ISO 9001 Global Certification Numbers
Source: ISO Survey 2012
October 31st, 2013
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Dr. Nigel Croft
Dr. Nigel H. Croft is recognized as one of the world’s foremost experts in quality
management and conformity assessment of management systems. He has been actively
involved in quality since 1974, when he began his career in the British steel industry as a
student apprentice. Among his many professional activities, Dr. Croft currently holds senior
management positions and serves as non-executive board member of a number of
commercial and non-profit organizations in Europe, the Middle East, Asia and the Americas.
He holds the post of visiting professor at the Business School of UUM (University of North
Malaysia), one of the leading Management Universities in the region, and also acts as a
Lead Consultant for UNIDO, the United National Industrial Development Organization.
Within the standards development arena, Dr. Croftl has been an active member of
ISO/TC176 (the ISO Technical Committee responsible for the ISO 9000 series of standards)
since 1995, and currently serves as Chair of SC2, the subcommittee responsible for the ISO
9001 and ISO 9004 standards development. He also represents TC 176 at the strategic-level
ISO/ILAC/IAF Joint Working Group which provides oversight of global management systems
certification.
Born in the UK, but with dual British and Brazilian citizenship, Dr Croft holds a first class
honours degree in Natural Sciences from Cambridge University, England, and a Doctorate in
Materials Science from Sheffield University. He is a Chartered Engineer and Chartered
Quality Professional in the UK, a Fellow of the Chartered Quality Institute and a Senior
Member of the American Society for Quality.
October 31st, 2013
© DNV Business Assurance. All rights reserved.
4
ISO 9001:2015 – From CD to DIS
Dr Nigel H Croft
Chair, ISO/TC176/SC2 (Quality Systems)
(C) Nigel H Croft 2013 - All rights reserved
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Disclaimer
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Any opinions expressed by the presenter are
personal viewpoints, and no formal endorsement
of ISO, IAF, ISO/TC176 or ISO/CASCO should
be implied
Information about the revision of ISO 9001 is not
final and should not be used for making changes
to existing quality management systems.
(C) Nigel H Croft 2013 - All rights reserved
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Webinar Outline…………
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Background
ISO Directives “Annex SL” – the need for
harmonization of management system
standards
ISO 9001:2015 – what to expect
Transition arrangements
Q&A
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Background
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Overall Scenario of ISO/TC176
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Development of generic quality management system
standards that have broad application:
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all market sectors
both private and public organizations
Approx. 1,200,000 worldwide certifications to ISO 9001
BUT
 It’s about more than just “certification”
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“Certification to ISO 9001” should be a result of a well-implemented
quality management system!
Other ISO/TC 176 products are aimed to assist organizations in
improving their quality management system.
ISO engaging more with IAF and others to “defend the ISO Brand”
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ISO/TC176/SC2 Vision
“SC2’s products* are recognized and
respected worldwide, and used by
organizations as an integral component
of sustainable development”
* ISO 9001, ISO 9004, and other guidance documents
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ISO/TC176/SC2 Mission
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To develop, maintain and support a portfolio of
products that enable organizations to improve their
performance and to benefit from the implementation of
a robust quality management system.
To establish generic quality management system
requirements that provide the foundations to build
confidence in goods and services delivered
throughout the supply chain to organizations and
people worldwide.
To provide guidance and support, where needed, to
ensure the continued credibility of our products.
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3 core concepts*…………
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Identify the processes needed to achieve the
planned results
Continually monitor the risks (“Cause and
effect”)
Manage the processes and the system using
“Plan-Do-Check-Act”
* = Nigel Croft’s understanding
(C) Nigel H Croft 2013 - All rights reserved
“Annex SL” – the need
for harmonization
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Need for Alignment of
management system standards!
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ISO Joint Technical Coordination Group
(“JTCG”):
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Joint vision for management system standards
High level structure for all ISO management systems
standards
Identical sub-clause titles under the high level
structure
Generic core vocabulary for management system
standards
Aim is to make life easier for those who wish to
have a “single management system”
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ISO Directives Part 1:2012 “Annex SL”
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Incorporates the recommendations of the JTCG
work
Defines the common structure and format for all
new ISO management system standards and
revisions to existing standards
Common text (approx 30% or more of each
standard will be identical text)
Significant impact on future revisions of ISO
9001 and ISO 14001
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Revision of ISO 9001
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The Global Challenges for
Quality Management Systems
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Increased customer expectations for confidence in
products and services
Increasing use of QMS standards for global trade
Increasing use of ISO 9001 by various industry sectors
Credibility of 3rd party certification
Drive for greater efficiency (lean initiatives)
Increased sophistication of quality management tools
Increasing regulatory emphasis on public health and
safety (e.g., food; medical devices)
Multiple management systems standards, programs
and schemes.
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Key objectives for “ISO 9001:2015”
Extracts from ISO 9001:2015 “Design Specification”:
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Provide stable core set of requirements for next 10 years or so
Maintain current focus on effective process management to
produce desired outcomes
Take account of changes in QMS practices and technology since
the last major revision (in 2000)
Apply Annex SL of ISO Directives to enhance compatibility
& alignment with other ISO management system standards
Facilitate effective organizational implementation and effective
conformity assessment by 1st, 2nd and 3rd parties
Simplified language and writing styles to aid understanding
and consistent interpretations of requirements.
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Where we are now………
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2010 – 2012
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June 2013
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WG 24 develops and agrees Working Drafts
June 2013
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New Work Item Proposal and Design Specification for Revision approved
unanimously by ISO/TC176/SC2 membership
Nov 2012 – April 2013
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Preliminary meeting of WG24
Oct 2012
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Preparing the groundwork……….
Committee Draft circulated to SC2 membership for Ballot & Comment
Sept 2013
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Committee Draft approved (approx. 80% approval; 51 Yes; 11 No; 3 abstain)
Approx. 2800 comments received (compared to approx. 6000 for same stage
of Year 2000 revision)
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Some key changes...........
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Complete reformatting to align with “Annex SL”
“Goods and services” instead of “product”
More emphasis on addressing “risks & opportunities”
Elimination of the term “preventive action”
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the concept still remains, and is actually reinforced
throughout the standard (by addressing “risk”)
“External provision of goods and services” instead of
“purchasing” – includes outsourced processes
Elimination of specific requirements for
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Quality Manual
Management representative
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Some examples of what to expect
(Based on “Annex SL”)…..
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4.1 “Understanding the organization
and its context”
“The organization shall determine external and
internal issues that are relevant to its purpose
and that affect its ability to achieve the intended
outcome(s) of its “XXX” management system.”
NOTE: “XXX” = “quality”, “environmental”,
“information security” etc.
 ISO 9001:2015 might use the term “goods
and services” instead of “product”
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4.2 “Understanding the needs and
expectations of interested parties”
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“The organization shall determine
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the interested parties that are relevant to the XXX management
system, and
the related requirements of these interested parties”
ISO 9001 is likely to add text requiring the organization
to include
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direct customers
end users
suppliers, distributers, retailers or others involved in the supply chain
Regulators
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4.4 XXX management system
The organization shall establish, implement, maintain and
continually improve an XXX management system,
including the processes needed and their interactions,
in accordance with the requirements of this International
Standard.
(This is key to maintaining the “process approach”,
which will now be embedded in ALL ISO management
system standards)
(“Beefed-up” version of current clause 4.1 of ISO
9001:2008 likely to be incorporated into this clause)
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6.1 Actions to address risks &
opportunities
“The organization shall consider the issues referred to in 4.1 and the
requirements referred to in 4.2 and determine the risks and opportunities that
need to be addressed to
 assure the management system can achieve its intended outcome(s)
 prevent undesired effects
 realize opportunities for improvement.
The organization shall:
a) evaluate the need to plan actions to address these risks and
opportunities, and
b) where applicable
 integrate and implement these actions into its XXX management system
processes (see 8.1)
 ensure information will be available to evaluate if the actions have been
effective (see 9.1).”
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7.1 Resources
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The organization shall determine and provide
the resources needed for the establishment,
implementation, maintenance and continual
improvement of the quality management system.
Additional text for ISO 9001 likely to include:
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Infrastructure
Process environment
Monitoring & Measurement
Knowledge management
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Probable ISO 9001 “adders” for
Clause 8
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This is where most of the current ISO 9001:2008 Clause
7 will be included.
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Customer related processes
Operational planning
“Control of external providers” (Purchasing and outsourcing
addressed together)
“Creation or change of product” (Incorporates “design &
development” from ISO 9001:2008)
Product realization
Monitoring and measurement of product
Nonconforming goods and services
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Probable ISO 9001 “adders”
for Clause 9
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Customer satisfaction
Analysis and evaluation of data
Greater emphasis on product conformity
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What next?
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Nov 2013
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Nov 2013 – March 2014
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Face-to-face meeting to review results of DIS Ballot
April 2015
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Forecast publication of DIS for Ballot and Comment
Nov 2014
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WG 24 electronic working to develop “Draft DIS”
Probable face-to-face meeting of WG24 to agree on DIS text
April 2014
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WG 24 face-to-face meeting in Porto.
Review of “Strategic-level” comments
Disposition where possible of ALL comments
Define path forward for “sticky issues”
Publication of FDIS
Sept 2015
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Publication of ISO 9001:2015
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Concerns and criticisms…..
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Some do not like or accept the “Annex SL” approach
Concerns that some requirements are being “watered down”
(Design & Development; Calibration and others)
Concerns about “auditability” of some requirements
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Some want more prescriptive requirements
…. But some want less prescriptive requirements!!
Some ambiguous / inconsistent terminology in the CD
Introduction of the concept of “Relevant Interested parties”
“Elimination” of “Preventive action”; “Management Representative”;
“Quality Manual”
Concerns that new clause structure means we risk losing the
“Process Approach” (I strongly disagree!)
(C) Nigel H Croft 2013 - All rights reserved
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Additional possibilities:
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SC2 is looking at the possibility to develop
specific implementation guidance for ISO
9001:2015 (not decided yet)
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Generic implementation guidance (possibly to be
numbered as ISO 9002)
Updated guidance for small businesses
Service sector (revive and revise the old ISO 9004-2?)
Sector guidance (possible way to address concerns
from Automotive Sector?)
Application for “one-off” projects (updated ISO 10006)
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Transition to ISO 9001:2015
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Scheduled publication date September 2015
ISO/TC176, ISO/CASCO and IAF have
approved a 3-year transition period
All organizations will be strongly encouraged to
start the transition as soon as the DIS is
published (mid-2014)
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Aim is to avoid “peak” of audits to the new standard
near end of transition period
Avoid overload of CB resources
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What you should do now…….
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No immediate action required
Stay tuned to what’s happening with the
revision to ISO 9001
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“Risk-based thinking”
www.iso.org
Periodic updates will be made available by
ISO/TC176/SC2/WG23
Start working on understanding and
incorporating changes from mid-2014 (after
publication of the DIS)
(C) Nigel H Croft 2013 - All rights reserved
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THANK YOU! – ANY
QUESTIONS?
[email protected]
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Selected questions
 Why was risk integrated into the latest revision by the standard development team? How do
you see the future of QMS and other management systems aligning with enterprise risk
management?
 Dr. Croft, when we are developing requirements in a certifiable standard such as ISO 9001,
the “auditability” of the requirement is paramount; otherwise conformity assessment against
the standard becomes even more difficult. How is the “auditability” of requirements assessed
during the development phase?
 Dr. Croft, the ISO 9001:2008 very clearly stated which Procedures, at a minimum, are
required. I did not find any shall clauses as to which Procedure re required. Can you guide
me, please?
 Dr. Croft. This sub-clause is not strong enough. Delete and restate: "Ensure that process
approach is used," Reason: ISO 9001:2000 and ISO 2008 were promoting "Process
Approach in 4.1 a. through f." Most Registrar Auditors have not followed it. Make it
mandatory.
 Dr. Croft. 5.2 in the DIS states: "ensuring that quality policies and quality objectives are
established for the QMS". Does this mean that Top Management has to establish more than
one Quality Policy for the organization?
October 31st, 2013
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Thank you for your time.
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join us for a ½ day workshop.
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