ISO/TC 176/SC 2/WG23 N062 ISO/TC 176/SC 2/WG23 N062
ISO 9001:2015
ISO 9001:2015
Revision Overview Revision OverviewAugust 2013
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Introduction
Introduction
This presentation has been developed by the
This presentation has been developed by the
Communications and Product Support group
Communications and Product Support group
of ISO/TC176/SC2, the ISO subcommittee
of ISO/TC176/SC2, the ISO subcommittee
responsible for the ISO 9001 and ISO 9004
responsible for the ISO 9001 and ISO 9004
standards, among others
standards, among others
It provides basic information about the
It provides basic information about the
revision to ISO 9001, free of charge, to
revision to ISO 9001, free of charge, to
interested parties, and will be updated
interested parties, and will be updated
periodically as the revision progresses
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Disclaimer
Disclaimer
Any claims or statements made by
Any claims or statements made by
the presenter
the presenter
based on this presentation represent their own
based on this presentation represent their own
opinions and/or interpretatio
opinions and/or interpretatio
n, and
n, and
are not
are not
formally endorsed by ISO or its subcommittee
formally endorsed by ISO or its subcommittee
TC176/SC2, responsible for the ISO 9001
TC176/SC2, responsible for the ISO 9001
revision
revision
This presentation includes information related to
This presentation includes information related to
the status of the revision process as of JULY
the status of the revision process as of JULY
2013
2013
Further changes are likely as
Further changes are likely as
the revision
the revision
process progresses, so you
process progresses, so you
should NOT make
should NOT make
changes to your management system at this
changes to your management system at this
stage
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Outline
Outline
A change to ISO 9001 is coming
A change to ISO 9001 is coming
Why this change is taking place (rationale for
Why this change is taking place (rationale for
the changes)
the changes)
What users of ISO 9001 should know
What users of ISO 9001 should know
Timeline
Timeline
–
–
target is to publish in September
target is to publish in September
2015 (ISO 9001:2015)
2015 (ISO 9001:2015)
Organizational Opportunities
Organizational Opportunities
Product Support
Product Support
Expect further updates as this process
Expect further updates as this process
evolves
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ISO Facts
ISO Facts
ISO = International Organization for Standardization
ISO = International Organization for Standardization
̶
̶
Based in Switzerland
Based in Switzerland
̶
̶
Made up of over 100 National Standards Bodies (―NSB’s‖)
Made up of over 100 National Standards Bodies (―NSB’s‖)
̶
̶
Almost 20,000 standards in the ISO portfolio
Almost 20,000 standards in the ISO portfolio
̶
̶
All standards are based on INTERNATIONAL CONSENSUS
All standards are based on INTERNATIONAL CONSENSUS
ISO standards are usually developed by its Technical
ISO standards are usually developed by its Technical
Committees (―TC’s‖) and Sub
Committees (―TC’s‖) and Sub
-
-
committees (―SC’s‖)
committees (―SC’s‖)
̶
̶
ISO/TC176/SC2 (Quality Systems) is responsible for ISO 9001
ISO/TC176/SC2 (Quality Systems) is responsible for ISO 9001
ISO 9001:2015 is being developed by a
ISO 9001:2015 is being developed by a
specific SC2
specific SC2
Working Group (―WG24‖)
Working Group (―WG24‖)
̶
̶
WG24 is composed of international experts nominated by their NSB or
WG24 is composed of international experts nominated by their NSB or
from formal liaison member to ISO (typically in
from formal liaison member to ISO (typically in
dustry associations)
dustry associations)
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ISO 9001:2015 - Development Process
ISO 9001:2015 - Development Process
Agreement on the need for revision*
Agreement on the need for revision*
̶
̶ ―Systematic Review‖ and ―New Work Item‖―Systematic Review‖ and ―New Work Item‖
Agreement
Agreement
on the scope and
on the scope and
objectives (―Design Specification‖)*
objectives (―Design Specification‖)*
Working Drafts (―WD’s‖)
Working Drafts (―WD’s‖)
̶̶ Preliminary drafting by international experts nominated by ISO member bodiesPreliminary drafting by international experts nominated by ISO member bodies
̶
̶ WD’sWD’s are very rough documents - not are very rough documents - not normally made widely availablenormally made widely available
Committee Draft (―CD‖)*
Committee Draft (―CD‖)*
̶
̶ Once preliminary WDs have reached an acceptable level of maturity, Once preliminary WDs have reached an acceptable level of maturity, they arethey are
―uprated‖ to
―uprated‖ to CD that is formally circulated to ISO Member bodiesCD that is formally circulated to ISO Member bodies
̶
̶ NSB’s are expected to convene national interested parties to comment on CDNSB’s are expected to convene national interested parties to comment on CD
Draft International Standard (―DIS‖)*
Draft International Standard (―DIS‖)*
̶̶ Published after approval of CD by formal ballot, and incorporation of pertinentPublished after approval of CD by formal ballot, and incorporation of pertinent
comments
comments
Final draft international
Final draft international
standard (―FDIS‖)*
standard (―FDIS‖)*
̶
̶ Published after formal approval of the DIS, and incorporation of pertinentPublished after formal approval of the DIS, and incorporation of pertinent
comments
comments
International Standard
International Standard
̶
̶ Published after approval of the FDISPublished after approval of the FDIS
̶
̶ Subject to ―systematic review‖ every 5 yearsSubject to ―systematic review‖ every 5 years
* = B a l
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ISO 9001
ISO 9001
A
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ISO Standards are reviewed every five years to
ISO Standards are reviewed every five years to
ensure
ensure
they stay up-to-date
they stay up-to-date
–
–
revisions are part of the ISO
revisions are part of the ISO
process and are to be expected
process and are to be expected
A formal global review of ISO 9001
A formal global review of ISO 9001
was completed in
was completed in
2012 amo
2012 amo
ng ISO
ng ISO
member b
member b
odies.
odies.
This resu
This resu
lted in
lted in
a
a
decision to revise the standard
decision to revise the standard
As with all ISO standards, this will be a
As with all ISO standards, this will be a
consensus
consensus
process
process
̶
̶
All ISO’s National Member Bodies (NMBs) and
All ISO’s National Member Bodies (NMBs) and
official liaison members nominate experts to
official liaison members nominate experts to
participate in the drafting process
participate in the drafting process
̶
̶
Drafts of ISO 9001 w
Drafts of ISO 9001 w
ill circulated for comments
ill circulated for comments
and balloted at appropriate stages by
and balloted at appropriate stages by
NMBs
NMBs
Work on the revision has already begun
Work on the revision has already begun
Background Information
Background Information
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What is being considered?
What is being considered?
International experts nominated by ISO
International experts nominated by ISO
member bodies looked at a number of
member bodies looked at a number of
items
items
to help guide revision activities:
to help guide revision activities:
–
–
an extensive web-based user survey
an extensive web-based user survey
–
–
new quality concepts and ideas for
new quality concepts and ideas for
inclusion in ISO 9001
inclusion in ISO 9001
–
–
revised quality management principles
revised quality management principles
–
–
formal interpretations of ISO 9001:2008
formal interpretations of ISO 9001:2008
–
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ISO 9001:2015 Revision
ISO 9001:2015 Revision
Scope
Scope
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Design Specification Strategic Intent
Design Specification Strategic Intent
Take account of changes in quality management
Take account of changes in quality management
systems practices and technology since its last
systems practices and technology since its last
major revision (2000) and to provide a stable core
major revision (2000) and to provide a stable core
set of requirements for the next 10 years
set of requirements for the next 10 years
or more
or more
Ensure that requirements in this standard
Ensure that requirements in this standard
reflect
reflect
the changes in the increasingly complex,
the changes in the increasingly complex,
demanding, and dynamic environments in which
demanding, and dynamic environments in which
organizations operate
organizations operate
Ensure that requirements are stated to
Ensure that requirements are stated to
facilitate
facilitate
effective implementation by organizations and
effective implementation by organizations and
effective conformity assessment, as applicable
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Design Specification Change Criteria
Design Specification Change Criteria
Increase confidence in an
Increase confidence in an
organization's
organization's
ability to provide conforming goods and/or
ability to provide conforming goods and/or
services
services
Enhance an organization's ability to satisfy
Enhance an organization's ability to satisfy
its customers
its customers
Enhance customer confidence in quality
Enhance customer confidence in quality
management system
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In the last
In the last
25 years, many other
25 years, many other
Management Systems Standards have
Management Systems Standards have
come into use world wide
come into use world wide
Organizations that use multiple
Organizations that use multiple
Management System Standards are
Management System Standards are
increasingly demanding a common format
increasingly demanding a common format
and language that is
and language that is
aligned between
aligned between
those standards
those standards
Reasons For The Changes
Reasons For The Changes
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Decrease the emphasis on
Decrease the emphasis on
Documentation
Documentation
Increase the emphasis on
Increase the emphasis on
Achieving
Achieving
Value
Value
for the Organization and its
for the Organization and its
customers
customers
Increase emphasis on
Increase emphasis on
Risk Management
Risk Management
to achieve objectives
to achieve objectives
Reasons For The Changes
Reasons For The Changes
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ISO 9001:2015 Revision
ISO 9001:2015 Revision
What users should know
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What is changing?
What is changing?
New concepts are being considered
New concepts are being considered
The customer remains the primary
The customer remains the primary
focus
focus
A new common ISO format has been
A new common ISO format has been
developed for use across all Management
developed for use across all Management
System Standards
System Standards
Please note that since the
Please note that since the
contents are under development, there may be further changes
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High Level Structure - Common Text
High Level Structure - Common Text
Annex SL
Annex SL
Mandated by ISO’s Technical
Mandated by ISO’s Technical
Management
Management
Board (TMB)
Board (TMB)
High level structure, identical core text and
High level structure, identical core text and
common terms and core definitions for use in
common terms and core definitions for use in
all Management System Standards
all Management System Standards
Purpose - Enhance the consistency and
Purpose - Enhance the consistency and
alignment of
alignment of
different management system
different management system
standards
standards
Organizations who implement a single
Organizations who implement a single
system
system
addressing multiple standards (e.g. QMS, EMS,
addressing multiple standards (e.g. QMS, EMS,
ISMS etc) will see the
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High Level Structure (HLS)
High Level Structure (HLS)
1. Scope
1. Scope
2.
2.
Normative
Normative
references
references
3.
3.
Terms
Terms
and
and
definitions
definitions
4.
4.
Context
Context
of
of
the
the
organization
organization
•
•
Understanding the
Understanding the
organization and its context
organization and its context
••
Needs and requirements
Needs and requirements
••
Scope
Scope
••
Management System
Management System
5. Leadership
5. Leadership
•
•
General
General
••
Management commitment
Management commitment
••
Policy
Policy
••
Roles, responsibility and
Roles, responsibility and
authority
authority
6. Planning
6. Planning
•
•
Actions to address risks &
Actions to address risks &
opportunities
opportunities
••
Objectives and plans to
Objectives and plans to
achieve them
achieve them
7. Support
7. Support
• •Resources
Resources
• •Competence
Competence
• •Awareness
Awareness
• •Communication
Communication
••
Documented information
Documented information
8. Operation
8. Operation
•
•
Operational planning and
Operational planning and
control
control
9. Performance evaluation
9. Performance evaluation
•
•
Monitoring, measurement,
Monitoring, measurement,
analysis & evaluation
analysis & evaluation
•
•
Internal audit
Internal audit
•
•
Management review
Management review
10. Improvement
10. Improvement
•
•
Non conformity and
Non conformity and
corrective action
corrective action
•
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Applying Annex SL to ISO 9001:2015
Applying Annex SL to ISO 9001:2015
The objective is to
The objective is to
develop the revised ISO
develop the revised ISO
9001 standard using the new structure as
9001 standard using the new structure as
the foundation
the foundation
TC 176/SC2 plays an active role in I
TC 176/SC2 plays an active role in I
SO’s
SO’s
Joint Technical Coordination Group that is
Joint Technical Coordination Group that is
responsible for the development of Annex
responsible for the development of Annex
SL and any difficulties in applying Annex
SL and any difficulties in applying Annex
SL will be referred back to this group and
SL will be referred back to this group and
to ISO/TMB
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Annex SL
Annex SL
The high level structure and
The high level structure and
common
common
text without
text without
ISO 9001:2015 management
ISO 9001:2015 management
specific text is public information
specific text is public information
It can be found at
It can be found at
www.iso.org/directives
www.iso.org/directives
Please note that A
Please note that A
nnex SL on its ow
nnex SL on its ow
n should not be used to make
n should not be used to make
changes to your management system
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Future Relevance of ISO 9001:2008
Future Relevance of ISO 9001:2008
(9001 WW Survey Result)
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ISO 9001 - New Concept Importance
ISO 9001 - New Concept Importance
How i
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World-wide Survey - Key User Inputs
World-wide Survey - Key User Inputs
ISO 9001, as it is, must change to
ISO 9001, as it is, must change to
continue be relevant
continue be relevant
Integrate with other MSS (EMS etc.)
Integrate with other MSS (EMS etc.)
Provide one integral approach to the
Provide one integral approach to the
managemen
managemen
t of
t of
the organization for
the organization for
Leadership commitment &
Leadership commitment &
understan
understan
ding,
ding,
strategic planning,
strategic planning,
management buy-in
management buy-in
Need to work with ISO/CASCO and IAF
Need to work with ISO/CASCO and IAF
to ensure efficiency/effectiveness of
to ensure efficiency/effectiveness of
audits and address problems in
audits and address problems in
certification audits
certification audits
Include tools and risk management
Include tools and risk management
(
(
ISO Input ISO Input For Future For FutureO O / / T T C C 1 1 7 7 6 6 / / S S C C 2 2 / / W W G G 2 2 3 3 N N 0 0 6 6 2 2
Weak Areas of Implementation
Weak Areas of Implementation
Emphasis
Emphasis
on
on
continual
continual
improvement
improvement
Constant
Constant
focus
focus
on
on
preventive
preventive
actions
actions
Root cause analysis and weak
Root cause analysis and weak
preventive actions
preventive actions
Use
Use
of
of
process
process
approach
approach
Handling
Handling
of
of
Customer
Customer
Complaints
Complaints
Guidance Documents?
Guidance Documents?
White Papers?
White Papers?
VoDs?
VoDs?
ISO 9001ISO 9001——Its relevance and impact Its relevance and impact in Asian Developing Economiin Asian Developing Economies: Project initiated by es: Project initiated by UNIDO,UNIDO,
funded by Norad and supported with technical inputs by ISO and the IAF.
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What product support can I expect?
What product support can I expect?
Transition plan (timeframe for certification)
Transition plan (timeframe for certification)
Supporting guidance documents
Supporting guidance documents
Correlation annex (map of the changes)
Correlation annex (map of the changes)
FAQs (Frequently asked Questions)
FAQs (Frequently asked Questions)
ISO Quality Systems website updates
ISO Quality Systems website updates
Other ISO 9001 related products
Other ISO 9001 related products
Summary of changes between ISO 9000,
Summary of changes between ISO 9000,
ISO 9001 and ISO 9004
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The Committee Draft (CD) is the first
The Committee Draft (CD) is the first
opportunity for the draft standard to be
opportunity for the draft standard to be
scrutinized by a wider audience, beyond the
scrutinized by a wider audience, beyond the
nominated experts in WG24
nominated experts in WG24
National Member Bodies of ISO are required
National Member Bodies of ISO are required
to VOTE on the CD, and may provide
to VOTE on the CD, and may provide
comments
comments
Comments received will be addressed during
Comments received will be addressed during
the WG24 meeting in November 2013
the WG24 meeting in November 2013
Work is currently on schedule according to
Work is currently on schedule according to
the Project Plan, with a planned publication
the Project Plan, with a planned publication
date of September 2015
date of September 2015
Users Should Know
Users Should Know
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ISO 9001:2015 Revision
ISO 9001:2015 Revision
Ti
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ISO 9001:2015 Timeline
ISO 9001:2015 Timeline
May 2013 CD
May 2013 CD
(Committee (Committee Draft) Draft)February 2014 DIS
February 2014 DIS
(Draft International (Draft International Standard) Standard)February 2015 FDIS
February 2015 FDIS
(Final Draft International
(Final Draft International
Standard) Standard)
September 2015
September 2015
Published IS
Published IS
(International Standard) (International Standard)2015
2015
2014
2014
2013
2013
+ Transition period
+ Transition period
for certification
for certification
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Impact on other standards that are part
Impact on other standards that are part
of the family
of the family
̶
̶
Expect changes to industry-specific
Expect changes to industry-specific
standards to follow as these are updated
standards to follow as these are updated
over time
over time
̶
̶
Expect changes to supporting
Expect changes to supporting
documents as these are modified in the
documents as these are modified in the
future
future
Expect further news updates as this
Expect further news updates as this
process evolves
process evolves
Other Important Information
Other Important Information
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ISO 9001:2015 Revision
ISO 9001:2015 Revision
What organizations can do
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Knows what is going on and
Knows what is going on and
is ready to
is ready to
implement the new requirements
implement the new requirements
Takes full advantage of the revision of
Takes full advantage of the revision of
ISO 9001 to improve business
ISO 9001 to improve business
performance
performance
Remember, don’t make any changes
Remember, don’t make any changes
yet!
yet!
I need to ensure my Organization . . .
I need to ensure my Organization . . .
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Integrate their activities within the scope
Integrate their activities within the scope
of multiple Management System
of multiple Management System
Standards
Standards
Decrease the emphasis on
Decrease the emphasis on
documentation when this is not
documentation when this is not
mandated or does not add value
mandated or does not add value
Organizational Opportunities
Organizational Opportunities
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ISO 9001:2015 Revision
ISO 9001:2015 Revision
Product Support
Product Support
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ISO 9001:2015 - Product Support
ISO 9001:2015 - Product Support
Formal T
Formal T
ransition Plan for
ransition Plan for
certified
certified
organizations
organizations
Supporting guidance documents will be
Supporting guidance documents will be
modified as needed (see
modified as needed (see
www.iso.org
www.iso.org
)
)
Correlation Annex
Correlation Annex
–
–
showing the changes
showing the changes
from ISO 9001:2008 to
from ISO 9001:2008 to
ISO 9001:2015
ISO 9001:2015
Website with FAQs
Website with FAQs
Other products will be developed as needed
Other products will be developed as needed
to support the new requirements
to support the new requirements
Relationship between ISO 9001 and ISO
Relationship between ISO 9001 and ISO
9004
9004
will be updated and clarified
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Supporting Guidance Documents
Supporting Guidance Documents
Introduction and Support Package:
Introduction and Support Package:
̶
̶
Guidance on the Documentation
Guidance on the Documentation
Requirements of ISO 9001:2015
Requirements of ISO 9001:2015
̶
̶
Guidance on some of the new, changed and
Guidance on some of the new, changed and
frequently used words found in the
frequently used words found in the
ISO 9000
ISO 9000
family of standards
family of standards
̶
̶
Guidance on the Concept and Use of t
Guidance on the Concept and Use of t
he
he
Process Approach for management
Process Approach for management
systems
systems
̶
̶
Guidance on Outsourced Processes
Guidance on Outsourced Processes
̶
̶
Implementation Guidance for organizations
Implementation Guidance for organizations
currently using ISO 9001:2008
currently using ISO 9001:2008
̶
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Stay Tuned!
Stay Tuned!
Additional updates and information
Additional updates and information
will be made available as the change
will be made available as the change
process proceeds
process proceeds
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