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

S

senna

#1
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
 
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S

senna

#3
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. :nopity: (Probably because 13488 is being phased out in the near future in leau of 13485 with exceptions.)

Senna
 
A

Aaron Lupo

#4
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. :nopity: (Probably because 13488 is being phased out in the near future in leau of 13485 with exceptions.)

Senna

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.
 

Ajit Basrur

Staff member
Admin
#5
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Both these are withdrawn and replaced by ISO 13485:2003.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
 
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