ISO 13485 Help - Determining what processes I specifically need to document

D

debeast

#1
Hi all,

A little while ago i posted regarding CE certification for a new medical product .

I'm now a little further along in the process and a lot more understanding of whats needed for CE certification :)

I'm now at the ISO 13485 stage and was wondering if anyone could recommend a good resource for a novice :)

The product itself is a class 2a medical device used for the automated diagnosis of spinal problems from CT scans.

I want to work out what processes i specifically need to document and what processes i actually need to complete and then document!

I did find a good post here with a checklist but am after a bit more detail.

How much Process Description is required or needed?

Thank you very much for taking the time to read this! and any help is very welcome

/beastie
 
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Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#3
<snip> I want to work out what processes i specifically need to document and what processes i actually need to complete and then document! <snip>
You are referring to manufacturing process documentation, correct?
 
D

debeast

#4
Thank you very much for your replies they are much appreciated.
Marc: Its a medical diagnostic software. So i assume its manufacturing of that software yes :)

Arios: It will have to be reading for me due to time constraints. Any idea where i can get the documentation you refer to?

Thanks again

Karma to both of you

/beastie
 

Peter Selvey

Staff member
Super Moderator
#6
Just some experience here: the best thing you can do now is to schedule an audit - a real audit, not a dummy audit. One that you are paying money for and will hurt if you fail.

Why? Quality systems and regulatory documents are daunting because there are many open ended requirements. You can type forever and still not comply (have you ever seen a design input specification that is "complete and unambiguous"? It's impossible but necessary to comply with ISO 13485!)

The deadline helps to focus and prioritise. Make sure every time the standard says you need a procedure or record, always have something in place for the auditor to see. Then focus on the critical areas for your product, such as verification and validation of the software's interpretation function, control of software revisions during the design process and distribution.

For Europe, and especially this being a software product, make sure your quality system includes appropriate requirements from EN 62304. You will find this standard will compliment ISO 13485 in many ways (although at first it can also can be overwhelming).
 
D

debeast

#7
Thank you for the help !!!

In your experience is is good to get an external consulting company in to assist with the documentation needed?

Obviously knowing the requirements myself will be of benefit, but i expect i will need the expertise of someone familiar with the process :)

What are your views?

thanks

/beastie
 

Peter Selvey

Staff member
Super Moderator
#8
Probably a good idea if you are starting from scratch. A consultant may have a template quality manual, procedures and forms, and can help explain typical implementation.

But rather than modifying the templates (if they have them), I would strongly recommend just to use them as a guide and start again.

One reason is it's unlikely that they will have a template for a software company, and there are many things which are not applicable or significant. Second is that modifying a template runs the risk of leaving in requirements that you don't do in practice. Third is simply format: modifying someone else's docs always ends up messy with fonts, alignments and tables, better to start again on your own company format and PCs.
 
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