Common items : which iso 9001 are common to all areas?

Graciel

Involved In Discussions
#1
Hi!
Looking at iso 9001, which items you guys consider is common to every area of the company ( production, purchase, engineering,hr, sales...etc)? I mean, that all areas are questioned by the auditor.
Thanks.
 
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Mikey324

Quite Involved in Discussions
#2
Not sure what you mean. That's a very broad question. Auditors will audit all the requirements. Maybe not product design if you have no design responsibility.
 

Jim Wynne

Leader
Admin
#3
Hi!
Looking at iso 9001, which items you guys consider is common to every area of the company ( production, purchase, engineering,hr, sales...etc)? I mean, that all areas are questioned by the auditor.
Thanks.
Auditors will audit all of the processes you've identified as being within the scope of your QMS.
 

Tagin

Trusted Information Resource
#4
All clauses (4-10) apply to all processes.

Typically though, 4,5,10 are mostly handled by processes that are shared across the organization. But even then, you want to be able to show how, for example, nonconformances in purchasing are escalated to the shared corrective action process.

So, for example, you need to address documented information (7.5) in all the areas you listed (production, purchase, engineering,hr, sales...etc). You could do that with separate QMS documentation for each area, or you could have shared QMS documentation that talks about 'documented information' in all areas. It is up to you, as long as it is covered.

Some clauses may not apply to some areas. E.g., Design (8.3) is probably not going to apply to your shipping department. That's fine. As long as you can justify it.
 

Graciel

Involved In Discussions
#5
All clauses (4-10) apply to all processes.

Typically though, 4,5,10 are mostly handled by processes that are shared across the organization. But even then, you want to be able to show how, for example, nonconformances in purchasing are escalated to the shared corrective action process.

So, for example, you need to address documented information (7.5) in all the areas you listed (production, purchase, engineering,hr, sales...etc). You could do that with separate QMS documentation for each area, or you could have shared QMS documentation that talks about 'documented information' in all areas. It is up to you, as long as it is covered.

Some clauses may not apply to some areas. E.g., Design (8.3) is probably not going to apply to your shipping department. That's fine. As long as you can justify it.
Hi! Thanks for feedback.
I wonder, can a company define item 8.5 as not applicable?
 

Graciel

Involved In Discussions
#6
Auditors will audit all of the processes you've identified as being within the scope of your QMS.
I know. What I mean is: item 6 for example (6.1, 6.2 etc) ,can be checked in every area of the company. But 8.3 (if applicable) will be checked in one area only.
Which items would be common to all the areas?
 

Tagin

Trusted Information Resource
#7
Hi! Thanks for feedback.
I wonder, can a company define item 8.5 as not applicable?
It would seem extremely unlikely that 8.5 Production and Service Provision could be not applicable. An organization takes inputs, transforms them, and creates outputs. I can't imagine an organization that doesn't do that.
 

Graciel

Involved In Discussions
#8
It would seem extremely unlikely that 8.5 Production and Service Provision could be not applicable. An organization takes inputs, transforms them, and creates outputs. I can't imagine an organization that doesn't do that.
Hi!
Sorry. I forgot to put the sub item,which it'd be 8.5.1 h) . About post delivery activities.
 

malasuerte

Involved In Discussions
#10
Hi!
Looking at iso 9001, which items you guys consider is common to every area of the company ( production, purchase, engineering,hr, sales...etc)? I mean, that all areas are questioned by the auditor.
Thanks.

Yes...this should be part of what your audit program builds; plus it is what (as far as I know) registrars require for audits.

You would build a matrix like this with clauses on the vertical and areas on the horizontal.




1650327491839.png
 
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