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ISO/TC 176/SC 2/WG23 N062

ISO 9001:2015 Revision Overview

August 2013

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Introduction 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 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

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Outline A change to ISO 9001 is coming

Why this change is taking place (rationale for the changes)

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 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

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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”)*� 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

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ISO 9001A change is coming

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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

Background Information

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What is being considered? International experts nominated by ISO

member bodies looked at a number of items to help guide revision activities:

– 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

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ISO 9001:2015 RevisionScope

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Design Specification Strategic Intent 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

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Design Specification Change Criteria Increase confidence in an organization's ability

to provide conforming goods and/or services

Enhance an organization's ability to satisfy its customers

Enhance customer confidence in quality management systems based on ISO 9001

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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

Reasons For The Changes

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Decrease the emphasis on Documentation

Increase the emphasis on Achieving Value for the Organization and its customers

Increase emphasis on Risk Management to achieve objectives

Reasons For The Changes

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ISO 9001:2015 RevisionWhat users should know

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What is changing?New concepts are being considered

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 thecontents 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

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High Level Structure (HLS)1. Scope 2. Normative references 3. Terms and definitions 4. 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

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Applying Annex SL to ISO 9001:2015 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

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Annex SLThe high level structure and common

text without ISO 9001:2015 management specific text is public information

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 (9001 WW Survey Result)

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ISO 9001 - New Concept ImportanceHow 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

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

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

(

ISO InputFor Future

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Weak Areas of Implementation

Emphasis on continual improvement

Constant focus on preventive actions

Root cause analysis and weak preventive actions

Use of process approach

Handling of Customer Complaints

Guidance Documents?White Papers?

VoDs?

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.

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What product support can I expect?Transition plan (timeframe for certification)

Supporting guidance documents

Correlation annex (map of the changes)

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

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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

Users Should Know

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ISO 9001:2015 RevisionTimeline for the changes

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ISO 9001:2015 Timeline

+ Transition period for certification

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Impact on other standards that are part of the family

�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

Other Important Information

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ISO 9001:2015 RevisionWhat organizations can do

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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!

I need to ensure my Organization . . .

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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

Organizational Opportunities

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ISO 9001:2015 RevisionProduct 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

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Supporting Guidance DocumentsIntroduction 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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