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Where to add SOP of writing a Technical File in ISO 13485?

V

vincentgau

#1
Hi,

We already have a ISO 13485 QMS in placed and we have passed the Stage I audit. We just found that we put SOP Technical File in 8.5.5, which I know this might not be right.
Where should we put the SOP Technical File in ISO13485?

Thanks.
 
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I

isoalchemist

#2
I'm not sure of the question. ISO 13485 stops at 8.5.3 Preventative Action so .......

The Technical File is really an output of the Design Process (7.3). The Technical File is just the compilation of the records required so I'm still confused. If you have an SOP as to what the Technical file consists of you could go 7.3 or Document Control.

It is really what your system says and what makes the best business sense. You can put it whereever you want. You just may have to explain it to the auditors if it is really misplaced, but it is your choice.
 
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