1
Identify the Differences between
ISO9001:2000 and ISO 9001:2008
ISO9001:2000 ISO9001:2008
5 January 2009
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ISO9000
ISO9001 ISO9004
ISO 19011
ISO 9000 SERIES
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1982 - Work started
1987 - First publication ISO 9001:1987
1994 - Second edition ISO 9001:1994
2000 Third edition ISO 9001:2000
2008 Fourth edition ISO 9001:2008 (Latest)
ISO 9000 SERIES ISO 9001
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ISO 9000 Family amendment history
Definition Specification Guidance
ISO8042:1986
ISO9000:2000
ISO9000:2005
ISO9001/2/3:1987
ISO9001:2008
ISO9001:2000
ISO9001/2/3:1994
ISO9004:1987
ISO9004:1994
ISO9004:2000
ISO9004:2009
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TC176 Key Messages for ISO 9001 Amendment
project should be undertaken for a limited amendment
to ISO 9001:2000
in order to satisfy user needs, the amended standard
shall remain generic and be applicable to all sizes and
types of organization operating in any sector
the impact on the users shall be limited, and changes
will only be introduced where there are clear benefits to
users.
The current scope and purpose of the standard, the title
and the field of application shall be unchanged from ISO
9001:2000
Certification to ISO9001:2008 is not an upgrade,
organization certified to ISO9001:2000 should be the
same status
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TC176 Key Messages for ISO 9001 Amendment
...enhanced compatibility with ISO14001:2004 (in turns,
OHSAS18001:2007)
Improved clarity and easy for use, changes made only
there are benefits
Changes confined to minimized impact on users
The process model as shown in ISO 9001:2000, Figure 1,
shall remain unchanged.
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Key Value adding activities
Information flow
Figure 1 - Illustration of a process-based quality management system
Process (PDCA) Model
Highlighted Differences
between ISO9001:2000 and
ISO9001:2008
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This session consists of highlighted changes in
ISO9001:2008, but not an in-depth comprehensive
explanation of each clauses
Details of the changes between ISO9001:2000 and
ISO9001:2008 are given in Annex B Table B.1 of the
standard.
ISO 9001 : 2008 Amendment Highlights
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0.1 General
Highlighted changes: ISO9001:2008 adds organization
environment, changes, risk to factors that influence the
design and implementation of QMS.
The design and implementation of an organizations quality management
system is influenced by
a) its organizational environment, change in that environment, and the
risks associated with that environment [Added]
This International Standard can be used by internal and external parties, .,
the organizations ability to meet customer, statutory [Added] and regulatory
requirements applicable to the product [Added], and the organizations own
requirements.
ISO 9001 : 2008 Amendment Highlights
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0.2 Process approach
Highlighted changes: Definition of process approach is
clarified by adding to produce the desired outcome
The application of a system within an organization, together with the
identification and interactions of these processes, and their management to
produce the desired outcome [Added], can be referred to as the process
approach. (add for clarification)
ISO 9001 : 2008 Amendment Highlights
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1 Scope
Highlighted changes: ISO9001:2008 expands the use of
regulatory to statutory and regulatory and may be
expressed as legal requirements.
1.1 General
a) needs to demonstrate its ability to consistently provide product that meets
customer and applicable statutory [Added] and regulatory requirements, and
b) aims to enhance customer satisfaction through the effective application of
the system, including processes for continual improvement of the system and
the assurance of conformity to customer and applicable statutory [Added] and
regulatory requirements.
NOTE 1 In this International Standard, the term product applies to the product intended for,
or required by, a customer or the product realization processes. This applies to any
intended output resulting from [Added] product realization processes, including
purchasing.
NOTE 2 Statutory and regulatory requirements may be expressed as legal
requirements. [Added]
ISO 9001 : 2008 Amendment Highlights
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2 Normative reference
Only re-phrasing of sentence. The text has been
significantly reduced.
Updating version of ISO 9000 to 2005 version.
3 Terms and definitions
Only deleting explanation of supply chain terms,
Organisation replaced supplier; Supplier replaced
subcontractor. (i.e. Remark to explain the difference
between terminologies from ISO9001:1994 and
ISO9001:2000)
ISO 9001 : 2008 Amendment Highlights
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4 Quality Management System
4.1 General requirements
Highlighted changes: Product is now required to meet
customer and applicable statutory and regulatory
requirements.
Identify (the processes) was replaced by determine
a) determine [is amended from identify] the processes needed for the quality
management system and their application throughout the organization (see 1.2)