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?
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?