Configuration Management - Is Configuration Management a requirement of ISO 9001

[Jim Wynne]

I don't think one of my questions has yet been appropriately answered and I expect other experts to provide a reasonable answer to my queries:

"What does 'notes' (in these two particular instances) clarify ?" and
What does the standard mean when it says

"............ the intended application would typically include its verification and configuration management to maintain its suitability for use."

First, in answer to the original question, ISO 9001 does not specifically include a requirement for "configuration management." This does not mean (herein lies the confusion, I think) that no form of configuration management is required. Control of documents (for example) is required, and it's a form of configuration management. The folks here who say that "configuration management" isn't required are correct, but only in a narrow sense.

As to your question about notes in the standard, it's best to think of them as reminders--an attempt to highlight certain situations where there might be requirements. There will be instances where the "guidance" in notes will be a requirement, but they don't apply universally, and thus are not described as requirements in the sense that having a documented procedure for corrective action is a requirement (for everyone).

 

[samsung]

First, in answer to the original question, ISO 9001 does not specifically include a requirement for "configuration management." This does not mean (herein lies the confusion, I think) that no form of configuration management is required. Control of documents (for example) is required, and it's a form of configuration management. The folks here who say that "configuration management" isn't required are correct, but only in a narrow sense.

As to your question about notes in the standard, it's best to think of them as reminders--an attempt to highlight certain situations where there might be requirements. There will be instances where the "guidance" in notes will be a requirement, but they don't apply universally, and thus are not described as requirements in the sense that having a documented procedure for corrective action is a requirement (for everyone).

Great answer indeed. This is exactly the way I was expecting someone to explain to me why it is (or is not) a requirement under the given circumstances.

Thanks for your reasonably convincing thoughts.