ISO/DIS 9001:2015 What effects on the nuclear sector?

N U CS I G E V E NT, BI RCHWOOD, 2 4 JULY 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 2 24 July 2014 ISO/DIS 9001 PRESENTATION TO NUCSIG

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 24 July 2014 ISO/DIS 9001 PRESENTATION TO NUCSIG 3

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-technical work/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 24 July 2014 ISO/DIS 9001 PRESENTATION TO NUCSIG 5

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 24 July 2014 ISO/DIS 9001 PRESENTATION TO NUCSIG 6

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) 24 July 2014 ISO/DIS 9001 PRESENTATION TO NUCSIG 7

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 24 July 2014 ISO/DIS 9001 PRESENTATION TO NUCSIG 9

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 10 24 July 2014 ISO/DIS 9001 PRESENTATION TO NUCSIG

Main discussion points during the disposition of CD comments (3) • Duplication and repetition • planning • change management • documented information 24 July 2014 ISO/DIS 9001 PRESENTATION TO NUCSIG 11

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 24 July 2014 ISO/DIS 9001 PRESENTATION TO NUCSIG 12

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 13 24 July 2014 ISO/DIS 9001 PRESENTATION TO NUCSIG

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? 24 July 2014 ISO/DIS 9001 PRESENTATION TO NUCSIG 14

Thank you for listening Any questions?

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