FDA QSRs and ISO 9001:2000 - CFR 21 Part 820 and CFR 21 Part 58



I'm new to this forum, but have been lurking for awhile...

First of all, I would like to know how many of you are active or have been active in the FDA regulated arena. I have been in the Medical Device business for the last 15 years, about half of it in manufacturing and R&D and the other half in Quality Systems.

Secondly, with the advent of ISO9000-2000, do any of you have any strategic plans for the restructuring of your quality systems to reflect and be compliant to both the QSR and the ISO 9001-2000? Just when the FDA came out with the QSRs to harmonize with ISO, ISO changes! If you have such plans, would you be willing to share those? In your opinion, what is the biggest opportunity presented in the transition?

Thanks in advance for your input!

See you down life's highway!


Aaron Lupo

Eric, I also work for a Medical Device Company. IMHO if you are following the QSR's and are compliant to them I have no doubt you will meet the requirements for 9K2K. I have re-written our quality manual to meet 9K2K and thats about as much as we have to change, other than adding a section on Customer Satisfaction, and yes a procedure on how we do it. What I did rather than changing any documentation I made a cross reference of the documents from the old standard to the new standard. I hope this has helped if not e-mail me and I will try and explain myself better.

By the way we are CFR 21 Part 820 and CFR 21 Part 58.
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