Section

Ref

Change

0.1

Para 1

The influences on the design and implementation of an organization’s quality management system are redefined and listed including environmental considerations and risk.

Para 4

Statement of where and who can use the standard now includes statutory requirements as well as customer and regulatory and clarifies that these requirements are restricted to those applicable to the product

0.2

Para  2&3

Minor clarifications and process definitions

0.3

Changed description of the relationship between ISO9001 and ISO9004.  Continue to complement each other.

Notes

New note stating ISO9004 under revision

0.4

Para 1

A comment has been added that the development of ISO 9001:2008 made due consideration to ISO 14001:2004, and reference to Annex A for correspondence between the standards.

1.1

Bullets a) & b)

Again, statutory requirements have been added (as in 0.1)

Notes

Note 1 has been amended to include comments regarding purchased product as well as product from realization processes.
Note 2 has been added explaining that statutory and regulatory requirements may be expressed as legal requirements

1.2

Para 3

Again, statutory requirements have been added (as in 0.1)

2

Para 1

Amended to emphasize use of referenced documents

Para 2

The reference to ISO 9000 now states the fact that is at version 2005

3

Paras 2&3

The explanation of who the ‘customer’, ‘organisation’ and ‘supplier’ are, has been removed

4.1

Bullets

a) The word ‘identify’ has been replaced with ‘determine’
e) Where applicable has been added to measure

Para 4

«

The statement regarding outsourced processes has been slightly re-worded and emphasizes that the outsourced controls shall be defined in the quality management system.
This is a new ‘shall’

Notes

Note 1 ‘analysis and improvement ‘ added to list of process inclusions
Note 2 has been added giving a definition of an outsourced process
Note 3 expands on the type of control that may be applied to outsourced processes in order to ensure control over them including a link to clause 7.4 Purchasing

4.2.1

c) & d)

The wording has been slightly remodelled but the intent stays the same.
The requirements for records previously in bullet e) have been incorporated in to bullets c) and d).

Notes

Note 1 has been added to clarify that a single document may include the requirements for one or more procedures. A requirement for a documented procedure may be covered by more than one document.

4.2.3

f)

Clarification that the external documents referred to are those needed for use in the QAMS

4.2.4

Restructured to three paragraphs but contain the same requirements.
The ‘shall’ requirement for control emphasized.

5.5.2

Para 1

The requirement that the management representative needs to be a member of the organization’s management has been added

Notes

Word change from ‘liaison’ to ‘liaising’.

6.2.1

Para 1

Change in wording to replace ‘product quality’ with ‘conformity to product requirements’.

Notes

New note added concerning the effects of direct or indirect personnel on conformity

6.2.2

Title

Change in title to ‘Competence, training and awareness’ but keeps same words (change in their order)

a)

Where the current version mentions ‘… affecting product quality’, it now states ‘… affecting conformity to product requirements’.

b)

b) now states that ‘where applicable’ training needs to be provided ‘to achieve the necessary competence’

6.3

c)

now includes information systems

6.4

Notes

New note added to clarify what work environment includes and gives some examples such as noise, temperature, humidity

7.1

b)

Slightly re-worded

c)

The word ‘measurement’ has been added to list

7.2.1

c)

The word ‘related’ has changed to ‘applicable’

d)

The word ‘determined’ has changed to ‘considered necessary’

Notes

New note added to explain what the phrase ‘post delivery activities’ may include i.e. warranty provisions, etc

7.3.1

Notes

New note added to explain that design review, verification and validation are separate activities though they may be performed separately or in any combination e.g. verification and validation may be performed together

7.3.2

Para 2

‘These’ inputs becomes ‘the’ inputs (last paragraph)

7.3.3

Para 1

The words ‘provided in a form that enables’ have been replaced by ‘in a form suitable for’.

b)

the word ‘for’ (service provision) has been removed

Notes

New note added regarding the inclusion of preservation of product

7.5.1

d)

‘measuring devices’ has been replaced by ‘measuring equipment’

f)

‘release’ has been replaced by ‘product release’.

7.5.2

Para 1

Sentences combined with the removal of ‘ This includes any processes where’ and the inclusion of’ and, as a consequence of’

7.5.3

Para 2

An added requirement to clarify that inspection and test status must be identified ‘throughout product realization’

Para 3

Slight re-wording of record requirement under traceability

7.5.4

Para 1

Re-wording of the requirement to inform the customer if there is a problem and keep records

Notes

The phrase ‘and personal data’ has been added to the note about intellectual property

7.5.5

Para 1

Re-wording and changed placement of ‘conformity of’ to ‘in order to maintain conformity to requirements’
‘This’ has changed to ‘As applicable’ (sentence 2)

7.6

Title

Title change from ‘measuring devices’ to ‘measuring equipment’

Para 1

Change from ‘measuring devices’ to ‘measuring equipment’ and the reference to 7.2.1 has been removed

a)

Addition of ‘or both’ after verified

c)

Complete reword but no change.

Para 4&5

Last sentence of paragraph 4 made in to separate paragraph without change.

Notes

Original note removed and replaced by note to explain about the verification and configuration management of computer software (where it is used to monitor and measure

8.1

a)

‘of the product’ replaced with ‘to product requirements’

8.2.1

Notes

A Note has been added to provide some ideas as to how customer satisfaction can be measured

8.2.2

Para 2

‘This’ added for the selection of auditors.

Para 3

The requirement for a documented procedure has been re-worded but remains unchanged

Para 4

New paragraph. Taken the records requirements for paragraph 3 and given separate emphasis.

Para 5

A requirement for management responsible for the area audited to ensure that ‘necessary corrections and corrective actions’ has been added

Notes

Note that makes reference to ISO 19011

8.2.3

Para 1

The phrase ‘to ensure conformity of the product’ has been removed

Notes

A Note has been added to explain that the organization should consider the type of monitoring and measuring of processes and the extent to which they affect quality and the QAMS

8.2.4

Para 1

The requirement to ‘maintain evidence of conformity with acceptance criteria’ has moved but is still a requirement

Paras 2&3

Evidence of conformity moved to paragraph 1.
Clarification of the fact that product release/service delivery is ‘to the customer’ has been added

8.3

Para 1

The requirement for a documented procedure has been re-worded but remains unchanged

Para 2

The phrase ‘where applicable’ has been added to the methods for dealing with nonconforming product

d)

New bullet, was paragraph 4 concerning action to be taken after delivery has been made.

Paras 3&4

Content unchanged but swapped.

8.4

b)

Change of reference to 8.2.4

c)

Addition of reference to 8.2.3 & 8.2.4

d)

Addition of reference to 7.4

8.5.2

Para 1

‘cause’ becomes ‘causes’

f)

Insertion of ‘the effectiveness of the’ to Corrective Action

8.5.3

e)

Insertion of ‘the effectiveness of the’ to Preventive Action

Annexes

All

Updated to show ISO9001:2008 & ISO14001:2004