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Requirement to link Quality Manual to ISO 9001 clause numbers?

Candi1024

Quite Involved in Discussions
#1
Our auditor stated this was a requirement. I can see where this can be useful, but I still can't find a requirement. This was listed as a recommendation for 9001, and in that recommendation it was stated we would required to do this for 13485, but no clause was given.
 
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Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#2
Whenever an auditor says something is a requirement, #1 question is "Please show me the requirement in the standard". Whenever an auditor says something is a "recommendation", the auditor has become a consultant.
 

blackholequasar

Involved In Discussions
#3
There is no requirement for this. As @Marc stated - this is a recommendation; which they should not be consulting - and there is nothing in any standard that states that this shall be done. Linking or even naming your SOP #s after clause numbers is not really a good practice as they are likely to change during revisions. So you'd have to go and update everything with each applicable revision change.
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#4
Our auditor stated this was a requirement. I can see where this can be useful, but I still can't find a requirement. This was listed as a recommendation for 9001, and in that recommendation it was stated we would required to do this for 13485, but no clause was given.
Amazing how resilient "Auditorsaurus Rex" is. That would have been an asinine recommendation in 1987, when ISO 9001 came about. In 2021 it is simply unacceptable. How is he reporting the audit results? Papyrus?

As blackholequasar mentioned, you want to future proof your Quality Manual, something that is no longer even required.
 

John Broomfield

Staff member
Super Moderator
#5
No such requirement exists.

A system manual may be useful to employees if it describes how their organization works as a system to determine and fulfill customer requirements. And how this system is monitored, reviewed and improved.

BTW, you may need to replace your auditor.
 

outdoorsNW

Quite Involved in Discussions
#8
While I think linking the quality manual, if you have one, to the clause numbers is helpful, there is no requirement. While doing so creates a bit more work when the standard being referenced changes, the extra work also forces you to look more closely at the revised standard and make sure you did not miss anything. We also reference key implementation documents in the quality manual. While not required, if you can't reference a process document, you are likely not compliant.
 

Candi1024

Quite Involved in Discussions
#10
Instead of rewriting the standard as your manual how about a single page matrix annex showing which parts of the documented parts of the management system contribute to conformity with each clause?
I think a matrix like this is useful in general. I'm just not sure if I will add it to the manual.
 
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