ISO13485 Documentation packs (manual, procedures, forms etc)

[MarkySan]

Hello folks,

Just wondered if anyone has bought and used any of the documentation packs you can buy from various sources to aid the certification process? They seem to vary significantly in price as well, but more importantly are they any good?

I can see the positives and negatives in this approach. However, just wondered what peoples actual experience are of them?

Thanks

 

[silverjlp]

Hi,
Can you be a bit more specific? What types of documentation? What types of certifications? Are you talking equipment, processes, calibration......

I need more information.

Thanks!!

 

[AndyN]

Hello folks,

Just wondered if anyone has bought and used any of the documentation packs you can buy from various sources to aid the certification process? They seem to vary significantly in price as well, but more importantly are they any good?

I can see the positives and negatives in this approach. However, just wondered what peoples actual experience are of them?

Thanks

I recently "stumbled" over such a pack and it was rubbish. For example, the so-called "level 2" procedure for product design and development was simply a restatement of the ISO 13485 design requirements!

 

[Mark Meer]

Just wondered if anyone has bought and used any of the documentation packs you can buy from various sources to aid the certification process? They seem to vary significantly in price as well, but more importantly are they any good? ...

At best, these serve as a "bootstrap" to get a QMS off the ground, but fundamentally you'll need to tailor to your own operations so no out-of-the-box documentation will be sufficient. Unless the cost includes consulting, customization, I'd be very wary of the more expensive "packages".

That said, the organisation I presently work for started with such a system. Everything has since been re-written.

...and I'll second AndyN's observation that a lot of it was just copied directly from ISO13485.

Nevertheless, as a newbie at the time, it was very useful to help me get a sense of how procedures might be organized, what type of records/data is collected, etc. It was a good starting point for someone not previously familiar with quality systems management.