21CFR820 vs. ISO 9000:2000 - Cross Reference Matrix Attached

[RCW]

Somebody help me!

I am updating my quality manual from ISO 9000:1994 to ISO 9000:2000 HOWEVER.....in addition I need to add in references to 21CFR820.

Comparing 21CFR820 to ISO9000:1994 isn't too bad but it looks a lot messier comparing it to ISO9000:2000. Does anybody out there have a handy-dandy cross-reference between 21CFR820 and ISO9000:2000? Also does anybody have a quick reference on the additional requirements for 21CFR820 that aren't covered in ISO9000:2000?

I was planning to put a cross reference in the index of my quality manual.

Also I read somewhere that 21CFR820 was in the process of being updated to align with ISO9000:2000 (or was that a whole new ISO medical spec?).

Any help would be appreciated!

 

[Alf Gulford]

Hi, RCW-

The last I heard, the FDA has declared that they will harmonize with ISO 13485:200x instead of ISO 9001:2000. If you're medical device you need to order a copy of that. All that's out is the Committee Draft right now, but the word on the 'street' is that the final version isn't expected to change much.

I've got a matrix with ISO 9001:1994, ISO/CD 13485:200x and FDA 21 CFR, part 820 that I created for my next Quality Manual. If I can figure out how to do so, I'll be glad to share it with you (but no guarantees of accuracy, caveat emptor). I didn't have much luck recently with Avatars but I'll take a shot at this in the next day or so.

Alf

 

[Alf Gulford]

RCW-
Here's the matrix I was talking about. Again, probably only useful if you're medical device and selling in Europe and/or Canada. You can also check other threads in this category and find more info on ISO 13485.

Alf

 

[Bubba]

Alf,

Thank you for posting the matrix. It looks like a great reference that I plan on keeping on hand.

 

[Alf Gulford]

My pleasure, Bubba.

If it's worth anything to anyone, I found a 4 way matrix I made that also includes 9001:2000. My problem is that I did it several months ago (before we made the decision to go with 13485) and can't remember if I final proofed it or not. I do remember that trying to match everything perfectly was a miserable task and I wouldn't want anyone to bet their job on the result.

Alf

 

[RCW]

A hearty thumbs-up!

Thanks Alf!

That 4-way matrix looks like exactly what I need. I will double check the cross-references you gave but that table definitely puts a big dent into what I need to get done.

Thanks again!