ISO 9001:2015
Revision Overview
August 2013
ISO/TC 176/SC 2/WG23 N062
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Introduction
ISO/TC 176/SC 2/WG23 N062
 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
ISO/TC 176/SC 2/WG23 N062
 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)
ISO/TC 176/SC 2/WG23 N062
 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/TC 176/SC 2/WG23 N062
 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”)*
̶
ISO/TC 176/SC 2/WG23 N062
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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
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ISO 9001
ISO/TC 176/SC 2/WG23 N062
A change is coming
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ISO/TC 176/SC 2/WG23 N062
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
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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:
ISO/TC 176/SC 2/WG23 N062
– 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/TC 176/SC 2/WG23 N062
ISO 9001:2015 Revision
Scope
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Design Specification Strategic Intent
ISO/TC 176/SC 2/WG23 N062
 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
ISO/TC 176/SC 2/WG23 N062
 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
ISO/TC 176/SC 2/WG23 N062
 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
ISO/TC 176/SC 2/WG23 N062
 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/TC 176/SC 2/WG23 N062
ISO 9001:2015 Revision
What users should know
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What is changing?
 New concepts are being considered
ISO/TC 176/SC 2/WG23 N062
 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)
ISO/TC 176/SC 2/WG23 N062
 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)
ISO/TC 176/SC 2/WG23 N062
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
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Applying Annex SL to ISO 9001:2015
ISO/TC 176/SC 2/WG23 N062
 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 SL
 The high level structure and common
text without ISO 9001:2015 management
specific text is public information
ISO/TC 176/SC 2/WG23 N062
 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
ISO/TC 176/SC 2/WG23 N062
(9001 WW Survey Result)
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ISO 9001 - New Concept Importance
ISO/TC 176/SC 2/WG23 N062
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
ISO/TC 176/SC 2/WG23 N062
 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
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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
ISO/TC 176/SC 2/WG23 N062
 Use of process approach
 Handling of Customer Complaints
Guidance Documents?
White Papers?
VoDs?
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What product support can I expect?
 Transition plan (timeframe for certification)
 Supporting guidance documents
 Correlation annex (map of the changes)
ISO/TC 176/SC 2/WG23 N062
 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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Users Should Know
ISO/TC 176/SC 2/WG23 N062
 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
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ISO/TC 176/SC 2/WG23 N062
ISO 9001:2015 Revision
Timeline for the changes
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ISO 9001:2015 Timeline
2013
2014
2015
May 2013 CD
(Committee
Draft)
ISO/TC 176/SC 2/WG23 N062
February 2014 DIS
(Draft International
Standard)
+ Transition period
for certification
February 2015 FDIS
(Final Draft International
Standard)
September 2015
Published IS
(International Standard)
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Other Important Information
 Impact on other standards that are part
of the family
ISO/TC 176/SC 2/WG23 N062
̶ 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
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ISO/TC 176/SC 2/WG23 N062
ISO 9001:2015 Revision
What organizations can do
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I need to ensure my Organization . . .
ISO/TC 176/SC 2/WG23 N062
 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
ISO/TC 176/SC 2/WG23 N062
 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/TC 176/SC 2/WG23 N062
ISO 9001:2015 Revision
Product Support
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ISO/TC 176/SC 2/WG23 N062
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 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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