ISO 13485 Clauses 7.5.3 and 8.4 - Examples of procedures wanted

[t845526 - 2007]

Regarding to these chapters you need a specific procedure. Does anybody have an example or can tell me where to find it?

Many thanks in advance.

 

[Al Rosen]

Regarding to these chapters you need a specific procedure. Does anybody have an example or can tell me where to find it?

Many thanks in advance.

Here is an example of what they might look like. You should tailor them to your company's actual processes.

 

[t845526 - 2007]

Thank you very much. This will be very helpfull...

 

[enoch_c - 2004]

thank you so much ... helpful

 

[lisar]

Thank You! Very helpful!

 

[Greg316]

Re: 13485:2003 7.5.3 and 8.4 - Seeking examples of procedures needed for these clause

Very helpful, thanks!

 

[Ranileom]

Here is an example of what they might look like. You should tailor them to your company's actual processes.

Thanks useful

 

[Dvipika]

Thank u so much,

do we need any records to prove that we do data analysis and if so wat kind of records do we need to maintain

 

[alworthen]

Yes the standard requires records of the results of the ananlysis of data to be maintained.