1. ISO 9001:2015 Revision Overview
August 2013

2. 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 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
Emphasize that the information presented today is based on current work of WG24 and should not be used to make any changes to an organization’s quality management system since it could change.

3. 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
Emphasize that the information presented today is based on current work of WG24 and should not be used to make any changes to an organization’s quality management system since it could change.

4. 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

5. 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

6. 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

7. ISO 9001
A change is coming

8. 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 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

9. 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

10. ISO 9001:2015 Revision
Scope

11. 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
The information related to the strategic intent of the design specification is a verbatim of actual text in the design specification.

12. 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
This critieria is published in the Design Specification.
The focus of any changes made in the ISO 9001:2015 revision should meet the following intent.

13. Reasons For The Changes
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 .

14. Reasons For The Changes
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

15. ISO 9001:2015 Revision
What users should know

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

17. 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
Emphasize that the structure has been mandated by the TMB and that the belief is that this will enhance consistency.
This information is based on published information related to Annex SL and not directly the result of any particular published study or survey.

18. 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
Focus on that the high level structure and that the new structure should not cause an organization to renumber existing documents. However, it is realized that this might have a significant impact on software.
Common stamp format and quantity to support businesses
New stamps across the enterprise (pilot one site in 2011, complete all sites/programs in 2012)
Single source vendor contract
Approvals from applicable functions/ business units of common solutions
IT system (eSMS) for single source ordering/delivery system
Common process writings (3-BPIs, 1-PRO, sub-tier writings)
Training developed for AS9100C Auditors
QMS Teams will work with programs and sites to help them prepare
Internal Audit schedules developed 18

19. Applying Annex SL to ISO 9001:2015
The objective is to develop the revised ISO 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
This slide is specific to the work of the ISO 9001 revision. Working Groups can choose to deviate from the high level structure but are required to notify the TMB of the rationale for the change. The TMB does not have to approve, just be notified.
In the case of ISO 9001, SC2 chose to have these decisions submitted by SC2 and not directly by the Working Group

20. Annex SL
The high level structure and common text without ISO 9001:2015 management specific text is public information
It can be found at
Direct attendees to the contents of Annex SL and indicate that this text is not consensus text and not specific to ISO 9001.
It provides a general guideline of what the structure of the text looks like at its beginning stages (before the revision process began).
It should not be used to make changes to the high level structure.
Please note that Annex SL on its own should not be used to make changes to your management system

21. Future Relevance of ISO 9001:2008
(9001 WW Survey Result)
Let me discuss the WW survey that was conducted by SC2 to obtain feedback from users as well as non-users
Approximately 12,000 responses were received on the survey.
One of the question was related to whether 9001:2008 will remain relevant in the future in the “as-is” format. The chart above tells you the results.
64% of respondents had provided suggestions of improvement and they indicated that if these improvements were made to 9001:2008, then the Standard will be okay

22. ISO 9001 - New Concept Importance
How important is it to incorporate the following concepts into ISO 9001?
Another question in the survey was related to future concepts. There were approximately 14 future concepts which were mentioned in the survey
The top 6 concepts that the respondents felt will be important to include in the future 9001 version are the ones that are highlighted on the slide

23. 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
The slide indicates summarized results of the survey
It tells you the five critical items that the users felt must be addressed
ISO Input
For Future (

24. 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 preventive actions
Use of process approach
Handling of Customer Complaints
Another survey project initiated by UNIDO, showed the weak areas for improvement in They are:
Emphasis on continual improvement
Constant focus on preventive actions
Root cause analysis and weak preventive actions
Use of process approach
Handling of Customer Complaints
To address these weak areas, a decision has to be made by SC2 whether guidance documents will be provided or white papers will be written on VODs will be developed to assist the users
Guidance Documents?
White Papers?
VoDs?

25. 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

26. 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

27. ISO 9001:2015 Revision
Timeline for the changes

28. ISO 9001:2015 Timeline + Transition period for certification 2015 2014
2013
May 2013 CD
(Committee Draft)
February 2014 DIS
(Draft International Standard)
February 2015 FDIS
(Final Draft International Standard)
September 2015 Published IS
(International Standard)
+ Transition period
for certification

29. Other Important Information
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

30. ISO 9001:2015 Revision
What organizations can do

31. I need to ensure my Organization . . .
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!

32. Organizational Opportunities
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

33. ISO 9001:2015 Revision
Product Support

34. ISO 9001: Product Support
Formal Transition Plan for certified organizations
Supporting guidance documents will be modified as needed (see
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

35. 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 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…

36. Stay Tuned! Additional updates and information will be made available as the change process proceeds

37. The End!