ISO 13485 Medical Devices QMS - Requirements for Regulatory Purposes Checklist

[rick melton]

Greetings everyone,
I am a newcomer to the forum, so I am learning the process. I have seen some interesting topics and think this will be very helpful.
I am the Corp Quality Systems Assessment Manager, for a medical company.
All of our divisions and corporate are registered to ISO 9000 and are registering to ISO 13485-2003. I am looking for an audit checklist that will cover all of the requirements. Any recommendations. (I saw one posted by the ISO Guy, but could not open it.)

Thanks in advance fro your help.

Rick

[Aaron Lupo]

If you let me know your e-mail address I would be more than happy to e-mail it to you.

[Cathy]

Hi Rick,

I have made up this check list to allow me compare additionally requirements to ISO9001;2000. This table needs to be used along side ISO9001;2000 as only the changes are noted here. I have also compared to ISO13485:1996. Hope it is of some use.


Cathy

[howste]

Cathy - that looks like a useful tool to compare the standards. I'll be doing a 13485 audit in December, so I'll probably use this spreadsheet to look at the changes.

Thanks!

[Karichan]

Hi Cathy

Your attached checklist is very useful for me to introduce the changes of new version of ISO 13485 to my students.

[pcomley]

Dear ISOGUY
I too would most apprecaite a copy of your checklist. Going crazy converting.

Many thanks
Pete

[electronics guy]

Dear ISOGUY,

A very popular bit of information you have put together!

THANKS!

[dacindustries]

I would be interested in a ISO 13485 checklist and aslo a gap analysis. Anyone help?
I am a consultant that deals woth ISO and AS, but new to the medical.