Quality Manual Template for ISO 13485 - Small Contract Medical Device Manufacturer

F

fish slayer

#1
Hello,

I am looking for a "good" Quality Manual Template that matches up with ISO 13485. We are a small contract manufacture to the medical industry.

Thanks
 
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2

20130523

#2
Re: Quality Manual Template for ISO 13485

That would be difficult to provide, becasue each quality manual really should be targeted at how that specific company runs. But, if you are looking for a checklist of items to include in your quality manual, here is a cool document: http://ts.nist.gov/WeightsAndMeasures/upload/ir7028all.pdf Check out page 9 and 10, it is a clear table of contents. I don't have my manual set up the same way, but it includes a lot of the components.

My advice? Include flowcharts of key procceses and committees in your company, and don't forget to clearly call out your exclusions from section 7.

Good Luck.
 
G

George Weiss

#3
Re: Quality Manual Template for ISO 13485

A template is maybe hard to find. An example is not.
You sound as if a look at some examples is the request.
Reviewing a wheel that is already rolling is a good plan.
A 34 page example @
http://www.nitinol.com/media/files/NDC-Quality-Manual.pdf
A 12 page preview partial example @
http://www.quality-works.com/download/iso-13485-2003-9001-2008-qm-preview.pdf
A 17 page example @
http://www.jademed.com/pdf/QM-42-001%20A%20Quality%20Manual.pdf
With a little review, your manual should look strikingly like these.
I am suggesting you will need a bunch of support procedures also.
a 13485 reference document @
http://elsmar.com/Forums/fileslist.php?mode=allfiles&sortby=filename&pageamt=1&criteria=13485
 
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