P
phicarre
Anyone know if a guidance for the understanding of this norm exist or not ?
(how to fill each paragraph, etc...)
(how to fill each paragraph, etc...)
V
Vincnet
phicarre said:
hello phicarre,
I personnally use the "ISO/DTR 14969 Medical Devices - Quality Management systems- guidance on the application of ISO 13485:2003"
It recalls the ISO 13485 chapters in boxes and then explains what is meant by each clause. i love it!
I must say that appart from business issues and a clear aim to make a maximum of money out of standards, I do not understand why all what is in this guidance is not in the official iso 13485.
hope it helps
Vincent
P
phicarre
OK but this document is not free ...
Any other sources ?
Any other sources ?
A
Al Dyer
Yes, the person or corporation that holds the copyright to the priviliged document deserves to be paid. I believe if you contact them you may get a copy.
Documents that are free are worth the paper they are printed on.
I think I speak for the majority of the forum in that we are not about trading copyrighted douments. AGAINST THE LAW!!!
Al...
Documents that are free are worth the paper they are printed on.
I think I speak for the majority of the forum in that we are not about trading copyrighted douments. AGAINST THE LAW!!!
Al...
F
Frank34
Current 14969?????
Vincent,
I have not seen a version of 14969 for the application of the 13485:2003 standard. Where is this available? Anybody?
Frank
Vincnet said:
Vincent,
I have not seen a version of 14969 for the application of the 13485:2003 standard. Where is this available? Anybody?
Frank
F
Frank34
Al,
thanks for the help. Loads of information in this document.
thanks for the help. Loads of information in this document.
D
db
Frank34 said:
I've decided to stay away from 13485. With a supporting document like 14969, I know I will get it confused with 16949. I can just see me asking for a PPAP on a pap...oh never mind! :mg:
P
phicarre
How did you catch the famous document on aami.org ?
Did you buy it ?
Did you buy it ?
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