Hello, I'm hoping someone can help. I was all set for our final audit for ISO 9000 when a new customer requested ISO 13485. We have no customers requiring us to get ISO9000 so we postponed the final audit. We are a small manufacturing company and our budget has been used for the ISO 9000. I have all our Procedures for ISO9000 and I was wondering if any one has general procedures for ISO 13485 that I can use as a template. Any help would be greatttly appreciated.

Thanks :)

Hello DJIND,

Welcome to the Cove!!

Have you reviewed the requirements under 13485?

Regards,

Kevin

Kevin,

Hi. Thanks for replying. I am currently in the process of re-writing our quality manual so it conforms to ISO 13485, so I am reviewing the requirements as I'm rewriting.

Diana

Hi

Are you talking about ISO 13485:1996 or ISO 13485:2003?

I think the best way to go about modifying your manual and procedures is by doing a gap analysis and identifying what is missing.

Danny

Danny,

Hi. Thanks for replying. I am currently re-writing our manual to the ISO 13845:2003 and at the same time trying to identify what's missing. I downloaded from this site an Audit checklist which highlights the differences between ISO 9001:2000 and ISO 13485:2003 which I believe will help.

Thanks
Diana

Hi,Diana,

If you try ISO 13485:2003,more procedures are needed than ISO 13485:1996.At the same time,risk management through the whole product realization processes required in 7.1 of ISO 13485:2003 needs much more documents and records from you than just a risk analysis documentation in design process as required in 4.4.1 of ISO 13485:1996.

Liuyy :)

Hi Diana,

Have you searched the cove for other threads? I placed a link to a web site that has templates, in this thread http://elsmar.com/Forums/showthread.php?t=8098