Determining the Scope of the QMS during Stage 1?

AndyN

A problem shared...
Staff member
Super Moderator
#1
A recent experience with a Certification Body has me confused. I thought that the stage 1 was (in part) to determine the scope of the QMS and the appropriateness of any "exclusions" such as design. It is important to do this at the stage 1 since the stage 2 duration might need to be adjusted (by up to 20%) if the design process should be included (which would necessitate a requote of the Certification.

If no design process is applicable and the stage 2 goes ahead without inclusion of said process, how on earth can a major be written at the stage 2, for NOT including design?
 

Marc

Retired Old Goat
Staff member
Admin
#2
In the past... Most registrars had someone assigned to each client. I assume it's still the same. That person was to keep track of decisions on scope of registration, which would note any exclusions the client company was claiming. If an auditor "identified" a supposed nonconformance to an exclusion to the standard being audited to that has already been agreed to, the client would stop the audit and a call to the CB's client manager made to resolve the issue.

Prior to a stage 2 audit (actually prior to signing a contract with a registrar), the scope of registration has to have been agreed to. Sounds like the auditor isn't communicating with his/her employer very well, or has simply not properly prepared for the audit.

Edit Add: I will say that exclusion of design was rare in my experience. I remember a lot of service organizations wanted to get an exemption to design, but it came down to even services are designed.
 

John Broomfield

Fully retired...
Trusted
#3
In designing our consulting and training services for each client we first agree with the client the scope of their management system and their overall objectives for their system development project.

How does any organization get its management system ready for certification without a clear understanding of its scope?

I agree with you Marc, since day one we've advised clients to include the design of their services in their scope statement even when they think that all they do is make goods or products. Rarely did our clients use ISO 9002 or do they exclude any design process.
 

Sebastian

Involved - Posts
Trusted
#4
I am not surprised. Client informed CB that he is not design responsible at all and submit as evidence sample of design records received from customer. During stage 2 different sample was selected by auditor or process owner and then it crashed.

Typical failure of auditing like in case of interactions between remote supporting function and manufacturing site.
Remote supporting function shows perfect sample of support they give to manufacturing site, while blind sample selected during auditing manufacturing site shows that significant deficiencies exist in what they get from remote supporting function.
 

Eredhel

QA Manager
Trusted
#5
I may be misunderstanding something. Around here it's very common for job shops to do CNC machining with no design at all, everything is to customer prints and specifications. I would guess there are a lot of these suppliers that call the design section not applicable. I've built the QMS from the ground up for 2 such companies and never run into any pushback about that from auditors.
 

AndyN

A problem shared...
Staff member
Super Moderator
#6
I am not surprised. Client informed CB that he is not design responsible at all and submit as evidence sample of design records received from customer. During stage 2 different sample was selected by auditor or process owner and then it crashed.

Typical failure of auditing like in case of interactions between remote supporting function and manufacturing site.
Remote supporting function shows perfect sample of support they give to manufacturing site, while blind sample selected during auditing manufacturing site shows that significant deficiencies exist in what they get from remote supporting function.
Not what happened.
 

AndyN

A problem shared...
Staff member
Super Moderator
#7
In designing our consulting and training services for each client we first agree with the client the scope of their management system and their overall objectives for their system development project.

How does any organization get its management system ready for certification without a clear understanding of its scope?

I agree with you Marc, since day one we've advised clients to include the design of their services in their scope statement even when they think that all they do is make goods or products. Rarely did our clients use ISO 9002 or do they exclude any design process.
They did fully understand (it's a product not a service, btw) and the auditor was wrong (his management subsequently corrected the issue and he canceled the major nc he'd written)
 

AndyN

A problem shared...
Staff member
Super Moderator
#8
Typical failure of auditing like in case of interactions between remote supporting function and manufacturing site.
Remote supporting function shows perfect sample of support they give to manufacturing site, while blind sample selected during auditing manufacturing site shows that significant deficiencies exist in what they get from remote supporting function.
It's a single site, ISO 9001 and only 11 people. Why would this complication have anything to do with it?
 

Marc

Retired Old Goat
Staff member
Admin
#9
I may be misunderstanding something. Around here it's very common for job shops to do CNC machining with no design at all, everything is to customer prints and specifications. I would guess there are a lot of these suppliers that call the design section not applicable. I've built the QMS from the ground up for 2 such companies and never run into any pushback about that from auditors.
Registrars my clients worked with would have said: "You essentially do a service. How you take an order, etc. is design of your service."
 

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