Differences between ISO 9001:2000 and ISO 9001:2008

Introduction

Following the revision of ISO 9001:2000 to the 2008 edition, Excel Partnership has published this
document providing a summary of the changes and their likely impact to organizations. The changes
do not represent any modification to the intent of ISO 9001, mainly just rewording to update the
standard in the light of other reference documents and clarification of wording. The most significant
changes are in the addition of clarification notes which may be of benefit to organizations looking for
ideas on how to interpret the requirements. In any case, the fact that the standard is being updated
represents an opportunity for organizations to revisit some of the requirements and how these are
interpreted and implemented within an organization.

Summary of Changes and their Impacts

Note: The reference numbers refer to the clause numbers of ISO 9001:2008.
Section Changes Impact of Change
Section 0.1: The introduction makes mention of the influence None
General of an organization’s business environment,
changes and associated risks.

The standard confirms that assessment of an

organization is in the context of requirements
which relate to the “product”. These include
statutory requirements
Section 0.2 The standard identifies that processes are None
Relationship managed to produce desired outcomes as part
with ISO 9004 of the “process approach

Section 0.3 Minor rewording only. Mention is made in the None

Relationship use of ISO 9001 to meet applicable statutory
with ISO 9004 and regulatory requirements and the role of ISO
9001 guidance particularly in managing for the
sustainable success of the organization
Section 0.4 Reference to ISO 14001 update to the 2004 None
Compatibility edition
with other
management
systems

Section 1.1 - Additional guidance has been added to ‘Note 1’ In so far as ‘notes’ are only
Scope - relating to the term ‘product’ This states that the provided as guidance, there is no
General ‘product’ not only applies to the product actual change to the standard
intended for, or required by, a customer, but other than to clarify the term
also that intended for, or required by the product ‘product’. It has always been the
realization process and any intended output practice of training and
resulting from such processes, including certification bodies to use the
purchasing. An additional note has been added term ‘product’ in this broader
stating that ‘Statutory and regulatory sense, and so no practical
requirements may be expressed as legal change to interpretation is likely
requirements to occur

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Section 2 - Change to the wording related to ‘referenced None
Normative documents’ which are ‘indispensable for the
references operation of this document’. The wording is now
simplified and reference to ISO 9000 updated to
the 2005 version
Section 3 - The description of the terms relating to None
Terms and organization, supplier, subcontractor etc referred
definitions to in the 2000 edition have been removed

4.1 Quality 4.1e adds the words “where applicable” to This clarifies what was
Management monitoring and measuring previously understood in that
System measurements are required
where they add value

The paragraph on outsourcing has some text No change to the intent of the
changes relating to the control of outsourced standard, just to affirm that
processes. Instead of stating ‘control of such there must be a defined
outsourced processes shall be identified’ the methodology for control of
wording has changed to ‘the type and extent of outsourced processes
control to be applied to these outsourced described in the organization’s
processes shall be defined’ within the quality management system if such
management system. processes exist. If this has not
been considered by
The words ‘analysis and improvement’ have been organizations using the
added to Note 1, to include these aspects as standard then this needs to be
processes, and additional notes added to explain considered. Notes give
the term ‘outsourced processes and examples of additional guidance on the
‘control’ that may be applied to outsourced subject
processes together with some guidance on
considerations that outsourced processes should
ensure conformity to customer, statutory and legal
requirements
4.2.1 Some minor wording changes, and the words None, unless the organization
Documentation ‘records required by this international standard’ has elected to document each
requirements - have been deleted. This is, however, now requirement for a procedure in
General covered in section 4.2d. a separate document

Addition has been made to ‘Note 1’ to state that a

single document may include the requirements for
one or more procedures. For example the subject
of ‘document control’ and ‘records’ could be
covered in a single procedure. There has never
been a requirement to state that this was not
permissible, therefore there is no actual change to
the intent of the standard
4.2.3 – Control Further clarification has been added to the subject No change to the intent of the
of documents of control of ‘external documents’ in that the standard which has always
organization is required to determine which been to control relevant
documents are necessary for the planning and external documentation.
operation of the quality management system.

4.2.4 – Control Minor rewording only None

of records

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5.5.2 The standard now requires that the management This change does impact
Management representative must be a member of the organizations who engage an
representative organization’s management (as opposed to an external consultant or adviser
external individual). to act in the role of
management representative
which is an approach often
adopted by smaller companies.
In practice, however, the main
part of this role (for example
internal audits and follow-up,
preparation of reviews,
changes to the management
system could still be performed
by an external party as long as
a member of the organization’s
management team was
charged with the responsibility
and authority for ensuring that
the work was done in an
effective manner.

6.2.1 Human A note has been added stating that ‘conformity to No change to original intent of
Resources - product requirements may be affected directly or the standard.
General indirectly by personnel performing any task within
the quality management system’ and thus
personnel involved in such activities are required
to be competent on the basis of appropriate
education, training, skills and experience
6.2.2 The organization is required to ‘determine the No change to intent of the
Competence, necessary competence for personnel performing standard, but more emphasis
awareness and work affecting ‘conformity to product on competence and the
training requirements’ as opposed to ‘product quality’. confirmation that this has been
Taking Crosby’s definition of quality as achieved.
‘conformance to requirements’ these may be
understood to say the same thing.

The standard has been reworded somewhat in

this section adding ‘where applicable’ to the
provision of training, however with emphasis on
the achievement of competence and ‘to ensure
that the necessary competence has been
achieved’
6.3 An additional example of a supporting service is No change to intent but this
Infrastructure provided (information systems now reflects current thinking
that, in many organizations, the
IT infrastructure is a critical
component of the business
system and therefore needs to
be maintained and adequately
resourced

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6.4 Work An additional note has been added to clarify the The note does not affect the
environment term ‘work environment’ as ‘conditions under original intent of the standard
which work is performed including physical, as the requirement is still
environmental and other factors (such as noise, focused on conformity to
temperature, humidity, lighting, or weather) product requirements.
However, organizations should
be aware that other quality
systems standards include in
this section safety of
employees and ISO 9004
mentions ergonomics so a
wider view of the impact on
more than the product could be
taken.

7.1 Planning of The word ‘measurement’ has been added to the No change to the original intent
product requirement that ‘in planning product realization, of the standard.
realization the organization shall determine (as appropriate),
the required, verification, validation, monitoring,
measurement, inspection and test activities
specific to the product and the criteria for product
acceptance
7.2.1 Minor clarification of wording from ‘requirements Control of ‘post-delivery’
Determination determined by the organization’ to ‘requirements activities was required in the
of considered necessary by the organization’. previous version of the
requirements standard, so no change has
related to the
product
A note has been added to provide explanation as been made to the intent. It
to what is considered ‘post delivery’ (i.e. activities might, however, be prudent for
including, for example, actions under warranty organizations to check that the
provisions, contractual obligations such as relevant examples provided in
maintenance services, and supplementary the note are covered within the
services such as recycling or final disposal). management system

7.3.1 Design A note has been added stating that ‘design and As the previous version of the
and development review, verification and validation standard did not specify how
development have distinct purposes. They may be conducted review, verification and
planning and recorded separately or in any combination as validation activities were to be
suitable for the product and the organization’ conducted and recorded, there
is no change to the intent of the
standard
7.3.3 Design Minor rewording; from ‘form that enables No change to the intent of the
and verification’ to ‘form suitable for verification’. original standard, however
development Additional note added stating ‘information for organizations obviously should
outputs production and service provision may include ensure that the design output
details for the preservation of product’. does in fact provide for the
This amplifies the requirement that the design ‘safe and proper use’ of the
output is required to ‘specify the characteristics of product
the product that are essential for its safe and
proper use’.

7.5.1 The previous standard referred to ‘measuring None

Production and devices’ which have now been renamed
service ‘measuring equipment’
provision

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7.5.2 Validation Clarification has been made to the requirement No change to original intent of
of processes relating to processes which can not be verified by the standard
for production subsequent monitoring or measurement. Adding
and service the words ‘and as a consequence, deficiencies
provision
become apparent only after the’ (product is in use
or the service has been delivered).

7.5.3 Product status is required to be maintained If the organization is currently

Identification throughout the product realization process. not maintaining control of
and traceability The standard also requires maintenance of product status throughout the
records of traceability product realization process (for
example by bar codes, stickers,
routing cards, records etc
throughout all stages of
production, i.e. from receipt of
goods through manufacture to
dispatch) then action will be
required to be taken to
establish the necessary
controls. However, the 2000
version of the standard
required something similar to
this in the first paragraph of this
clause.
Similarly, if traceability is a
requirement (for example to
trace material back to its
source or test certification) then
such records will be required to
be maintained. However it was
a requirement to control and
record which has now been
modified to control....and
maintain records.

7.5.4 Customer Minor rewording has taken place to the The note states that customer
Property requirement (‘records maintained’ to ‘maintain property can include intellectual
records’). property and personal data.
The organization thus should
A note has been added to include ‘personal data’ ensure that such data is
as customer property properly controlled and
protected as per the
requirements of clause 7.5.4.
This obviously has
repercussions in terms of the
security of computer data
stored on memory
sticks/computer hard drives etc.
and has linkages to the Data
Protection Act with the concept
of “personal data”.

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7.5.5 Emphasis is made in the requirement that No change to the intent of the
Preservation of conformity to requirements is required to be standard, however
product maintained. The words ‘as applicable’ have been organizations are required to
added to the requirements for preservation in ensure that the product
order to suit different organizations’ requirements continues to meet any
applicable requirements
throughout storage and delivery
to the intended destination.
This would obviously include
the use of appropriate storage
conditions, suitable packaging
etc
7.6 Control of The word ‘device’ is now replaced by the word The significance of the word
monitoring and ‘equipment’. change to equipment only
measuring makes the standard easier to
equipment Paragraph c) has also been reworded to make understand. There is no reason
clearer in that equipment must, where necessary, why an organization should
‘have identification in order to determine its need to change its terminology
calibration status’. to reflect this change as long as
the requirements are fulfilled.
The standard also adds a note to the existing Measuring equipment is
requirement relating to the control of computer required to be identified so that
software in terms of confirmation of its suitability calibration and maintenance
for use. records can be retrieved and so
that the need for calibration and
Reference is no longer made to ISO 10012-1/2 the equipment’s calibration
which gave guidance on calibration systems. status can be easily
determined.
Consideration should be given
to confirmation of suitability of
computer software relating to
monitoring and measurement in
terms of verification (i.e.
checking) and configuration
management (i.e. change
control) of software
8.2.1 Customer An additional note has been added giving some The guidance note states that
satisfaction guidance on obtaining data on customer data on customer satisfaction
perception can be gained from surveys,
customer data on delivered
product, user opinion, lost
business analysis,
compliments, warranty claims
and dealer reports . The
organization can, of course,
determine its own methods for
gathering such data. The issue
of the new standard may well
provide an opportunity for
organizations who already have
ISO 9001 certification to revisit
the requirement on customer
satisfaction to ensure that their
systems are effective in
providing meaningful data

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8.2.2 Internal Some rewording of the standard has taken place There is no change to the intent
Audit concerning documented procedures. However the of the requirement. However
intent remains the same. organizations need to ensure
that they do keep records
The standard now explicitly requires the which demonstrate that audits
maintenance of records of audits and their results. have been performed and the
Minor rewording has also taken place adding results of such audits. It would
‘necessary corrections and corrective’ actions are be interesting if any
taken. organizations had managed to
become certified without having
The standard now refers to ISO 19011 in terms of a record of audits!
guidance on auditing (ISO 19011 supersedes ISO
10011 referred to in the previous version).

8.2.3 Monitoring Minor editing has been undertaken to remove the The note gives some
and words ‘to ensure conformity of the product’. clarification on the
measurement of However the intent of the clause remains the establishment of
processes same. measurement/monitoring
systems which are appropriate
An additional note has been added relating to to the needs of the
consideration of the type and extent of monitoring organization. This may be a
and measurement and its impact on the product useful prompt for organizations
and system who are already ISO 9001
compliant to revisit such
systems to ensure that the
monitoring and measurement
systems are appropriate to
meet needs
8.2.4 Monitoring The standard now specifies that ‘records shall None
and indicate the person(s) authorizing release of
measurement of product for delivery to the customer’. This
product emphasises the general theme of ‘customer focus’
throughout the standard.

Minor rewording has also taken place concerning

product release to ‘the release of product and
delivery of service to the customer’. However the
intent remains the same.

8.3 The wording of the requirements relating to Organizations may wish to

Nonconforming documented procedures has changed slightly, review whether their existing
product however the intent remains the same. systems allow any flexibility
Flexibility has been introduced concerning the concerning the disposition of
disposition of nonconforming product by the nonconforming product as a
addition of the words ‘where practicable’. result of the introduction of the
The requirements have also been restructured words ‘where practicable’
slightly concerning the detection of nonconforming
product after delivery or use has started, however
the requirements remain the same
8.5.2 The clause has been strengthened slightly by There is no change to the
Corrective adding the words ‘effectiveness’ to the review of original intent of the standard
Action the corrective action taken. The intent was, of providing of course the
course, always that the review activity would organization does review the
consider the effectiveness of the action taken. effectiveness of corrective
actions taken.

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8.5.3 As with clause 8.5.2, the wording has been There is no change to the
Preventive strengthened slightly by adding the words original intent of the standard
Action ‘effectiveness’ to the review of the preventive providing of course the
action taken. The intent was, of course, always organization does review the
that the review activity would consider the effectiveness of preventive
effectiveness of the action taken. actions taken.

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