Revision Overview: August 2013

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

1
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
2
Date:
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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Date:
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 4
Date:
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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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”)*
̶ 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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Date:
ISO 9001
A change is coming
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Date:
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:
– 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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Date:
ISO 9001:2015 Revision
Scope
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Date:
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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Date:
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
12
Date:
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
13
Date:
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
14
Date:
What users should know
15
Date:
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 the

contents are under development, there may be further changes
16
Date:
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)
1. Scope 7. Support
2. Normative references • Resources
3. Terms and definitions • Competence
4. Context of the organization • Awareness
• Understanding the • Communication
organization and its context • Documented information
• Needs and requirements 8. Operation
• Scope • Operational planning and
• Management System control
5. Leadership 9. Performance evaluation
• General • Monitoring, measurement,
• Management commitment analysis & evaluation

• Policy • Internal audit
• Roles, responsibility and • Management review
authority 10. Improvement
6. Planning • Non conformity and
• Actions to address risks & corrective action
opportunities • Continual Improvement
• Objectives and plans to
achieve them
18
Date:
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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Date:
Annex SL
 The 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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Date:
Future Relevance of ISO 9001:2008
(9001 WW Survey Result)
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Date:
ISO 9001 - New Concept Importance
How important is it to incorporate the following concepts into ISO 9001?
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Date:
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
ISO Input
For Future 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
preventive actions
 Use of process approach
 Handling of Customer Complaints
Guidance Documents?
White Papers?
VoDs?
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Date:
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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Date:
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:
Timeline for the changes
27
Date:
ISO 9001:2015 Timeline
2013 2014 2015
May 2013 CD
(Committee
Draft)
+ Transition period
February 2014 DIS
for certification
(Draft International
Standard)
February 2015 FDIS

(Final Draft International
Standard)
September 2015
Published IS
(International Standard)
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Date:
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
29
Date:
What organizations can do
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Date:
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!
31
Date:
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
32
Date:
Product Support
33
Date:
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:
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…
35
Date:
Stay Tuned!
Additional updates and information
will be made available as the change
process proceeds
36
Date:
Date:
37

Revision Overview: August 2013

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ISO 9001:2015

ISO/TC 176/SC 2/WG23 N062

 It provides basic information about the

revision to ISO 9001, free of charge, to

2015 (ISO 9001:2015)

 ISO standards are usually developed by its Technical

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

 ISO 9001:2015 is being developed by a specific SC2

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

* = Balloted by ISO member bodies

̶ All ISO’s National Member Bodies (NMBs) and

– revised quality management principles

 Enhance an organization's ability to satisfy

 Enhance customer confidence in quality

 Organizations that use multiple

and language that is aligned between

 Increase the emphasis on Achieving

 Increase emphasis on Risk Management

 The customer remains the primary focus

 A new common ISO format has been

Please note that since the

alignment of different management system

• Management commitment analysis & evaluation

 TC 176/SC2 plays an active role in ISO’s

responsible for the development of Annex

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

 Need to work with ISO/CASCO and IAF

 Emphasis on continual improvement

 Other ISO 9001 related products

 Comments received will be addressed during

February 2015 FDIS

documents as these are modified in the

 Takes full advantage of the revision of

 Remember, don’t make any changes

 Decrease the emphasis on

mandated or does not add value

 Website with FAQs

Process Approach for management systems

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