The working draft was sent to all WG24 members for
comment
• 1,300 comments were received and the majority were
dealt with in plenary in the Paris meeting.
• The work on the proposed DIS was subsequently
completed and endorsed by the WG members to go to
DIS.
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Main discussion points during the
disposition of CD comments (1)
• Annex SL
• Ballot results
• goods and services
• products and services
• exemptions/applicability
• continual improvement
ISO aims to develop standards by consensus – ballots are exceptional
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Main discussion points during the
disposition of CD comments (2)
• Context of the organization
• Relevant interested parties
• Documented information
• Risk-based thinking
• Knowledge
• External provision / Outsourcing
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Main discussion points during the
disposition of CD comments (3)
• Duplication and repetition
• planning
• change management
• documented information
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Main discussion points during the
disposition of CD comments (3)
• Generic content and dilution of
requirements
• Design and Development
• Calibration requirements
• Management representative
• Documented procedures
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Effects on the nuclear sector?
• Process-based management system. Not new, but
reinforced
• Risk-based thinking. Not something new, but should
introduce benefits to interactions with suppliers
• Consider both
• Context of the organization. Understand relevant "issues"
that affect ability to achieve intended results
• Needs and expectations of interested parties relevant to
the QMS.
in determining scope of QMS and planning for the QMS
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Effects on the nuclear sector?
• Customer focus - determine and address risks and
opportunities that can affect product and service
conformity.
• Documented information Vs documents and records
• Planning of changes
• Externally provided products and services - incorporates
purchasing, contracting and outsourcing
• Preventive action not included?
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Thank you for listening
Any questions?
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