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View Full Version : Need sample procedures for ISO 13485:2003


Yong Kil, Kim
10th August 2005, 09:20 AM
Hi...
I need to sample documented procedure for my reference...For Example
- Internal audit Procedure
- Management Review Procedure
- Medical Device Incident/Acident Procedure

What are your thoughts on this?

Help!!!

Thank you all in advance!

Marc
11th August 2005, 04:15 AM
I think the Internal Audit procedure and Management Review procedure are pretty much the same as for 9001. There are a bunch of these on the site if you look around (check the attachments listing and the free files direectory).

Anyone have an example Medical Device Incident/Accident procedure and/or form?

nickh
19th August 2005, 06:40 AM
Check the FDA's site for the incident / accident report form. I know I've seen one there before. Bonus: their material is freely downloadable.