ISO 9001 Scope of R&D/IT sites

N

Natanya

#1
Our company currently has multiple manufacturing sites under a common corporate cert. R&D sites, which conduct our design work, and IT sites, which program and maintain our SAP system, are not in scope. These sites do not have a formal calibration program, training records, audits, etc.... Is this a problem? Would it make a difference if these sites collocated to our manufacturing plants? Thanks for your feedback.
 
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T

Ted Schmitt

#2
Re: ISO9001: Scope of R&D/IT sites

Our company currently has multiple manufacturing sites under a common corporate cert. R&D sites, which conduct our design work, and IT sites, which program and maintain our SAP system, are not in scope. These sites do not have a formal calibration program, training records, audits, etc.... Is this a problem? Would it make a difference if these sites collocated to our manufacturing plants? Thanks for your feedback.
Welcome to the Cove !

How do you attend 7.3 if R&D is not in your scope? What justification did you present to your CB?

If the IT dept is in another site and they maintain your SAP system, it should be considered at least as a supporting process within your QMS.

From the info you supplied, I would consider this a problem and would want to see all sites that do the R&D work and your IT dept under the QMS umbrella.
 
N

Natanya

#4
Re: ISO9001: Scope of R&D/IT sites

We have been certified since the early 1990s. R&D has always been out of the scope of cert; IT moved off site about 10 years ago. The CB has never asked or addressed our cert scope or structure.
 
T

Ted Schmitt

#5
Re: ISO9001: Scope of R&D/IT sites

We have been certified since the early 1990s. R&D has always been out of the scope of cert; IT moved off site about 10 years ago. The CB has never asked or addressed our cert scope or structure.
Where you 9002 back then?

How do you justify exclusion of 7.3 ??
 
N

Natanya

#6
We had some sites that claimed the 9002 'exemption'; but not all of the sites. The sites that did claim the exemption deferred all R&D work to the non-certified R&D site.
 
T

Ted Schmitt

#7
We had some sites that claimed the 9002 'exemption'; but not all of the sites. The sites that did claim the exemption deferred all R&D work to the non-certified R&D site.
So you had some sites that where certified 9001 and some 9002 is that it?

And how do you justify exclusion of 7.3 under your present system ?
 
N

Natanya

#8
That is correct - we have sites with and without the exclusion in the past. Now, all of our sites have 7.3 in scope - we claim no exclusions. When auditors come in they meet with R&D individuals at our manufacturing sites; but no auditor has every asked to see the R&D site or asked whether it was in scope or not. I am unclear if this is a common practice or if we have been skirting an issue for years w/o an auditor noting.
 
T

Ted Schmitt

#9
That is correct - we have sites with and without the exclusion in the past. Now, all of our sites have 7.3 in scope - we claim no exclusions. When auditors come in they meet with R&D individuals at our manufacturing sites; but no auditor has every asked to see the R&D site or asked whether it was in scope or not. I am unclear if this is a common practice or if we have been skirting an issue for years w/o an auditor noting.
It´s hard to say with the info provided but I´m guessing that when the auditors "meet with the R&D individuals", they are being shown evidence that your organization complies to 7.3
 
#10
That is correct - we have sites with and without the exclusion in the past. Now, all of our sites have 7.3 in scope - we claim no exclusions. When auditors come in they meet with R&D individuals at our manufacturing sites; but no auditor has every asked to see the R&D site or asked whether it was in scope or not. I am unclear if this is a common practice or if we have been skirting an issue for years w/o an auditor noting.
I would have expected that the auditor would have visited the R & D responsible sites to be able to perform an implementation audit, rather than review records at another site (manufacturing).

It is impossible, without interviewing the responsible personnel, to determine the status of implementation from simply looking at records - which could (by some organizations) have been prepared - to look conforming - before hand! In many cases the time allocated to the auditing of R % D functions is (at the initial certification audit) a fairly substantial amount, due to the complexity of the process and requirements. I'd personally doubt if you got a 'fair shake of the stick' from what you describe!

I believe you've had a CB who has been skirting the issue and, as a result, your certification - particularly if an accredited one - is dubious, especially since design is a fundamental part of getting 'quality' right!!

I know it's double jeopardy, but I believe your organization needs to take control with your CB (or find an alternate) and stop them putting your certification under risk like this!
 
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