You are correct that there are some similarities between ISO 9000 and the FDA QSR. In fact the QSR was rewritten to coincide with ISO 9001 - 1994. The biggest difference is that ISO is a voluntary standard and the 21 Code of Federal Regulations (CFR) is not, this gives the audit a very different feel.

One thing to remember is that the QSR is a guide for meeting the requirements of 21 CFR Part 820 which is the part of federal law that applies to the quality system for medical device manufacturers. There are a number of other parts of the 21 CFR that apply to Medical Device Manufacturing that are outside the realm of ISO 9000 and there is a possibility that no other national or international standard exists for any given part of the CFR.

If you throw into the mix the Medical Device Directive from Europe and all the standards that apply it gets to be fairly complex.

It has come very far in the past 15 years or so thanks to the efforts of groups like the Global Harmony Task Force (GHTF), the FDA and ISO, but it is something that will take sometime for you to get your arms around and a little more time to become very proficient at.

Good luck

Jim Ecklein