Scope in Quality Manual vs. Certification Audit Application Scope

[dsanabria]

In Reply to Parent Post by Big Jim

I don't think you got this quite right.

The scope of the quality management system must be in the manual per 4.2.2 a. Often, a short scope of the quality management system is sought by the CB for your certificate. They don't have to be worded exactly the same, but it would be expected that they in essence convey the same description. That is, manual says you manufacture jewelry and the one for your certificate says that you assemble fire engines, they don't begin to match.

Another point to be very careful about is that your manual needs to describe the scope of your system (4.2.2 a). What I often find is that the manual describes the scope of the manual, which is not what 4.2.2 a requires.

I write a nonconformance on those every time I find them.

Big Jim

The answer was in relations to the following Question and not a definition of scope.

In Reply to Parent Post by Chuot Ly

Does the scope describe in quality manual has to match with the scope we put on the certification audit application?

So that we are all in the same page - I am curious - what would be your answer to the posted question?.

and

Can you give an example of when you would issue an NCR. It would help people reading this in developing a better understanding of the standard.

Thanks -

[Big Jim]

In Reply to Parent Post by dsanabria

Big Jim

The answer was in relations to the following Question and not a definition of scope.



So that we are all in the same page - I am curious - what would be your answer to the posted question?.

and

Can you give an example of when you would issue an NCR. It would help people reading this in developing a better understanding of the standard.

Thanks -

I think I did answer the question. What else about the question would you like me to commont on besides what I might write a nonconformance for?

An example of a scope of the manual that doesn't speak to 4.2.2 a would be:

"This manual describes the activities at abc company."

[Jim Wynne]

In Reply to Parent Post by Big Jim

I think I did answer the question. What else about the question would you like me to commont on besides what I might write a nonconformance for?

An example of a scope of the manual that doesn't speak to 4.2.2 a would be:

"This manual describes the activities at abc company."

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?

[Big Jim]

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.

http://www.gsprogress.us/Resources/A...x_25_Scope.pdf

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.

[Buckyb]

Here is food for thought. In our recent AS9100 Audit we were was asked to provide on-time delivery and acceptance/reject rates report card from our customers based on AS9101D, item 65. I reminded the Auditor that we had only one customer which was identified in the scope of our Quality Manual and in the scope of our certificate. No other customers require us to meet such goals with them. Although our QMS provides guidance to the organization as any quality system would do, only the records, documents of our one customer should be audited as a result of our scope. One can argue that the QMS is used throughout our organization to ensure product conformity and it is; but again, our scope identifies only one customer. Based on the scope of the QM and certificate, how would you audit?

[Sidney Vianna]

In Reply to Parent Post by Buckyb

Based on the scope of the QM and certificate, how would you audit?

If the auditor is not paying attention to the scope of certification, when planning, performing and reporting the audit, s/he is not demonstrating competence.

[Buckyb]

Point taken Sidney. The Auditor had a senior moment I think. He was exceptionally competent, thorough and fair in the Audit. My point exactly though, the scope of the QM and certification is the foundation for the Audit.

[Big Jim]

There has been a reasonably prevalent attitude that if an organization is registered to AS9100 that it automatically applies to everything they do. Fortunately it is less prevalent today than it was a few years ago, but as this example shows it still has a toe hold.