ISO 9001 2015 Draft

ISO 9001:2015
REVISION OVERVIEW
AUGUST 2013
ISO/TC 176/SC 2/WG23 N062
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
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
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
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
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
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)*
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
ISO 9001
A change is coming
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
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
ISO 9001:2015 Revision

Scope
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
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
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
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

What users should know
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
HIGH LEVEL STRUCTURE COMMON

TEXT
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
High Level Structure (HLS)
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
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
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 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
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
Future Relevance of ISO

9001:2008
(9001 WW Survey Result)
ISO 9001 - New Concept

How important is it to incorporate the following concepts into ISO 9001?
Importance
WORLD-WIDE SURVEY - KEY USER

INPUTS
ISO 9001, as it is, must change to
ISO Input
For Future
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
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
Use of process approach

Handling of Customer Complaints
Guidance Documents?
White Papers?
VoDs?
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
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

Timeline for the changes
ISO 9001:2015 TIMELINE
+ Transition period
for certification
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

What organizations can do
I need to ensure my
Organization
. . . on and is
Knows what is going
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!
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

Product Support
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
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
STAY TUNED!
ADDITIONAL UPDATES AND
INFORMATION WILL BE MADE
AVAILABLE AS THE CHANGE
PROCESS PROCEEDS

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ISO 9001:2015

ISO/TC 176/SC 2/WG23 N062

ISO/TC 176/SC 2/WG23 N062

ISO/TC 176/SC 2/WG23 N062

ISO/TC 176/SC 2/WG23 N062

ISO = International Organization for Standardization

Made up of over 100 National Standards Bodies (NSBs)

Almost 20,000 standards in the ISO portfolio

All standards are based on INTERNATIONAL CONSENSUS

ISO standards are usually developed by its Technical Committees

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

ISO 9001:2015 is being developed by a specific SC2 Working Group

WG24 is composed of international experts nominated by their NSB

WG23 is responsible for Communications and Product Support

ISO 9001:2015 - DEVELOPMENT PROCESS

ISO/TC 176/SC 2/WG23 N062

Systematic Review and New Work Item

ISO/TC 176/SC 2/WG23 N062

ISO/TC 176/SC 2/WG23 N062

WHAT IS BEING CONSIDERED?

ISO/TC 176/SC 2/WG23 N062

International experts nominated by

ISO/TC 176/SC 2/WG23 N062

ISO 9001:2015 Revision

DESIGN SPECIFICATION STRATEGIC

ISO/TC 176/SC 2/WG23 N062

Take account of changes in quality management

Ensure that requirements in this standard reflect

DESIGN SPECIFICATION CHANGE

ISO/TC 176/SC 2/WG23 N062

Increase confidence in an organization's

Enhance an organization's ability to satisfy

Reasons For The Changes

ISO/TC 176/SC 2/WG23 N062

In the last 25 years, many other

Reasons For The Changes

ISO/TC 176/SC 2/WG23 N062

Decrease the emphasis on

ISO/TC 176/SC 2/WG23 N062

ISO 9001:2015 Revision

ISO/TC 176/SC 2/WG23 N062

The customer remains the primary

HIGH LEVEL STRUCTURE COMMON

ISO/TC 176/SC 2/WG23 N062

High level structure, identical core text and common

High Level Structure (HLS)

ISO/TC 176/SC 2/WG23 N062

APPLYING ANNEX SL TO ISO

ISO/TC 176/SC 2/WG23 N062

9001 standard using the new structure as

ISO/TC 176/SC 2/WG23 N062

The high level structure and

Future Relevance of ISO

ISO/TC 176/SC 2/WG23 N062

(9001 WW Survey Result)

ISO/TC 176/SC 2/WG23 N062

ISO 9001 - New Concept

ISO/TC 176/SC 2/WG23 N062

WORLD-WIDE SURVEY - KEY USER