In Reply to Parent Post by Jim Wynne
The scope of the manual--what the manual applies to--should be the same as the scope of the QMS, no? Does the manual govern anything outside the scope of the QMS?
I should have posted this link earlier. This is a link to the Auditing Practices Group where they provide guidance or definition for three types of scope that may be encountered when dealing with ISO 9001:2008.
There are three main topics:
Scope of ISO 9001:2008,
Scope of the quality management system (QMS), and,
Scope of registration.
Concerning the scope of the QMS:
"The scope of the QMS should be based on the nature of the organization's products and their realization processes, the result of risk assessment, commercial considerations, and contractual, statutory and regulatory requirements."
Concerning the relationship between the scope of the QMS and the scope of registration:
" . . . the scope of registration/certification encompasses the scope of the QMS, as well as describing any excluded ISO 9001 requirements."
We all know by now that clause 4.2.2 a requires that the quality manual includes a scope of the quality management system including justified exclusions. The Auditing Practices Group provides some insight to what that scope needs to include (linked above in full for those who want to read the entire thing).
In an earlier post I mentioned that many certification bodies also want a short version of the scope to keep the space on the certificate from getting out of hand.
Now to Jim Wynne's question as to if the scope of the quality management system is or should be the same as the scope of the quality manual.
First of all, the quality manual must include more than just the scope statement. Clause 4.2.2 also requires the quality manual to include the documented procedures (or reference them), and a description of the interaction between the processes.
So I would guess that it may depend on what all is included in the quality manual as well as what is in the scope statement. A quality manual that has the minimum requirement doesn't seem to be one that would equal the quality management system. A scope statement that only talks about the manual and makes no mention of the quality management system does not seem to be one that would match the requirements for a scope statement.
So, I would say that it may be possible for the scope of the QMS to be the same as the scope of quality manual, but I don't think it happens often.
I already provided an example of a scope of the manual that didn't meet the requirements of the scope of the quality management system.
Anyway, that's how I see it.