13488:1996 vs. 13485:2003 Gap Analysis Matrix Spreadsheet

Hi Ya'll!

Does anyone have a gap analysis matrix between 13488:1996 and 13485:2003? A list of needed procedures/QS docs to make the transition from 13488 to 13485 would be of great help as well.

Thanks!

Senna

Try this thread ISO 13485 Medical Devices QMS - Requirements for Regulatory Purposes Checklist and this thread ISO 13485 - List of required / needed procedures and records
If you don't find what you're looking for try doing a search in the attachments and threads.

Al,

I checked all the info on the Cove before posting and saw a ton of info on 13485:2003, but didn't find anything about 13488:1996. (Probably because 13488 is being phased out in the near future in leau of 13485 with exceptions.)

Senna

senna said:

Al,

I checked all the info on the Cove before posting and saw a ton of info on 13485:2003, but didn't find anything about 13488:1996. (Probably because 13488 is being phased out in the near future in leau of 13485 with exceptions.)

Senna

Click to expand...

I am pretty sure there is a gap analysis or a powerpoint presentation out there. In fact I know I have posted a couple of different files that explain the differences between 13485:96 and 13485:03.

Re: Seeking 13488:1996 vs. 13485:2003 Gap Analysis Matrix Spreadsheet

Hi all,

Just as an update -

There were 2 standards earlier viz.

ISO 13485:1996 (Quality systems -- Medical devices -- Particular requirements for the application of ISO 9001) and

ISO 13488:1996 (Quality systems -- Medical devices -- Particular requirements for the application of ISO 9002)

Both these are withdrawn and replaced by ISO 13485:2003. Refer ISO website