Additional guidance has been 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)

An additional note has also been included to express the ability of the standard to be used to help organisations meet statutory as well as customer requirements

A wording change has been introduced  – organisations must “determine” (rather than “identify”) and manage numerous linked activities

A second wording change emphasises that processes must be capable of achieving desired outputs

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

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

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

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”

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

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

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

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

Clarifies that this includes Information Systems

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

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

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

Clarification that product preservation requirements must be considered

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

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

Note offers examples of how perception data may be captured

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