Transitioning from ISO 9001:2008 to ISO 13485?

NikkiQSM

Quite Involved in Discussions
#1
Hello All -

Is there a "check sheet" if you will, on what is needed to transition to 13485 from 9001:2008?

Yes I own a copy of both standards, and yes I have reviewed the Annex B portion of 13485 that explains the difference between the two. But I was hoping for something short, sweet, and right to the point, in simple English.

I've been working pretty hard on changing our Quality Manual over, I have written SOP's for Work Environment, Risk Management, Validating Computer Software, How to Handle Product with Short Shelf-Life, How to Use Advisory Notices... These are amoung the many already in place due to the requirements of the 9001 Standard.

But my luck being the way it is, I would go through my registrar audit and seem to miss one cruical thing.

So is there such thing as a cheat sheet for this process, or am I just gonna have to buckle down and read the standard, my procedures, my documents, and my quality manual over and over and over again, until its completely ingrained in my brain?:confused:
 
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sagai

Quite Involved in Discussions
#4
hmmmmm ...
I would propose first to establish higher level maturity and awareness of the quality level expected in the medical industry for the people you work with, than jump into the business of writing SOPs.
Regards
 
#5
By "transitioning" do you mean that you are incorporating ISO 13485 into your existing QMS (combined ISO 9001 and ISO 13485 registrations) or are you only going to be registered to ISO 13485? Annex and TR 14969 work well.

Something else to think about is if you are planning on doing domestic manufacturing and or distribution, you will also need to have you QMS complient to FDA 21CFR Part 820 for medical devices. Yes, more work.
 

Wes Bucey

Quite Involved in Discussions
#6
Hello All -

Is there a "check sheet" if you will, on what is needed to transition to 13485 from 9001:2008?

Yes I own a copy of both standards, and yes I have reviewed the Annex B portion of 13485 that explains the difference between the two. But I was hoping for something short, sweet, and right to the point, in simple English.

I've been working pretty hard on changing our Quality Manual over, I have written SOP's for Work Environment, Risk Management, Validating Computer Software, How to Handle Product with Short Shelf-Life, How to Use Advisory Notices... These are amoung the many already in place due to the requirements of the 9001 Standard.

But my luck being the way it is, I would go through my registrar audit and seem to miss one cruical thing.

So is there such thing as a cheat sheet for this process, or am I just gonna have to buckle down and read the standard, my procedures, my documents, and my quality manual over and over and over again, until its completely ingrained in my brain?:confused:
I see by your Cove Profile you have a relatively small organization. Please don't over think this situation and get yourself bogged down in writing and rewriting documents - unless you are also changing your actual operations. Most consultants in this field find that the organizations switching to 13485 are doing this for the marketing purpose of expanding markets to countries and organizations which are part of the "harmonization" facet of 13485. Given this aspect, my point would be to be certain the registrar you select is approved in the markets you seek to enter.

As previous posts indicate, Annex B is pretty much as simple as it gets. If you are really stressed, think about hiring a consultant to perform a desk audit of your documentation and perform the gap analysis of your current documentation (especially if you are already registered to 9001.) The desk audit probably does not require a site visit, just a transfer of your documents by email or FTP.

You will most likely be pleasantly surprised that most of your current documents are just fine as is. (Also, think of the downside of having to acquaint your staff with NEW documents!)
 
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