ISO 9001 2015 Revision Overview

ISO 9001:2015 Revision Overview August 2013 ISO/TC 176/SC 2/WG23 N062 1

Introduction

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 This presentation has been developed by the Communications and Product Support group of ISO/TC176/SC2, the ISO subcommittee responsible for the ISO 9001 and ISO 9004 standards, among others  It provides basic information about the revision to ISO 9001, free of charge, to interested parties, and will be updated periodically as the revision progresses

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Disclaimer

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 Any claims or statements made by the presenter based on this presentation represent their own opinions and/or interpretation, and are not formally endorsed by ISO or its subcommittee TC176/SC2, responsible for the ISO 9001 revision  This presentation includes information related to the status of the revision process as of JULY 2013  Further changes are likely as the revision process progresses, so you should NOT make changes to your management system at this stage 3 Date:

Outline  A change to ISO 9001 is coming  Why this change is taking place (rationale for the changes)

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 What users of ISO 9001 should know  Timeline – target is to publish in September 2015 (ISO 9001:2015)  Organizational Opportunities  Product Support  Expect further updates as this process evolves

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ISO Facts

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 ISO = International Organization for Standardization ̶

Based in Switzerland ̶

Made up of over 100 National Standards Bodies (“NSB’s”) ̶

Almost 20,000 standards in the ISO portfolio ̶

All standards are based on INTERNATIONAL CONSENSUS

 ISO standards are usually developed by its Technical Committees (“TC’s”) and Sub-committees (“SC’s”) ̶

ISO/TC176/SC2 (Quality Systems) is responsible for ISO 9001

 ISO 9001:2015 is being developed by a specific SC2 Working Group (“WG24”) ̶

WG24 is composed of international experts nominated by their NSB or from formal liaison member to ISO (typically industry associations) ̶

WG23 is responsible for Communications and Product Support 5 Date:

ISO 9001:2015 - Development Process  Agreement on the need for revision* ̶

“Systematic Review” and “New Work Item”

 Agreement on the scope and objectives (“Design Specification”)*  Working Drafts (“WD’s”) ̶ ̶

Preliminary drafting by international experts nominated by ISO member bodies WD’s are very rough documents - not normally made widely available

 Committee Draft (“CD”)* ̶

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̶

Once preliminary WDs have reached an acceptable level of maturity, they are “uprated” to CD that is formally circulated to ISO Member bodies NSB’s are expected to convene national interested parties to comment on CD

 Draft International Standard (“DIS”)* ̶

Published after approval of CD by formal ballot, and incorporation of pertinent comments

 Final draft international standard (“FDIS”)* ̶

Published after formal approval of the DIS, and incorporation of pertinent comments

 International Standard ̶ ̶

Published after approval of the FDIS Subject to “systematic review” every 5 years * = Balloted by ISO member bodies 6 Date:

ISO 9001 ISO/TC 176/SC 2/WG23 N062

A change is coming

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Background Information  ISO Standards are reviewed every five years to ensure they stay up-to-date – revisions are part of the ISO process and are to be expected  A formal global review of ISO 9001 was completed in 2012 among ISO member bodies. This resulted in a decision to revise the standard  As with all ISO standards, this will be a consensus process ̶ All ISO’s National Member Bodies (NMBs) and official liaison members nominate experts to participate in the drafting process ̶ Drafts of ISO 9001 will circulated for comments and balloted at appropriate stages by NMBs  Work on the revision has already begun 8 Date:

What is being considered?  International experts nominated by ISO member bodies looked at a number of items to help guide revision activities:

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– an extensive web-based user survey – new quality concepts and ideas for inclusion in ISO 9001 – revised quality management principles – formal interpretations of ISO 9001:2008 – support and guidance notes 9 Date:

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ISO 9001:2015 Revision Scope

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Design Specification Strategic Intent

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 Take account of changes in quality management systems practices and technology since its last major revision (2000) and to provide a stable core set of requirements for the next 10 years or more  Ensure that requirements in this standard reflect the changes in the increasingly complex, demanding, and dynamic environments in which organizations operate  Ensure that requirements are stated to facilitate effective implementation by organizations and effective conformity assessment, as applicable 11 Date:

Design Specification Change Criteria  Increase confidence in an organization's ability to provide conforming goods and/or services

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 Enhance an organization's ability to satisfy its customers  Enhance customer confidence in quality management systems based on ISO 9001

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Reasons For The Changes

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 In the last 25 years, many other Management Systems Standards have come into use world wide  Organizations that use multiple Management System Standards are increasingly demanding a common format and language that is aligned between those standards

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Reasons For The Changes  Decrease the emphasis on Documentation

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 Increase the emphasis on Achieving Value for the Organization and its customers  Increase emphasis on Risk Management to achieve objectives

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ISO 9001:2015 Revision What users should know

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What is changing?  New concepts are being considered

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 The customer remains the primary focus  A new common ISO format has been developed for use across all Management System Standards

Please note that since the contents are under development, there may be further changes

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High Level Structure - Common Text Annex SL  Mandated by ISO’s Technical Management Board (TMB)  High level structure, identical core text and common terms and core definitions for use in all Management System Standards  Purpose - Enhance the consistency and alignment of different management system standards  Organizations who implement a single system addressing multiple standards (e.g. QMS, EMS, ISMS etc) will see the most potential benefit 17 Date:

High Level Structure (HLS)

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1.

2.

3.

4.

Scope Normative references Terms and definitions Context of the organization • Understanding the organization and its context • Needs and requirements • Scope • Management System 5. Leadership • General • Management commitment • Policy • Roles, responsibility and authority 6. Planning • Actions to address risks & opportunities • Objectives and plans to achieve them

7. Support • Resources • Competence • Awareness • Communication • Documented information 8. Operation • Operational planning and control 9. Performance evaluation • Monitoring, measurement, analysis & evaluation • Internal audit • Management review 10. Improvement • Non conformity and corrective action • Continual Improvement 18 Date:

Applying Annex SL to ISO 9001:2015

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 The objective is to develop the revised ISO 9001 standard using the new structure as the foundation  TC 176/SC2 plays an active role in ISO’s Joint Technical Coordination Group that is responsible for the development of Annex SL and any difficulties in applying Annex SL will be referred back to this group and to ISO/TMB 19 Date:

Annex SL  The high level structure and common text without ISO 9001:2015 management specific text is public information

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 It can be found at www.iso.org/directives

Please note that Annex SL on its own should not be used to make changes to your management system

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Future Relevance of ISO 9001:2008

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(9001 WW Survey Result)

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ISO 9001 - New Concept Importance

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How important is it to incorporate the following concepts into ISO 9001?

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World-wide Survey - Key User Inputs  ISO 9001, as it is, must change to continue be relevant

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 Integrate with other MSS (EMS etc.)  Provide one integral approach to the management of the organization for Leadership commitment & understanding, strategic planning, management buy-in

ISO Input For Future

(

 Need to work with ISO/CASCO and IAF to ensure efficiency/effectiveness of audits and address problems in certification audits  Include tools and risk management 23 Date:

Weak Areas of Implementation

ISO 9001—Its relevance and impact in Asian Developing Economies: Project initiated by UNIDO, funded by Norad and supported with technical inputs by ISO and the IAF.

 Emphasis on continual improvement  Constant focus on preventive actions Root cause analysis and weak actions

preventive

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 Use of process approach  Handling of Customer Complaints

Guidance Documents?

White Papers?

VoDs? 24 Date:

What product support can I expect?  Transition plan (timeframe for certification)  Supporting guidance documents  Correlation annex (map of the changes)

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 FAQs (Frequently asked Questions)  ISO Quality Systems website updates  Other ISO 9001 related products  Summary of changes between ISO 9000, ISO 9001 and ISO 9004 25 Date:

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Users Should Know  The Committee Draft (CD) is the first opportunity for the draft standard to be scrutinized by a wider audience, beyond the nominated experts in WG24  National Member Bodies of ISO are required to VOTE on the CD, and may provide comments  Comments received will be addressed during the WG24 meeting in November 2013  Work is currently on schedule according to the Project Plan, with a planned publication date of September 2015 26 Date:

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ISO 9001:2015 Revision Timeline for the changes

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ISO 9001:2015 Timeline

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+ Transition period for certification

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Other Important Information  Impact on other standards that are part of the family

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̶ Expect changes to industry-specific standards to follow as these are updated over time ̶ Expect changes to supporting documents as these are modified in the future

 Expect further news updates as this process evolves 29 Date:

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ISO 9001:2015 Revision What organizations can do

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I need to ensure my Organization . . .

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 Knows what is going on and is ready to implement the new requirements  Takes full advantage of the revision of ISO 9001 to improve business performance Remember, don’t make any changes yet!

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Organizational Opportunities

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 Integrate their activities within the scope of multiple Management System Standards  Decrease the emphasis on documentation when this is not mandated or does not add value

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ISO 9001:2015 Revision Product Support

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ISO 9001:2015 - Product Support  Formal Transition Plan for certified organizations  Supporting guidance documents will be modified as needed (see www.iso.org)  Correlation Annex – showing the changes from ISO 9001:2008 to ISO 9001:2015  Website with FAQs  Other products will be developed as needed to support the new requirements  Relationship between ISO 9001 and ISO 9004 will be updated and clarified 34 Date:

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Supporting Guidance Documents Introduction and Support Package: ̶ Guidance on the Documentation Requirements of ISO 9001:2015 ̶ Guidance on some of the new, changed and frequently used words found in the ISO 9000 family of standards ̶ Guidance on the Concept and Use of the Process Approach for management systems ̶ Guidance on Outsourced Processes ̶ Implementation Guidance for organizations currently using ISO 9001:2008 ̶ and more…

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Stay Tuned!

Additional updates and information will be made available as the change process proceeds

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