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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 = International Organization for Standardization

Based in Switzerland

Made up of over 100 National Standards Bodies (NSBs)

Almost 20,000 standards in the ISO portfolio

All standards are based on INTERNATIONAL CONSENSUS

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ISO standards are usually developed by its Technical


Committees (TCs) and Sub-committees (SCs)

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 (WDs)

Preliminary drafting by international experts nominated by ISO member bodies


WDs are very rough documents - not normally made widely available

Committee Draft (CD)*

ISO/TC 176/SC 2/WG23 N062

Once preliminary WDs have reached an acceptable level of maturity, they are
uprated to CD that is formally circulated to ISO Member bodies
NSBs 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/TC 176/SC 2/WG23 N062

ISO 9001

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 ISOs 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:

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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
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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

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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

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Annex SL
Mandated by ISOs 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)

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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
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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 ISOs 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

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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
Integrate with other MSS (EMS etc.)

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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
ISO Input
For Future

Include tools and risk management

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Weak Areas of Implementation


ISO 9001Its 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?
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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
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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
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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
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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, dont 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
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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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