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Setting up from scratch - Looking for help (ISO9001 / ISO13485)

W

whelmed

#1
My company is a start-up starting from scratch. We've been working for baout 4 years now, but in the next 2 years the goal is to become ISO 9001/13485 certified.

There are only 4 of us and we are all pretty much flying blind when it comes to ISO Specs.

Is there a DIY guide, or good books that someone can recommend? I've had a lot of experience in companies that are ISO certified in both of these, but never to set it up.

Thanks so much!
 
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TPMB4

Quite Involved in Discussions
#2
Re: Setting up from scratch, looking for help (9001 / 13485)

When I was new to quality role (still a novice) I went down the book route. Got a reasonable book on ISO9001 (well thought it was at the time). I must admit I never really use it now. I guess the best book is the standard itself and this forum. Feel free to ask questions here as it really is a good way to learn, from those who have traveled the path before you.

One good thing is that as a small start up there is unlikely to be an issue with buy-in to the quality thing. Assuming from the small number of people involved you are also top management/boss/owner and everyone is motivated by the project (i.e. the start-up). I imagine it is very exciting times. Good luck.

As far as books go, I think people on here rate an expert with the name Cochrane, could be wrong. Being from the UK I looked at a few ISO books that seem popular on Amazon UK, the likes of Hoyle. I ended up getting another author whose name escapes me. Guess that says a lot about how useful I found that book!!!
 

somashekar

Staff member
Super Moderator
#3
Re: Setting up from scratch, looking for help (9001 / 13485)

My company is a start-up starting from scratch. We've been working for baout 4 years now, but in the next 2 years the goal is to become ISO 9001/13485 certified.

There are only 4 of us and we are all pretty much flying blind when it comes to ISO Specs.

Is there a DIY guide, or good books that someone can recommend? I've had a lot of experience in companies that are ISO certified in both of these, but never to set it up.

Thanks so much!
Four of you perhaps at a higher level of business management sense, and you have the time ahead of you to establish the quality management (9001/13485) ...
What more do you want than the standard itself and this forum ... TPMB4 is spot on.
Getting your scope clearly and correctly and determining the type of your medical device (lets call it classification) and the region where you want it put (The market) so as to understand the regulatory requirement of the potential market and systamatically PLANNING, DOING, CHECKING, and CORRECTING both the product as well as your systems which make the product (Design, Manufacture, Sales, Post market activities) is all that is in the 9001/13485.
For more, ask specific questions and search this forum with good key words.
 

mihzago

Trusted Information Resource
#4
I would recommend any of the guidance documents on implementation of the QMS and Specific processes (e.g. risk management).
This one is very good: PLUS 13485: The ISO 13485 Essentials.
also check out this blog http://medicaldeviceacademy.com/#

Many of the books on ISO spend too much time on philosophy or are too general to be useful.

I recently finished setting up a QMS compliant with QSR/ISO 13485/ CMDR for a 5-person start-up and I'm currently working on another. Feel free to shoot me a message if you have any questions.
 

Marcelo

Inactive Registered Visitor
#5
The best book on ISO quality systems standard in my opinion is the one by David Hoyle: ISO 9000 Quality Systems Handbook - updated for the ISO 9001:2008 standard.
 
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