AS9100 Change in Registration Scope - Audit Nonconformance

K

kevwb

#1
Advice please,

We recently underwent a re certification audit and have asked our scope to be changed, the removal of a service we no longer provide. During the audit a minor NC was raised because we had not changed this in our manual, do you consider this to be a valid NC particularly since our scope within our manual accurately reflects what is detailed in our current certificate.

Conversely if we had changed our scope would we have received an NC for it not matching our certificate.

Thanks in advance
 
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K

kevwb

#3
Re: AS9100 Change in Scope

Thanks for the fast response, the NC stated

" Mi 1 - The organization shall establish and maintain a quality manual that includes a) the scope of the quality management system, including details of and justification for any exclusions.

[FONT=&quot]Scope is incorrect."

Hope this helps and thanks.
[/FONT]
 

Big Jim

Trusted Information Resource
#4
Re: AS9100 Change in Scope

I think the auditor was out of place. You had not altered the scope yet, so it was correct. You were exploring the change.

I would encourage you to talk to the registrar about lifting the NCR.

That said, this could have been avoided if you would have talked to the registrar and settled this before the audit, which is really the best approach.
 
#5
The scope of your QMS doesn't need to be the same as the scope of certification - the auditor is incorrect. You should talk to your CB and have them remove the NC and discuss why their auditor thinks this is OK to create such a finding. Your CB contract should state the scope of your certification and the auditor is supposed to audit to that - it's called the "scope" for that very reason!
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#6
The scope of your QMS doesn't need to be the same as the scope of certification
I agree, Andy.
Your CB contract should state the scope of your certification and the auditor is supposed to audit to that - it's called the "scope" for that very reason!
Although the question is related to AS9100, the ISO APG Paper on Scope of the QMS and Scope of Certification still applies.

From what the OP mentioned, the CB auditor wrote up the nonconformity because the organization's QMS scope is not accurately described in the Quality Manual. The paper hyperlinked above now has a paragraph that reads
As an additional measure to combat potential confusion among customers and end users, the scope of registration/certification should be clearly defined in the organisation's Quality Manual and any publicly available documents (this includes, for example promotional and marketing material).
 

Big Jim

Trusted Information Resource
#7
Anyone studying this should read the entire paper that Sidney linked. Don't go too far off on the tangent that the two scopes don't need to be the same. My reading of it certainly leaves me with the feeling that they need to be compatible.

The linked paper appears to talk about three scopes.

Scope of the QMS

Scope of registration

Scope on the certificate

All three could be different.

Element 4.2.2 requires that the quality manual include the scope of the QMS plus the justification of any exclusions.

The linked paper seems to say the same thing about the scope of registration, in that the scope of registration needs to include the scope of the QMS plus details about any exclusion.

The linked paper then goes on to explain that the scope on the certificate may be a synthesized description that does not include details about any exclusion.

The linked paper then goes on to explain an auditor's obligation in confirming that the scope statement is correct and not misleading.

It appears that the auditor was simply trying to do his job, which takes me back to my earlier comment that this should have been addressed with the registration company prior to the audit, and if it had of been, all of this could have been avoided. After all, registrants are required to notify the registration company when significant changes are made. It is always best to notify them sooner than later, and not just wait for an audit.
 

Big Jim

Trusted Information Resource
#9
Andy,

Before I answer that I want to remind anyone reading this that in my first post in this thread, I said that I felt the auditor was out of place in writing the NCR and I still feel that way.

Now as to if NCRs can be written against an ISO APG guide, lets look at that.

The material provided by the Auditing Practice Group (APG) is available on the ISO web site. It is included in the TC 176 area. TC 176 is the Technical Committee that wrote ISO 9001 and maintains it. This material is provided as guidance for auditors.

I'm aware of the disclaimer on every one of the APG papers that the material has not been vetted, but yet TC 176 has it posted on their web site for guidance.

NCRs need to be written against the standard, but the APG material provides guidance for doing so.

Perhaps you see it differently.
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#10
Can a CB auditor write an NC against a ISO APG guide...?
The answer is a resounding NO. But, as described in post #3 of this thread, the NC was written against 4.2.2, for failure to maintain the scope of the QMS properly identified in the manual.

Personally, I think this is one of those tic tac nonconformities that, while "technically" correct, does not add any value to the organization's QMS. This finding would have been much better reported as an observation, to be followed up with the organization, at a later date.
 
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