Last year, we finished a AS9100 audit and a ISO13485 Audit, and a maintenance audit on our ISO9001. We just were notified that the auditor for the ISO13485 audit put in a change for our scope without telling us to add "of medical devices" to the end of the scope, thus limiting our entire scope of ISO9001 to ONLY medical devices.
We wholeheartedly believe that compliance can be applied from the perspective of best business practices, so we apply each of our compliances across our entire QMS, and do not have any separation aside from Medical Device Files, which we currently have none of (we mostly do prototypes in medical devices). During the audit, the auditor did mention the scope change as an Opportunity for Improvement, but we just ignored it as we did not want to limit our scope. The audit was not solely over the medical projects, so it did not make sense to us to do from the start.
I asked the CB what prompted the change, and found out that he had put it in his audit report that our scope needed to change. I wanted to ask if anyone here has experience with this issue before I respond further to our CB.
We wholeheartedly believe that compliance can be applied from the perspective of best business practices, so we apply each of our compliances across our entire QMS, and do not have any separation aside from Medical Device Files, which we currently have none of (we mostly do prototypes in medical devices). During the audit, the auditor did mention the scope change as an Opportunity for Improvement, but we just ignored it as we did not want to limit our scope. The audit was not solely over the medical projects, so it did not make sense to us to do from the start.
I asked the CB what prompted the change, and found out that he had put it in his audit report that our scope needed to change. I wanted to ask if anyone here has experience with this issue before I respond further to our CB.
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