Hi all,
I was looking for some document that summarize the ISO 13485 and based on ISO 14969. I need it to train new comers. Can anybody help.

Hi all,
I was looking for some document that summarize the ISO 13485 and based on ISO 14969. I need it to train new comers. Can anybody help.

Hello ISO MAN,

Here is some info that I found. It may not be exactly what you're looking for, but it may be a start.

http://www.asq-silicon-valley.org/iso-grp/Presentations/iso13485_101706.pdf

http://gmplabeling.com/catalog/news0605.pdf

Also, click on the links at the bottom of this page.

Stijloor.

If I understand your post correctly, I know where to find the information but I can't just give it to you because it's copyright protected.

If you buy the standard ISO TIR 14969:2004, you will find Appendix B, which is entitled "Analysis of Significant Changes from ISO 13485:1996 to ISO 13485:2003."

Otherwise, you should contact your Notified Body, i.e. the company that gave you your ISO 13485 certification. They should most definitely have this kind of summary document.

Try, ISO 13485 2003 PLAIN ENGLISH LIBRARY (http://www.praxiom.com/iso.htm)