ISO 9001:2015

Revision Overview

August 2013
ISO/TC 176/SC 2/WG23 N062
1

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

2
Date:

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
3
Date:

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

4
Date:

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 (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

5
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 (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
6
Date:

ISO 9001
ISO/TC 176/SC 2/WG23 N062

A change is coming

7
Date:

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
8
Date:

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
9
Date:

ISO/TC 176/SC 2/WG23 N062

ISO 9001:2015 Revision

Scope

10
Date:

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
11
Date:

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

12
Date:

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

13
Date:

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

14
Date:

ISO/TC 176/SC 2/WG23 N062

ISO 9001:2015 Revision

What users should know

15
Date:

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

16
Date:

High Level Structure - Common Text

Annex SL
Mandated by ISOs 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
17
Date:

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
18
Date:

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
19
Date:

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

20
Date:

Future Relevance of ISO 9001:2008

ISO/TC 176/SC 2/WG23 N062

(9001 WW Survey Result)

21
Date:

ISO 9001 - New Concept Importance

ISO/TC 176/SC 2/WG23 N062

How important is it to incorporate the following concepts into ISO 9001?

22
Date:

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
23
Date:

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
preventive actions
ISO/TC 176/SC 2/WG23 N062

Use of process approach

Handling of Customer Complaints

Guidance Documents?
White Papers?
VoDs?
24
Date:

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
25
Date:

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
26
Date:

ISO/TC 176/SC 2/WG23 N062

ISO 9001:2015 Revision

Timeline for the changes

27
Date:

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)
28
Date:

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
29
Date:

ISO/TC 176/SC 2/WG23 N062

ISO 9001:2015 Revision

What organizations can do

30
Date:

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!
31
Date:

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

32
Date:

ISO/TC 176/SC 2/WG23 N062

ISO 9001:2015 Revision

Product Support

33
Date:

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
34
Date:

ISO/TC 176/SC 2/WG23 N062

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:

ISO/TC 176/SC 2/WG23 N062

Stay Tuned!
Additional updates and information
will be made available as the change
process proceeds

36
Date:

ISO/TC 176/SC 2/WG23 N062

37
Date: