Clause

Clause Title

Change 2000 – 2008

0.1

General

Additional guidance added to clarify the range of factors that will affect the design and implementation of the quality management system (e.g. its business environment, risks)

Additional note included to express the ability of the standard to be used to help organisations meet statutory as well as customer requirements

0.2

Process approach

Wording change – organisations must “determine” (rather than “identify”) and manage numerous linked activities

Wording change to emphasise that processes must be capable of achieving desired outputs

0.3

Relationship with ISO 9004

Note added to clarify that at the time of publication ISO 9004 is under review

0.4

Compatibility with other management systems

Note added to clarify the influence of ISO 14001:2004 on the development of ISO 9001:2008

1.1

Scope

Wording change to clarify that “product can also mean “intermediate product” and a note to explain that statutory and regulatory requirements may
be expressed as legal requirements

Note to clarify that the word “product” applies to any intended output

4.1

General requirements

Wording change to require organisations to “determine” rather than “identify” processes needed for the QMS

Notes and explanations included to clarify the requirements regarding “outsourcing” and its relationship with “purchasing”

4.2.1

General documentation requirements

Notes will be included to emphasise that “documentation” can also include “records” and that mandatory procedures may be in the form of combined documents, or that requirements may be covered by more than one document

4.2.3

Document control

Note to clarify that only external documents affecting the QMS need to be controlled

5.5.2

Management representative

Clarification that the MR must be a member of the organisation’s OWN management

6.2.1

Human resources

Clarification that competence requirements apply to any personnel whose work affects conformity of product rather than “quality”

6.3

Infrastructure

Clarifies that this includes Information Systems

6.4

Environment

Clarification of circumstances that are covered by this clause (e.g. noise, temperature, humidity)

7.2.1

Customer related processes

Clarification of what may be covered by “post delivery activities”

7.3.1

Design & development planning

Clarification that review, validation and verification all have distinct purposes but may be conducted and recorded either separately or in a combined way if appropriate

7.3.3

Design & development outputs

Clarification that product preservation requirements must be considered

7.5.4

Customer property

Clarification that intellectual property and personal data are covered by the clause

7.6

Control of monitoring & measuring devices

Retitled. Replace “devices” with “equipment”. Explanation of its applicability to software

8.2.1

Customer satisfaction

Note offers examples of how perception data may be captured

.2.3

Monitoring and measurement of processes

Clarification that identifies that consideration be given to product conformity and QMS effectiveness