Configuration Management - Is Configuration Management a requirement of ISO 9001

[samsung]

Re: Configuration Management

As you pointed out There is no associated requirement for configuration management in ISO 9001. You are trying to make a note a requirement, by inferring that configuration management is a requirement, which it isn't. AS9100, for example, has a CLEAR requirement for a configuration management process to exist.

If it's not a requirement, as you maintain, can you clarify then what do these 'Notes' clarify or guide to with no reference to any of the associated requirement ?

How those particular segments would otherwise satisfy the requirements of 7.53 & 7.6 ?

 

[AndyN]

Re: Configuration Management

If it's not a requirement, as you maintain, can you clarify then what do these 'Notes' clarify or guide to with no reference to any of the associated requirement ?

How those particular segments would otherwise satisfy the requirements of 7.53 & 7.6 ?

It's simple. If it were a requirement, it would be defined under the main topic 7.5 etc. Since ISO 9001 is written as a 'one size fits all' set of requirements, the TC 176 folks saw fit to guide users in the application of the requirement, by describing situations such as configuration management, as a method to meet the requirement.

Unless there's a misunderstanding of the use of language here, which is often true, then there should be no discussion.

 

[Sidney Vianna]

Re: Configuration Management

If it's not a requirement, as you maintain, can you clarify then what do these 'Notes' clarify or guide to with no reference to any of the associated requirement ?

The first note obviously clarifies issues related to product identification and traceability. It states:

NOTE In some industry sectors, configuration management is a means by which identification and traceability are maintained.

Pay attention to the emphasized text. The second note reads

NOTE Confirmation of the ability of computer software to satisfy the intended application would typically include its verification and configuration management to maintain its suitability for use.

How many companies out there don't even use software to test their products? Would you expect they to claim and justify an exclusion to configuration management in their manual?

With your line of thought, you would think that a Management Representative would be the only possible liaison between the organization and their certification body, even though the note under 5.5.2 states that CAN be of one of his/her responsibilities.

 

[samsung]

Re: Configuration Management

With your line of thought, you would think that a Management Representative would be the only possible liaison between the organization and their certification body, even though the note under 5.5.2 states that CAN be of one of his/her responsibilities.

What about this example of 'Note' ?

The organization shall determine and manage the work environment needed to achieve conformity to product requirements.

NOTE The term “work environment” relates to those conditions under which work is performed including physical, environmental and other factors (such as noise, temperature, humidity, lighting or weather).

Is it to say that the requirement here is to manage the 'work environment' only; and not to control/ manage the physical conditions which can affect it ?

 

[Sidney Vianna]

I have no desire to repeat myself.

In my view point, configuration management IS NOT a requirement from ISO 9001:2008. If you think otherwise, you are entitled to your opinion.

If the ISO TC176 interpretation process was working, we could easily request a "formal" interpretation. But that process is dead now.

Have a good weekend.

 

[samsung]

Re: Configuration Management

It's simple. If it were a requirement, it would be defined under the main topic 7.5 etc. Since ISO 9001 is written as a 'one size fits all' set of requirements, the TC 176 folks saw fit to guide users in the application of the requirement, by describing situations such as configuration management, as a method to meet the requirement.

There's no standard definition of 'Notes' in 9001 except for the clarification that "Information marked “NOTE” is for guidance in understanding or clarifying the associated requirement" from which it's pretty clear that any Note wherever referred, is an extension of the requirement "understanding or clarifying the associated requirement".

The 'Note' in 7.6 says ...."would typically include verification & configuration management.........". Isn't it a requirement among other things ?

 

[samsung]

I have no desire to repeat myself.

In my view point, configuration management IS NOT a requirement from ISO 9001:2008. If you think otherwise, you are entitled to your opinion.

If the ISO TC176 interpretation process was working, we could easily request a "formal" interpretation. But that process is dead now.

Have a good weekend.

Still we can wait for responses from the experts here.

I too wish you a nice weekend as well.

 

[AndyN]

Re: Configuration Management

There's no standard definition of 'Notes' in 9001 except for the clarification that "Information marked “NOTE” is for guidance in understanding or clarifying the associated requirement" from which it's pretty clear that any Note wherever referred, is an extension of the requirement "understanding or clarifying the associated requirement".

The 'Note' in 7.6 says ...."would typically include verification & configuration management.........". Isn't it a requirement among other things ?

No....and, no.

 

[AndyN]

Still we can wait for responses from the experts here.

I too wish you a nice weekend as well.

Since quite a few experts have already answered, it's not likely the story will change much, since they all basically agree that your position on this is inaccurate...We can wait to see if anyone else will weigh in, but Sidney pretty much summed it up.

 

[samsung]

Since quite a few experts have already answered, it's not likely the story will change much, since they all basically agree that your position on this is inaccurate...We can wait to see if anyone else will weigh in, but Sidney pretty much summed it up.

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."