ISO13485 File-Index getting too large

J

Jonas Wistrand

#1
Hello members!

I am working at a Swedish medical device company and we are currently setting up our QMS, hopefully in compliance with ISO13485. First audit will be conducted 31:st of August.

Anyhow, our documentation system is basically built upon:
* A document has to be released or revised at weekly meetings.
* A review of each document has do be performed by authorized personnel (at the weekly meeting)
* A table in a Word-document is working as an INDEX where all revisions are tracked. Hence, all valid versions at the time being can be read out from this document.
* Revision history in each document is explaining differences between versions (issues).
* Old versions are being saved in a "Record"-folder.

Lots of our important documents (i.e. Clinical Evaluation report) that are going to be submitted in the STED (Technical file audit) (notation according to:GHTF/SGlINOll:2008 <-- Google this document, since I was not able to post links before 10 posts) are referring to a bunch of documents, hence our INDEX is huge.

Now to the real question :)

Does anyone know a good way of dealing with this? I am thinking of maybe grouping large chunks of documents and then zip them and call the resulting ZIP-file the documentation. We are dealing with engineering files in the same way since a PCB may be described with thousands of files.

Would it be possible to disregard less important files from our main documentation file?

Any help or guidance about our documentation routine is very welcomed.

Best regards,
Jonas
 
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J

Jonas Wistrand

#3
I'm going to bump it myself. Any ideas? Or especially feedback on the idea of organizing with zipped-files.

//Jonas
 
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