Guidance for Understanding ISO 13485

R

rose24m03

#21
Iso14969

you should get the released version ISO14969:2004

per ISO 13485:2003, documents of external origin (e.g. ISO standards, customer's documents) need to be controlled

the good old document control requirements are still here to stay. you need to have current version at point of use. obsolete version needs to be removed promptly to prevent accidental use.

registrars usually are very strict on documents of external origin. that means, no copies should be made from original purchased standard. (we got written up by our registrar years ago)
 
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M

Megani

#24
Hi Al!

I'd like to get a copy of this draft as well, but everytime I tried to put in the information in the link you gave, I could not pull it up. Can you help!?
 

Al Rosen

Staff member
Super Moderator
#25
Megani said:
Hi Al!

I'd like to get a copy of this draft as well, but everytime I tried to put in the information in the link you gave, I could not pull it up. Can you help!?
Which link are you referring to?
 
Q

Quality Queen

#26
I believe that you can no longer get the draft version because there is a released version now. So you'll have to purchase the released version.
 
M

Megani

#28
Another Book that you might prefer

Another book is the "Regulatory Compliance Almanac" by Les Schnoll. It is a new book, well written, that explains most aspects of the GXPs as well as the MDD and QSR. I like this book very much! Paton Press carries it.
 
R

rose24m03

#29
comment on "The FDA and Worldwide Quality System Requirements Guidebook for Med Dev"

comment on "The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices Trautman, Kimberly A., GMP/Quality Systems Expert (compiled by)"

though it is a good reference, it might be cheaper to just download the 21 CFR Part 820 preamble (free from FDA web site) and pay for a copy of TR/ISO 14969:2004. Reasons: The 13485 and 46001 mentioned in the book are the old versions. And, you can find out what FDA's comments are on the QSR Part 820 from preamble. If you get the PDF version, it is a lot easier to search.

:read:
 
D

Dan LaBelle

#30
My organization just had our 3rd Party Re-certification Audit to MDR, CMDR, and ISO 13485:2003. We successfully passed the audit and will be recommended for certification by our 3rd party auditors.

The only standard I bought was TIR 14969:2004 from AAMI. It was very helpful. What I do recommend is having an outside consultant do a full internal audit cycle to ISO 13485:2003. It was a little spendy but well worth every penny cause it saved us tremendous amount of time and had excellent feedback from the audit which ultimately led to our successful audit.

The hard part is finding a really good outside consultant worth the bang for the buck.

On the FDA side, I only use the book by Trautman ,"The FDA and Worldwide ...." I am hoping that she comes out with a new revision that is more up to date.
 
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