CLAUSE

CHANGES

0.1 Para. 3

Text added to include statutory requirements as well as customer and regulatory and clarifies that these requirements are applicable to the product.

0.2 Para. 3

Text added to focus on importance of processes producing the desired outcome.

0.3 Para. 2

Text added to include statutory and regulatory requirements.

1.1

Text added to include statutory requirements.
Note 1 expanded to include purchased product and output from product realization processes.
Note 2 added indicating that statutory and regulatory requirements may be expressed as legal requirements.

1.2

Text added to include statutory requirements.

2

Reference to ISO 9000 now indicates 2005 version.

3

Definition of supplier, organization and customer has been deleted.

4.1

a. – The word ‘determine’ has replaced ‘identify.’
e. - The phrase ‘where applicable’ was added after ‘measure.’
Note. 1 - The wording ‘analysis and improvement’ was added.
Note 2 - Added to define outsourced process.
Note 3 - Added to define type and nature of control applied to outsourced processes.

4.2.1

Revised to clarify that QMS documentation includes records.
Note 1 expanded to clarify that one document may include the requirements of one or more procedures and the requirements of one procedure may be covered by more than one document.

4.2.3

Text added to clarify that external documents are those needed for use in the QMS.

5.5.2

Clarifies that management representative must be a member of the organization’s own management.

6.2.1

Note added to clarify that conformity to product requirements may be affected directly or indirectly by personnel performing any task within the QMS.

6.2.2

Change in title from ‘Competence, awareness and training’ to ‘Competence, training and awareness.’
a. – Wording change from ‘affecting product quality’ to ‘conformity to product requirements.’
b. - The phrase ‘where applicable’ was added.
c. - Revised to require assurance that the necessary competence has been achieved, rather than evaluating the effectiveness of training.

6.3

c. - Revised to include information systems.

6.4

Note added to clarify definition of work environment.

7.1

c. – The word ‘measurement’ was added.

7.2.1

a. – Slightly reworded
c. - The word ‘related’ was replaced with ‘applicable.’
d. – The word ‘determined’ was replaced with ‘considered necessary.’
Note added to clarify that post-delivery activities include actions under warranty provisions, contractual obligations such as maintenance services, and supplementary services such as recycling or final disposal.

7.3.1

Note added to clarify that design and development review, verification and validation have distinct purposes and may be performed separately or in any combination as suitable for the product and the organization.

7.3.2

In last paragraph, ‘these’ changed to ‘the.’

7.3.3

First paragraph – The word ‘provided’ was omitted and the phrase ‘that enables’ was replaced by ‘suitable for.’
Note added to clarify that production and service provision may include details for the preservation of product.

7.5.3

Second paragraph – The phrase ‘throughout product realization’ was added.
Last paragraph – The phrase ‘and maintain records’ was added.

7.5.4

Note – The phrase ‘and personal data’ was added as part of customer property.

7.5.5

Phrase ‘conformity of’ was changed to ‘in order to maintain conformity to requirements’ and ‘where appropriate’ was changed to ‘as applicable.’

7.6

Title of clause changed from ‘devices’ to ‘equipment.’
The reference to 7.2.1 was removed.

1. – The phrase ‘or both’ was added.

3. – The phrase ‘be identified to enable’ was replaced with ‘have identification.’

Note referencing ISO 10012-1 and ISO 10012-2 was deleted and replaced with a note related to the confirmation of computer software used as monitoring and measuring equipment.

8.1

a. – The word ‘requirements’ was added.

8.2.1

Note added to provide examples of how customer satisfaction data can be measured.

8.2.2

Editorial changes to clause to clarify requirements.

• Reworded requirement for documented procedure
• Clarified record requirements by adding ‘records of the audits and their results’
• Clarified that management responsible for the area being audited shall ensure that ‘any necessary corrections and corrective actions are taken.’
• Note – Reference to ISO 10011-1, 10011-2 and 10011-3 changed to ISO 19011.

8.2.3

The phrase ‘to ensure conformity of the product’ was deleted.
Note added to clarify that the organization should consider the type of monitoring and measuring of processes and the extent to which they effect conformity to product requirements and the effectiveness of the QMS.

8.2.4

The phrase ‘for delivery to the customer’ was added to clarify that the release of the product relates to the delivery to the customer.

8.3

Reworded requirement for documented procedure.
Second paragraph – The phrase ‘where practicable’ was added.