Hi everyone - I just wanted to know if anyone out there could recommend any text books relating to ISO 13485 (& ISO 17025 come to think of it!). I've seen several on a few websites but wondered if anyone thought they were worth the money!

Any advice gratefully appreciated!

Hi cefulton:
Yours is a good question-I have purchased books in the past and found they were not what I needed.
I found ISO 14969 (maybe still in draft version?) to be of help understanding ISO 13485. It is named "Medical Devices-Guidance on the application of ISO 13485:2003. I got my copy thru BSI auditor training.
Good Luck
Bridget

i agree with bridget
see this thread Guidance for Understanding ISO 13485 (http://elsmar.com/Forums/showthread.php?t=8846) about ISO 14969. I found the draft very usefull. In fact as I said in the other thread I do not understand why all what is said in ISO 14969 is not in ISO 13485.

Well in fact I understand that it is an easy way to make money :tg:

V

Thanks for the suggestions - I thought though that the 14969 was not available yet? A colleague recently went to a training seminar and was told it was not yet available. I checked out the aami website and could only find the ISO 14969:1999. Would the 1999 version still be applicable for the latest (2003) ISO 13485 version?

Regards,

Ciaran

I use the ISO/DTR2 14969 published on the 27-Oct-2003it's not the final but shouldn't be far from it.