Review of differences between Colour code: RED- Changes

in wording
ISO 9001:2000 and ISO 9001:2008 BLUE- Text deleted
VIOLET- New text
No colour code used where there is only change in word order

ISO 9001:2008 Clause Summary of change Impact of change

ISO 9001:2000 Clause

4.1 General requirements

4.1 General requirements
a) identify the processes
needed for the quality
management system and their
application throughout the
organization (see 1.2),
e) monitor, measure and
analyse these processes, and
a) determine the processes
needed for the quality
management system and their
application throughout the
organization (see 1.2),
e) monitor, measure where
applicable, and analyse these
processes, and
a) The word ‘identify’
has been replaced with
‘determine’
e) ‘Where applicable’
has been added to
measure
No impact with most
customers
Determine implies that
processes should be
defined and managed
effectively rather than just
identifying that a process is
needed.
The change allows the
freedom not to measure
some processes.
Where measurement is not
carried out the client will
need to explain why it is not
necessary to measure a
process.

1
Review of differences between Colour code: RED- Changes
in wording
ISO 9001:2000 and ISO 9001:2008 BLUE- Text deleted
VIOLET- New text
No colour code used where there is only change in word order

ISO 9001:2008 Clause Summary of change Impact of change

ISO 9001:2000 Clause

Where an organization chooses Where an organization chooses ‘With requirements’

to outsource any process that to outsource any process that changed to ‘to
affects product conformity with affects product conformity to requirements’ The need to ‘define’ rather
requirements, the organization requirements, the organization than ‘identify’ means
shall ensure control over such shall ensure control over such control of outsourcing now
processes. processes. needs to be adequately
Control of such outsourced The type and extent of control ‘Identified’ changed to described.
processes shall be identified to be applied to these ‘defined’.
within the quality management outsourced processes shall be This should only effect
system. defined within the quality customers with minimal
management system. detail in their QMS
NOTE Processes needed for the NOTE 1 Processes needed for Note 1 ‘analysis and This adds two processes
quality management system the quality management system improvement ‘ added that will need to be
referred to above should include referred to above include to list of process included. Some customers
processes for management processes for management inclusions will already have these but
activities, provision of activities, provision of it will now need to be
resources, product realization resources, product realization, clearer.
and measurement. measurement, analysis and
improvement.

2
Review of differences between
in wording
ISO 9001:2000 and ISO 9001:2008
ISO 9001:2008 Clause
ISO 9001:2000 Clause
NOTE 2 An “outsourced
process” is a process that the
organization needs for its
quality management system
and which the organization
chooses to have performed by
an external party.
NOTE 3 Ensuring control over
outsourced processes does not
absolve the organization of the
responsibility of conformity to
all customer, statutory and
regulatory requirements. The
type and extent of control to be
applied to the outsourced
process can be influenced by
factors such as
a) the potential impact of the
outsourced process on the
organization’s capability to
provide product that conforms
to requirements;
Colour code: RED- Changes
BLUE- Text deleted
VIOLET- New text
No colour code used where there is only change in word order
Summary of change Impact of change
Note 2 has been added Clarification text only.
defining an outsourced
process
Note 3 Reinforces the In theory no change to what
Clients responsibility should have been checked
for control over before.
outsourced processes Control should still be
and expands on the demonstrated within the
type of control that organisation.
may be applied.
Appropriate records will
need to be maintained.
3
Review of differences between
in wording
ISO 9001:2000 and ISO 9001:2008
ISO 9001:2000 Clause
4.2.1 General
c) documented procedures
required by this International
Standard,
d) documents needed by the
organization to ensure the
effective planning, operation
and control of its processes, and
e) records required by this
International Standard (see
4.2.4).
ISO 9001:2008 Clause
b) the degree to which the
control for the process is
shared;
c) the capability of achieving
the necessary control through
the application of 7.4.
4.2.1 General
c) documented procedures and
records required by this
International Standard, and
d) documents, including
records, determined by the
organization to be necessary to
ensure the effective planning,
operation and control of its
processes.
Colour code: RED- Changes
BLUE- Text deleted
VIOLET- New text
No colour code used where there is only change in word order
Summary of change Impact of change
Need to check monitoring
and measurement
processes cover
outsourcing
Need to check purchasing
processes cover
outsourcing
c) & d) No impact
The clauses have been
restructured but the
intent stays the same.
This puts more onus on the
organisation to show what
documents and records it
has and why. And also why
it might not have some
records.
The requirements for No impact
records previously in
bullet e) have been
incorporated in to
bullets c) and d).
4
Review of differences between Colour code: RED- Changes
in wording
ISO 9001:2000 and ISO 9001:2008 BLUE- Text deleted
VIOLET- New text
No colour code used where there is only change in word order

ISO 9001:2008 Clause Summary of change Impact of change

ISO 9001:2000 Clause

NOTE 1 Where the term
“documented procedure“
appears within this International
Standard, this means that the
procedure is established,
documented, implemented and
maintained.
4.2.3 Control of documents
f) to ensure that documents of
external origin are identified
and their distribution controlled,
and
NOTE 1 Where the term
“documented procedure“
appears within this International
Standard, this means that the
procedure is established,
documented, implemented and
maintained. A single document
may address the requirements
for one or more procedures. A
requirement for a documented
procedure may be covered by
more than one document.
4.2.3 Control of documents
f) to ensure that documents of
external origin determined by
the organization to be
necessary for the planning and
operation of the quality
management system are
identified and their distribution
controlled, and
Note 1 Additional text
has been added to
clarify a requirement
or requirements may
be covered in a single
document or many
documents
Clarification that the
external documents
needing control are
those needed for use
in the QMS
This gives more freedom for
how requirements are
documented.
In theory one procedure
can cover many clauses or
one requirement can be
spread over many
documents. Where the
organisation has spread
coverage over several
documents or combined
into one the organisation
will need to be able to show
how it has done this.
Gives the freedom to
exclude some external
documents where they do
not have any impact.

5
Review of differences between
in wording
ISO 9001:2000 and ISO 9001:2008
ISO 9001:2000 Clause
4.2.4 Control of records
Records shall be established
and maintained to provide
evidence of conformity to
requirements and of the
effective operation of the
quality management system.
A documented procedure shall
be established to define the
controls needed for the
identification, storage,
protection, retrieval,
retention time and
disposition of records.
5.5.2 Management
representative
Top management shall appoint
a member of management who,
irrespective of other
responsibilities, shall have
responsibility and authority that
includes
6.2 Human resources
6.2.1 General
ISO 9001:2008 Clause
4.2.4 Control of records
Records established to provide
evidence of conformity to
requirements and of the
effective operation of the
quality management system
shall be controlled.
The organization shall establish
a documented procedure to
define the controls needed for
the identification, storage,
protection, retrieval, retention
and disposition of records.
5.5.2 Management
representative
Top management shall appoint
a member of the organization’s
management who, irrespective
of other responsibilities, shall
have responsibility and
authority that includes.
6.2 Human resources
6.2.1 General
Colour code: RED- Changes
BLUE- Text deleted
VIOLET- New text
No colour code used where there is only change in word order
Summary of change Impact of change
Wording and has been No impact
modified to give a
change of emphasis
but the requirements
are the same.
No impact
Clarification that the Management
management representative needs to be
representative needs within the organisation.
to be a member of the
organisation’s own
management.
6
Review of differences between Colour code: RED- Changes
in wording
ISO 9001:2000 and ISO 9001:2008 BLUE- Text deleted
VIOLET- New text
No colour code used where there is only change in word order

ISO 9001:2008 Clause Summary of change Impact of change

ISO 9001:2000 Clause

Personnel performing work Personnel performing work ‘product quality’ No impact

affecting product quality shall
be competent on the basis of
appropriate education, training,
skills and experience.
6.2.2 Competence, awareness
and training
The organization shall
a) determine the necessary
competence for personnel
performing work affecting
product quality,
affecting conformity to product
requirements shall be
competent on the basis of
appropriate education, training,
skills and experience.
NOTE Conformity to product
requirements can be affected
directly or indirectly by
personnel performing any task
within the quality management
system.
6.2.2 Competence, training and
awareness
The organization shall
a) determine the necessary
competence for personnel
performing work affecting
conformity to product
requirements,
changed to ‘conformity
to product
requirements’.
New note added about This broadens the
impact on product requirement to analyse
conformity by competence and activities
personnel with direct throughout the company
or indirect involvement
Word order changed No impact
Wording ‘affecting No impact
product quality’
changed to ‘affecting
conformity to product
requirements’.

7
Review of differences between Colour code: RED- Changes
in wording
ISO 9001:2000 and ISO 9001:2008 BLUE- Text deleted
VIOLET- New text
No colour code used where there is only change in word order

ISO 9001:2008 Clause Summary of change Impact of change

ISO 9001:2000 Clause

b) provide training or take other
actions to satisfy these needs,
6.3 Infrastructure
c) supporting services (such as
transport or communication).
6.4 Work environment
7 Product realization
7.1 Planning of product
realization
b) where applicable, provide
training or take other actions to
achieve the necessary
competence,
6.3 Infrastructure
c) supporting services (such as
transport, communication or
information systems).
6.4 Work environment
NOTE The term "work
environment" relates to
conditions under which work is
performed including physical,
environmental and other factors
(such as noise, temperature,
humidity, lighting, or weather).
7 Product realization
7.1 Planning of product
realization
‘Where applicable’ Confirms the allowance for
added and training alternative methods than
should now ‘achieve training to establish
the necessary competence.
competence’ as
opposed to satisfy
these needs.
Now includes IT should have previously
information systems been audited in
infrastructure. This just
confirms it.
New note added to No impact, just clarification.
clarify what is meant
by the term ‘work
environment’
8
Review of differences between
in wording
ISO 9001:2000 and ISO 9001:2008
ISO 9001:2000 Clause
b) the need to establish
processes, documents, and
provide resources specific to
the product;
c) required verification,
validation, monitoring,
inspection and test activities
specific to the product and the
criteria for product acceptance;
7.2 Customer-related processes
7.2.1 Determination of
requirements related to
the product
c) statutory and regulatory
requirements related to the
product, and
Colour code: RED- Changes
BLUE- Text deleted
VIOLET- New text
No colour code used where there is only change in word order
ISO 9001:2008 Clause Summary of change Impact of change
b) the need to establish Slightly re-worded No impact
processes and documents, and
to provide resources specific to
the product;
c) required verification, The word This clarifies that the
validation, monitoring, ‘measurement’ has Processes in the QMS
measurement, inspection and been added. should include
test activities specific to the measurement
product and the criteria for requirements.
product acceptance; Measurement should
already have been
included. It may mean a
slight change in records
only.
7.2 Customer-related processes
7.2.1 Determination of
requirements related to the
product
c) statutory and regulatory The word ‘related’ has Confirms only applicable
requirements applicable to the been changed to regulations relating to a
product, and ‘applicable’ product need to be
determined.
9
Review of differences between
in wording
ISO 9001:2000 and ISO 9001:2008
ISO 9001:2000 Clause
d) any additional requirements
determined by the organization.
. NOTE Post delivery activities
7.3 Design and development
7.3.1 Design and development
planning
7.3.2 Design and development
inputs
ISO 9001:2008 Clause
d) any additional requirements
considered necessary by the
organization.
include, for example, actions
under warranty provisions,
contractual obligations such as
maintenance services, and
supplementary services such as
recycling or final disposal.
7.3 Design and development
7.3.1 Design and development
planning
NOTE Design and development
review, verification and
validation have distinct
purposes. They may be
conducted and recorded
separately or in any
combination as suitable for the
product and the organization.
7.3.2 Design and development
inputs
Colour code: RED- Changes
BLUE- Text deleted
VIOLET- New text
No colour code used where there is only change in word order
Summary of change Impact of change
The word ‘determined’ No impact.
has been changed to
‘considered necessary’
New note added to Post delivery was already
explain what ‘post included in clause a), this
delivery activities’ just clarifies what is meant.
might mean. Such as This may impact on some
warranty provisions. companies where not all
post delivery activities were
considered.
New note added to This just gives more
clarify that design freedom to recording
review, verification and design information.
validation have distinct
purposes but that they
may be carried out in
any suitable manner or
combination.
10
Review of differences between
in wording
ISO 9001:2000 and ISO 9001:2008
ISO 9001:2000 Clause
These inputs shall be reviewed
for adequacy. Requirements
shall be complete, unambiguous
and not in conflict with each
other.
7.3.3 Design and development
outputs
The outputs of design and
development shall be provided
in a form that enables
verification against the design
and development input and
shall be approved prior to
release.
7.5 Production and service
provision
7.5.1 Control of production and
service provision
Colour code: RED- Changes
BLUE- Text deleted
VIOLET- New text
No colour code used where there is only change in word order
ISO 9001:2008 Clause Summary of change Impact of change
The inputs shall be reviewed for ‘These’ inputs changed No impact
adequacy. Requirements shall to ‘the’ inputs
be complete, unambiguous and
not in conflict with each other.
7.3.3 Design and development
outputs
The outputs of design and ‘Provided in a form No impact
development shall be in a form that enables’ has been
suitable for verification against changed to ‘in a form
the design and development suitable for’.
input and shall be approved
prior to release.
NOTE Information for production New note added Preservation should be
and service provision can concerning the checked as design element
include details for the inclusion of for manuals.
preservation of product. preservation of product
7.5 Production and service
provision
7.5.1 Control of production and
service provision
11
Review of differences between
in wording
ISO 9001:2000 and ISO 9001:2008
ISO 9001:2000 Clause
d) the availability and use of
monitoring and measuring
devices,
f) the implementation of
release, delivery and post-
delivery activities.
7.5.2 Validation of processes for
production and service
provision
The organization shall validate
any processes for production
and service provision where the
resulting output cannot be
verified by subsequent
monitoring or measurement.
This includes any processes
where deficiencies become
apparent only after the product
is in use or the service has been
delivered.
7.5.3 Identification and
traceability
ISO 9001:2008 Clause
d) the availability and use of
monitoring and measuring
equipment,
f) the implementation of
product release, delivery and
post-delivery activities.
7.5.2 Validation of processes for
production and service
provision
The organization shall validate
any processes for production
and service provision where the
resulting output cannot be
verified by subsequent
monitoring or measurement
and, as a consequence,
deficiencies become apparent
only after the product is in use
or the service has been
delivered.
7.5.3 Identification and
traceability
Colour code: RED- Changes
BLUE- Text deleted
VIOLET- New text
No colour code used where there is only change in word order
Summary of change Impact of change
‘Measuring devices’ No impact
has been changed to
‘measuring equipment’
to expand the scope of
coverage as a device is
a type of equipment.
‘Release’ has been No impact
changed to ‘product
release’
Sentences have been No impact
combined. ‘This
includes any processes
where’ modified to
‘and as a consequence’
12
Review of differences between
in wording
ISO 9001:2000 and ISO 9001:2008
ISO 9001:2000 Clause
The organization shall identify
the product status with respect
to monitoring and measurement
requirements.
Where traceability is a
requirement, the organization
shall control and record the
unique identification of the
product (see 4.2.4).
7.5.4 Customer property
NOTE Customer property can
include intellectual property.
7.5.5 Preservation of product
ISO 9001:2008 Clause
The organization shall identify
the product status with respect
to monitoring and measurement
requirements throughout
product realization.
Where traceability is a
requirement, the organization
shall control the unique
identification of the product and
maintain records (see 4.2.4).
7.5.4 Customer property
NOTE Customer property can
include intellectual property and
personal data.
7.5.5 Preservation of product
Colour code: RED- Changes
BLUE- Text deleted
VIOLET- New text
No colour code used where there is only change in word order
Summary of change Impact of change
Clarification that Should have no impact but
inspection and test will need confirming
status must be
identified ‘throughout
product realization’
Rewording of records No impact
requirement under
traceability.
The words ‘and Personal data will need
personal data’ has checking as part of
been added to the note Customer Property.
about intellectual
property
13
Review of differences between
in wording
ISO 9001:2000 and ISO 9001:2008
ISO 9001:2000 Clause
The organization shall preserve
the conformity of product
during internal processing and
delivery to the intended
destination.
This preservation shall include
identification, handling,
packaging, storage and
protection.
Preservation shall also apply to
the constituent parts of a
product.
7.6 Control of monitoring and
measuring devices
The organization shall
determine the monitoring and
measurement to be undertaken
and the monitoring and
measuring devices needed to
provide evidence of conformity
of product to determined
requirements (see 7.2.1).
ISO 9001:2008 Clause
The organization shall preserve
the product during internal
processing and delivery to the
intended destination in order to
maintain conformity to
requirements.
As applicable, preservation shall
include identification, handling,
packaging, storage and
protection.
Preservation shall also apply to
the constituent parts of a
product.
7.6 Control of monitoring and
measuring equipment
The organization shall
determine the monitoring and
measurement to be undertaken
and the monitoring and
measuring equipment needed
to provide evidence of
conformity of product to
determined requirements.
Colour code: RED- Changes
BLUE- Text deleted
VIOLET- New text
No colour code used where there is only change in word order
Summary of change Impact of change
Rewording to clarify The ‘As Applicable’ may
the reasons for mean some records are
preservation. required to say why any
‘This’ has changed to methods of preservation
‘As applicable’ have been excluded or how
methods are ‘applicable’.
‘Measuring devices’ No impact
changed to ‘measuring
equipment’
‘Measuring devices’ No impact
changed to ‘measuring
equipment’ and the
reference to 7.2.1 has
been removed
14
Review of differences between Colour code: RED- Changes
in wording
ISO 9001:2000 and ISO 9001:2008 BLUE- Text deleted
VIOLET- New text
No colour code used where there is only change in word order

ISO 9001:2008 Clause Summary of change Impact of change

ISO 9001:2000 Clause

a) be calibrated or verified at a) be calibrated or verified, or Addition of ‘or both’ No impact

specified intervals, or prior to
use, against measurement
standards traceable to
international or national
measurement standards; where
no such standards exist, the
basis used for calibration or
verification shall be recorded;
c) be identified to enable the
calibration status to be
determined;
NOTE See ISO 10012-1 and ISO
10012-2 for guidance.
both, at specified intervals, or
prior to use, against
measurement standards
traceable to international or
national measurement
standards; where no such
standards exist, the basis used
for calibration or verification
shall be recorded (see 4.2.4);
c) have identification in order to
determine its calibration status;
NOTE 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.
after verified.
Reference (See 4.2.4)
added.
Reworded but no No impact
change in meaning.
Identification can
include reference to
calibration status on
equipment or
separately.
The original note has Where software is used for
been removed and calibration this should have
replaced by a new note some evidence that it can
to explain about the perform the function it is
use of computer being used for. This should
software (when it is already be the case.
used for monitoring
and measurement)
15
Review of differences between
in wording
ISO 9001:2000 and ISO 9001:2008
ISO 9001:2000 Clause
8.1 General
a) to demonstrate conformity of
the product,
8.2 Monitoring and
measurement
8.2.1 Customer satisfaction
8.2.2 Internal audit
ISO 9001:2008 Clause
8.1 General
a) to demonstrate conformity to
product requirements,
8.2 Monitoring and
measurement
8.2.1 Customer satisfaction
NOTE Monitoring customer
perception can include
obtaining input from sources
such as customer satisfaction
surveys, customer data on
delivered product quality, user
opinion surveys, lost business
analysis, compliments, warranty
claims and dealer reports.
8.2.2 Internal audit
Colour code: RED- Changes
BLUE- Text deleted
VIOLET- New text
No colour code used where there is only change in word order
Summary of change Impact of change
‘Of the product' has No impact
been changed to 'to
product requirements'
A new Note has been No impact.
added to give some
ideas on how customer
satisfaction can be
measured
16
Review of differences between
in wording
ISO 9001:2000 and ISO 9001:2008
ISO 9001:2000 Clause
An audit programme shall be
planned, taking into
consideration the status and
importance of the processes
and areas to be audited, as well
as the results of previous
audits.
The audit criteria, scope,
frequency and methods shall be
defined. Selection of auditors
and conduct of audits shall
ensure objectivity and
impartiality of the audit process.
Auditors shall not audit their
own work.
Colour code: RED- Changes
BLUE- Text deleted
VIOLET- New text
No colour code used where there is only change in word order
ISO 9001:2008 Clause Summary of change Impact of change
An audit programme shall be No impact.
planned, taking into
consideration the status and
importance of the processes
and areas to be audited, as well
as the results of previous
audits.
The audit criteria, scope,
frequency and methods shall be
defined. The selection of
auditors and conduct of audits
shall ensure objectivity and
impartiality of the audit process.
Auditors shall not audit their
own work.
A documented procedure shall Paragraph order has No impact.
be established to define the been changed.
responsibilities and Paragraph has also
requirements for planning and been reworded but
conducting audits, establishing requirement effectively
records and reporting results. the same.
17
Review of differences between Colour code: RED- Changes
in wording
ISO 9001:2000 and ISO 9001:2008 BLUE- Text deleted
VIOLET- New text
No colour code used where there is only change in word order

ISO 9001:2008 Clause Summary of change Impact of change

ISO 9001:2000 Clause

The responsibilities and
requirements for planning and
conducting audits, and for
reporting results and
maintaining records (see 4.2.4)
shall be defined in a
documented procedure.
The management responsible
for the area being audited shall
ensure that actions are taken
without undue delay to
eliminate detected
nonconformities and their
causes.
8.2.3 Monitoring and
measurement of
processes
Records of the audits and their
results shall be maintained (see
4.2.4).
The management responsible
for the area being audited shall
ensure that any necessary
corrections and corrective
actions are taken without undue
delay to eliminate detected
nonconformities and their
causes.
NOTE See ISO 19011 for
guidance.
8.2.3 Monitoring and
measurement of processes
The records No impact.
requirements has been
given a separate
paragraph.
‘Actions’ changed to Records for solving
make it clear that both problems found at audit will
Correction and now need to show both
Corrective Action are Correction and Corrective
required. Action
New note No impact guidance only.

18
Review of differences between
in wording
ISO 9001:2000 and ISO 9001:2008
ISO 9001:2000 Clause
The organization shall apply
suitable methods for monitoring
and, where applicable,
measurement of the quality
management system processes.
These methods shall
demonstrate the ability of the
processes to achieve planned
results. When planned results
are not achieved, correction and
corrective action shall be taken,
as appropriate, to ensure
conformity of the product.
ISO 9001:2008 Clause
The organization shall apply
suitable methods for monitoring of the product.’ has
and, where applicable,
measurement of the quality
management system processes.
These methods shall
demonstrate the ability of the
processes to achieve planned
results. When planned results
are not achieved, correction and
corrective action shall be taken,
as appropriate.
NOTE When determining
suitable methods, it is advisable
that the organization consider
the type and extent of
monitoring or measurement
appropriate to each of its
processes in relation to their
impact on the conformity to
product requirements and on
the effectiveness of the quality
management system.
Colour code: RED- Changes
BLUE- Text deleted
VIOLET- New text
No colour code used where there is only change in word order
Summary of change Impact of change
‘To ensure conformity Changed to make sure all
processes are considered
been removed. not just processes for
product.
New Note added to No impact note only.
explain that
consideration of the
type of monitoring and
measuring of
processes should
relate to the extent to
which they affect
quality and the QMS
19
Review of differences between Colour code: RED- Changes
in wording
ISO 9001:2000 and ISO 9001:2008 BLUE- Text deleted
VIOLET- New text
No colour code used where there is only change in word order

ISO 9001:2008 Clause Summary of change Impact of change

ISO 9001:2000 Clause

8.2.4 Monitoring and 8.2.4 Monitoring and

measurement of product measurement of product
Records shall indicate the Records shall indicate the Clarification of product No impact
person(s) authorizing release of person(s) authorizing release of release records.
product (see 4.2.4). product for delivery to the
customer (see 4.2.4).
Product release and service The release of product and ‘Product release and No impact
delivery shall not proceed until delivery of service to the service delivery’
the planned arrangements (see customer shall not proceed until changed to ‘The
7.1) have been satisfactorily the planned arrangements (see release of product and
completed, unless otherwise 7.1) have been satisfactorily delivery of service to
approved by a relevant completed, unless otherwise the customer’. This
authority and, where applicable, approved by a relevant clarifies final release.
by the customer. authority and, where applicable,
by the customer.
8.3 Control of nonconforming 8.3 Control of nonconforming
product product
The controls and related A documented procedure shall The requirement for a No impact
responsibilities and authorities be established to define the documented procedure
for dealing with nonconforming controls and related has been reworded but
product shall be defined in a responsibilities and authorities the meaning remains
documented procedure. for dealing with nonconforming unchanged
product.

20
Review of differences between Colour code: RED- Changes
in wording
ISO 9001:2000 and ISO 9001:2008 BLUE- Text deleted
VIOLET- New text
No colour code used where there is only change in word order

ISO 9001:2008 Clause Summary of change Impact of change

ISO 9001:2000 Clause

The organization shall deal with
nonconforming product by one
or more of the following ways:
When nonconforming product is
detected after delivery or use
has started, the organization
shall take action appropriate to
the effects, or potential effects,
of the nonconformity.
8.4 Analysis of data
Where applicable, the
organization shall deal with
nonconforming product by one
or more of the following ways:
d) by taking action appropriate
to the effects, or potential
effects, of the nonconformity
when nonconforming product is
detected after delivery or use
has started.
8.4 Analysis of data
The phrase ‘where
applicable’ has been
added.
Paragraph 4 has been
change to d) but
effectively no change.
Where one of the
prescribed methods has not
been followed reasons why
it was ‘Not Applicable’ will
need to be recorded. Other
actions will still need to
have been taken.
No impact

21
Review of differences between Colour code: RED- Changes
in wording
ISO 9001:2000 and ISO 9001:2008 BLUE- Text deleted
VIOLET- New text
No colour code used where there is only change in word order

ISO 9001:2008 Clause Summary of change Impact of change

ISO 9001:2000 Clause

The analysis of data shall
provide information relating to
b) conformity to product
requirements (see 7.2.1),
c) characteristics and trends of
processes and products
including opportunities for
preventive action, and
d) suppliers.
8.5.2 Corrective action
The organization shall take
action to eliminate the cause of
nonconformities in order to
prevent recurrence.
The analysis of data shall
provide information relating to
b) conformity to product
requirements (see 8.2.4),
c) characteristics and trends of
processes and products,
including opportunities for
preventive action (see 8.2.3 and
8.2.4), and
d) suppliers (see 7.4).
8.5.2 Corrective action
The organization shall take
action to eliminate the causes
of nonconformities in order to
prevent recurrence.
b) conformity to No impact.
product requirements
is now pointed to the
Clause 8.2.4
monitoring and
measurement of
product rather than
7.2.1.
c) A reference to the
monitoring and
measuring clauses has
been added.
d) A reference to the
Purchasing clause has
been added.
‘cause’ becomes Implies that corrective
‘causes’ actions should look for
causes not just one cause.
If proper analysis is done
this will not have any
impact.

22
Review of differences between Colour code: RED- Changes
in wording
ISO 9001:2000 and ISO 9001:2008 BLUE- Text deleted
VIOLET- New text
No colour code used where there is only change in word order

ISO 9001:2008 Clause Summary of change Impact of change

ISO 9001:2000 Clause

f) reviewing corrective action
taken.
8.5.3 Preventive action
e) reviewing preventive action
taken.
f) reviewing the effectiveness of
the corrective action taken.
8.5.3 Preventive action
e) reviewing the effectiveness
of the preventive action taken
The words ‘the Review of actions should
effectiveness’ have look at their effectiveness
been added to
emphasise the purpose
of the review.
The words ‘the Review of actions should
effectiveness’ have look at their effectiveness
been added to
emphasise the purpose
of the review.

23