GAP Analysis for ISO 9001:2000 vs. ISO 13485:2003



Hello, I am brand new to the Forum, my name is Graham Simpson, I work for a company called McLaren Electronic Systems and i have a question. Has anyone got a link to a GAP Analysis doc for me to check the differences from ISO9001-2000 to 13485-2003 - Medical Devices? Here's hoping....




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Re: GAP Analysis doc ISO9001-2000 v 13485-2003

Welcome to the Cove, Graham! :bigwave:

Here are a couple of documents I've posted in other threads that may be useful to you:
This one is a comparison between ISO 9001, ISO 13485, and the US FDA regulations.
This one is a checklist for ISO 13485. Common text of ISO 9001 and 13485 is in black text. Anything that is added in ISO 13485 is in blue text, and anything deleted from ISO 9001 is in red text.

Hopefully these will be helpful to you...


Re: GAP Analysis doc ISO9001-2000 v 13485-2003

Thank you Howste, very prompt reply, I can see myself getting used to all this extensive knowledge ! I hope that I may be able to help someone in the same way......Have a great weekend ! Graham
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