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?
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.
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.
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.
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.
