Welcome To The Program

ISO 9001: 2008

Clock Ticking on ISO 9001 Users

Be Ready For The New Version
DISCLAIMER—While minimal change is expected to the standard during the next comment
period, the contents of the DIS are subject to change and should not be used in any contractual
or legally binding agreements.

10th October 2008 ISO 9001:2008 1

 About MEQMP
(Share, Exchange & Learn)

Formed in April 2005

To gather Quality Management Professionals

More than 1250 members from Middle East including

UAE, Kuwait, Qatar, Saudi Arabia, Bahrain, Oman, Iran,
Iraq, Jordan, Pakistan and India
Network of Consultants, Trainers, Auditors, Managers or
Coordinators
Programs for different management issues like Quality,
Environment, H & S and Knowledge management

10th October 2008 ISO 9001:2008 2

 Achievements
Conducted courses for IRCA accredited Lead
Auditor Course for different Management
Systems
Six Sigma Awareness
UK accredited Six Sigma Green Belt
UK accredited Online Six Sigma Green Belt
Contact: www.meqmp.com
http://groups.yahoo.com/group/meqmp
Email: president@meqmp.com

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 About the presentation
ISO standards an introduction
Change process
Reasons for the amendment
Scope of the amendment
Clause-by-clause review of changes
Timetable of next steps
Migration process

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 ISO standards an introduction
What is ISO?

170 countries
More than 17000 standards
Central office in Geneva, Switzerland
More than 1 Million certification for ISO 9001: 2000

Who pays for ISO?

ISO's national members according to country's GNP and trade figures

Sale of standards

Can anyone join ISO?

Not as individuals or as enterprises National standards institutes Full
members each have one vote
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 Who runs ISO?
President (For two years)

General secretary (Permanent position)

ISO Council (BOD)

Meet twice a year

ISO Members Total 170

(Participating 80 and observing 21 )

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 Participating & Observing
Countries
Participating Countries Observing Countries

Algeria ( IANOR ) Palestine ( PSI )

Iran ( ISIRI ) Syria ( SASMO )
Iraq ( COSQC ) Yemen ( YSMO )
Jordan ( JISM )
Kuwait ( KOWSMD )
Lebanon ( LIBNOR )
Libya ( LNCSM )
Oman ( DGSM )
Qatar ( QS )
Turkey ( TSE )
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 ISO Standards
Over 17000 International Standards
1100 new ISO standards are published every year
Automotive ISO/TS 16949:2002
Education IWA 2:2007
Energy PC 242, ISO 50001
Food safety ISO 22000:2005
Information security ISO/IEC 27001:2005
Medical devices ISO 13485:2003
Petroleum and gas ISO 29001:2003
Supply chain security ISO 28000:2007

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 Technical Committees
Total 245 TC 86Refrigeration and
air-conditioning
JTC 1Information TC 127Earth-moving
technology machinery
TC 11Boilers and TC 162Doors and
pressure vessels windows
TC 17Steel TC 176Quality
management and quality
TC 44Welding and allied assurance
processes
TC 207Environmental
TC 85Nuclear energy management

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 TC 176
TC 176 - Quality management and quality
assurance
Subcommittees
TC 176/SC 1 Concepts and terminology
TC 176/SC 2 Quality systems
TC 176/SC 3 Supporting technologies

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 TC 176 (Total 18)
ISO 9000:2005
Quality management systems --
Fundamentals and vocabulary
ISO 9001:2000
Quality management systems –
Requirements
ISO 9004:2000
Quality management systems --
Guidelines for performance
improvements
ISO 10002:2004
Quality management -- Customer
satisfaction -- Guidelines for
complaints handling in
organizations
ISO 10006:2003
Quality management systems --
Guidelines for quality
management in projects
10th October 2008 ISO 9001:2008
ISO 10012:2003
Measurement management
systems -- Requirements for
measurement processes and
measuring equipment
ISO/TR 10013:2001
Guidelines for quality
management system
documentation
ISO/TS 16949:2002
Quality management systems --
Particular requirements for the
application of ISO 9001:2000 for
automotive production and
relevant service part organizations
ISO 19011:2002
Guidelines for quality and/or
environmental management
systems auditing
11
 Example
A large chemical processing company was required by its major
customers to gain certification to ISO 9001 and to be
environmentally friendly. To address these issues, the company
leadership planned a comprehensive management strategy linking
their QMS and an environmental management system (EMS). A
thorough review of their business processes indicated that all
elements of ISO 9001 were applicable to their quality management
system and the Annex in ISO 9001 provided the information needed
to effectively link it to the ISO 14001 EMS standard. The company
used ISO/TR 10013 to guide the development of the required
documentation in its various production divisions, ISO 10015 for
guidance in the preparation of training plans for their employees and
ISO 19011 for auditing both the QMS and EMS. Management
achieved additional benefits and continual improvements using ISO
9000 and ISO 9004.

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 Process Model

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 History of Change
Not very old. The first standard was published in the year
1987.
It was revised in years 1994
The last revision was in 2000 which is the current
version known as ISO 9001:2000.
It will be revised again in the end of 2008 or early 2009,
and the new version will be called ISO 9001:200X.
A design specification was balloted during the year 2005.
Expected to contain little changes or additions to
requirements.
However, even small changes to the standard can
dramatically impact a user’s QMS.

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 Reason for Change
ISO 9001, like all standards is subject to periodic
review
Normally the review period is around 5 – 6 years
One Major One Minor
Proposed changes are more based on the
clarification of points already in the standard
rather than the inclusion of new requirements.
However, the proposed changes to ISO 9001’s
‘sister’ standard, ISO 9004

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 Current Change
Currently ISO TC 176 SC2 is working on
an amendment of ISO 9001:2000.
The main purpose of the amendment is to
enhance the clarity of the current version
of the ISO 9001:2000 standard
To enhance its compatibility with the latest
revision of the Environmental
Management Specification standard,
14001:2004.

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 Current Change
A number of users reported difficulty
transitioning to the 2000 edition of ISO 9001,
which incorporated major changes from earlier
editions, including a new clause structure.
No new requirement same clause numbers
No significant change
Clarification to existing requirements for more
consistency with ISO 14001
Mainly in Clause 7
Significant change in ISO 9004

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 Change Process
Standard process which is usually followed
The standard is reviewed by various working
groups and committees and suggestions are put
forward for amendments.
Amendments are incorporated into a draft
version of the standard which is known as a
Committee Draft (CD)
There may be more than 1 CD in which case
they are sequentially numbered e.g. CD1, CD2,
etc.

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 Change Process
Formal feedback to the CD’s can be
submitted by anyone.
Following feedback to the CD’s, a Draft
International standard (DIS) is published
and this is followed by the Final Draft
International Standard (FDIS) normally
represents what the finished standard will
look like barring punctuation errors etc.

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 Proposed changes
FDIS ISO 9001:2008 proposed changes:-

Clause 0.2 (Process approach)

Text added to emphasize the importance of
processes being capable of achieving desired
outputs
Clause 1.1 (Scope)
Clarification that “product” also includes
intermediate product
Explanation regarding statutory, regulatory and
legal requirements

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 Proposed changes
Clause 4.1 (General requirements)
Notes added to explain more about outsourcing
Types of control that may be applied to
outsourced processes
Relationship to clause 7.4 (Purchasing)
Clarification that outsourced processes are still
responsibility of the organization and must be
included in the quality management system

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 Proposed changes

Outsourced processes comply with all customer and

legal requirements.
New standard goes further by expecting you also to
specify the type, nature, and extent of control.
How you’re going to control outsourced processes?
How you choose to control an outsourced process
should be influenced by the potential impact it could
have on your products, whether or not process
control will be shared with the process supplier, and
whether or not adequate controls can be
contractually established using your purchasing
process.

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 Proposed changes
Clause 4.2.1 (Documentation)
Clarification that QMS documentation also
includes records which have an impact on your
QMS
Documents required by the standard may be
combined
ISO 9001 requirements may be covered by more
than one documented procedure
Clause 4.2.3 (Document control)
Clarification that only external documents
relevant to the QMS need to be controlled

10th October 2008 ISO 9001:2008 23

 Proposed changes
Clause 4.2.4 (Records control)
Editorial changes only (better alignment with ISO 14001)
Clause 5.5.2 (Management rep)
Clarifies that this must be a member of the organization’s
own management
Clause 6.2.1 (Human resources)
Clarification that competence requirements are relevant
for any personnel who are involved in the operation of
the quality management system
Clause 6.3 (Infrastructure)
More clear includes information systems as example

10th October 2008 ISO 9001:2008 24

 Proposed changes
Clause 6.4 (Work environment)
Clarifies that this includes conditions under which work is
performed and includes, for example physical,
environmental and other factors such as noise,
temperature, humidity, lighting, or weather

Clause 7.2.1 (Customer related processes)

Clarifies that post-delivery activities may include:
Actions under warranty provisions
Contractual obligations such as maintenance services
Supplementary services such as recycling or final
disposal

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 Proposed changes
Clause 7.3.1 (Design & development planning)
Clarifies that design and development review, verification
and validation have distinct purposes
These may be conducted and recorded separately or in
any combination as suitable for the product and the
organization
Clause 7.3.3(Design & development outputs)
Clarifies that information needed for production and
service provision includes preservation of the product
Clause 7.5.4 (Customer property)
Explains that both intellectual property and personal data
should be considered as customer property

10th October 2008 ISO 9001:2008 26

 Proposed changes
Clause 7.6 (Now retitled Control of Monitoring and
Measuring equipment)
Explanatory notes added regarding the use of computer
software: “Confirmation of the ability of computer
software to satisfy the intended application would
typically include its verification and configuration
management to maintain its suitability for use.”
Clause 8.2.1 (Customer satisfaction)
Note added to explain that monitoring of customer
perception may include input from sources such as
customer satisfaction surveys, customer data on
delivered product quality, user opinion surveys, lost
business analysis, compliments, and dealer reports

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 Proposed changes
Clause 8.2.3 (Monitoring / Measurement of
process)
Note added to clarify that when deciding
on appropriate methods, the organization
should consider impact on the conformity
to product requirements and on the
effectiveness of the quality management
system.

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 Validity of certifications to ISO
9001:2000

One year after publication of ISO

9001:2008 all accredited certifications
issued (new certifications or
recertification's) shall be to ISO
9001:2008.
Twenty four months after publication by
ISO of ISO 9001:2008, any existing
certification issued to ISO 9001:2000 shall
not be valid.

10th October 2008 ISO 9001:2008 29

 What to do?
Wait for the new standard
Clarify the doubts
Make changes accordingly
Conduct Internal audit and Management
Review
Ask the certification body for audit

10th October 2008 ISO 9001:2008 30

 Presented by
Muhammad Asim Baig
Group Business Improvement Consultant
Abdulla Fouad Holding
President
Middle East Quality Management Professionals
Cell: +966 507879405
Email: asim.baig@abdulla-fouad.com
president@meqmp.com
web: www.abdulla-fouad.com
www.meqmp.com

"Biggest room in the world is the room for improvement"

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