ISO13485 Standard Documentation Packages

#1
Hi all,

I am looking into implementing a ISO13485 quality management system for our small company (4 people)
as we have very limited experience with setting up such a system, i have been exploring purchasing possible "standard documentation packs" to kickstart the process.

So far, i'm finding very mixed responses online on whether such standard packages are helpful.
I was wondering if people could share their experiences using standard documents, and perhaps recommend certain package when this experience was positive.

Thanks very much!
 
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James

Involved In Discussions
#2
Hi all,

I am looking into implementing a ISO13485 quality management system for our small company (4 people)
as we have very limited experience with setting up such a system, i have been exploring purchasing possible "standard documentation packs" to kickstart the process.

So far, i'm finding very mixed responses online on whether such standard packages are helpful.
I was wondering if people could share their experiences using standard documents, and perhaps recommend certain package when this experience was positive.

Thanks very much!
I used a standard package for 9001 years ago. It gave me a good understanding of how to structure a system, but in practical terms it was useless; \I had to re-write everything.

Finding a mentor to guide you through setting up your own system in a way that works for your products / company might be a better use of your money in my view. Obviously your regulatory context / risk class etc wont be reflected well in standard packages

Good luck!
 

Gisly

Starting to get Involved
#3
My experience is that the standard packages more or less replicates the standards itself. It could give you a framework but one should be very careful to try to follow a generic process - it will often be ambiguous and/or meaningless.

And as stated by James, the purpose of implementing the ISO13485 should be clarified - what is your product(s) risk classification, what is the SCOPE of your QMS as you may not do any Design and Development activities? And lastly, are you currently or planning to comply with other standards such as ISO27001, 80002-2, 14971, 62304, .... The list is endless but all will set forth requirements for processes and documentation.
 
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