QAP's editing or rewriting

[Sweenman1957]

Is the phrase "not used" acceptable in place of a clause?
Example :
2.2 Not used

 

[John C. Abnet]

Good day @Sweenman1957 ;
Please elaborate and provide some context. Are you asking if your organization's scope of certification can indicate that a specific clause of the ISO standard is not relevant (i.e. 'not applicable') to your organization?

 

[Sweenman1957]

Yes after and audit of QAP 10.1 several sub clauses were marked (2.1.1) "Removed" or (2.2.2) "Not Used".
Can these terms be left or does the entire QAP need to be rewritten and renumbered?

 

[Ed Panek]

ISO 13485 Allows exclusion to sterilization, service and installation. I imagine 9001 has something like this. Although 9001 is rather basic. I wonder what could be ommited?

 

[Sweenman1957]

We are ISO 9001-2015. QAP 10.1 refers to Inspection and Testing. The Technical Director reviewed and under Responsibilities he removed 2.1.4 and wrote in "Removed". In 2.2.2 he wrote "Not used" etc. Need to know if these phrases can stay of do I need to rewrite the whole QAP with new numbering?

 

[geoffairey]

Is the phrase "not used" acceptable in place of a clause?
Example :
2.2 Not used

If the alternative is to rewrite the document and invalidate references in other documents, “not in use” seems a reasonable way to remove something which is no longer valid. You’ll have old versions maintained of course if an auditor wanted to see what had been removed and explore why that was the case.

 

[John C. Abnet]

Yes after and audit of QAP 10.1 several sub clauses were marked (2.1.1) "Removed" or (2.2.2) "Not Used".
Can these terms be left or does the entire QAP need to be rewritten and renumbered?

Good day @Sweenman1957 ;
Still unclear of your references...
* What does "QAP" stand for ?
* Are you referencing ISO 9001:2015 clause 10.1 - Improvement (General) ?
* You are placing "removed" (2.1.1) and "Not Used" (2.2.2) in quotes as if you are pulling these terms from a document or standard. Where are you
pulling these terms (and referenced numbers...e.g. "2.1.1") from ?

Thanks in advance for helping us help you.

 

[Sweenman1957]

QAP=Quality Assurance Procedure
I only put quotes on the words because those are the ones I have questions about.
Prior to Audit QAP 10.1 sub clause 2.1.4 read:
2.1.4 Releasing final product for shipment for product outside manufacturing specification limits, but within sales specification limits.

After Audit 2.1.4 read:
2.1.4 Removed

is leaving that as is acceptable or do I need to redo the entire 10.1

 

[Big Jim]

I think you are asking about how to handle changes in your company's documents, possibly the quality manual itself. If I understand, you are asking if some of your company's clauses can be noted as no longer applicable or is it necessary to rewrite the manual.

First of all, you are not required to have a quality manual. Many companies chose to have one, partly from heritage and probably mostly to provide structure to your quality management system. Since it is not required to have one, it is up to the company to determine how to update it.

I hope this helps.

 

[John C. Abnet]

Good day @Sweenman1957 ;
Still unclear of your references...
* What does "QAP" stand for ?
* Are you referencing ISO 9001:2015 clause 10.1 - Improvement (General) ?
* You are placing "removed" (2.1.1) and "Not Used" (2.2.2) in quotes as if you are pulling these terms from a document or standard. Where are you
pulling these terms (and referenced numbers...e.g. "2.1.1") from ?

Thanks in advance for helping us help you.

What @Big Jim said.

In addition to what @Big Jim said,...while there are requirements in 9001 for 'maintain documentation", which can imply a procedure, work instruction, etc.., there is no specific requirement for 'procedures'. Be careful not to create documentation simply for the sake of documentation (i.e. to please some auditor).

In regard to your specific example, ...do what's best for your organization.

Hope this helps.
Be well