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Downscaling from ISO 13485 to ISO 9001

F

Fearghail

#1
I'm not very familiar with 9001 but have done three 13485 certifications. The organization I'm currently working with wants only one of its business lines to fulfill the 13485 requirements and the rest 9001.

My understanding is that if you fulfill the 13485 requirements, you get 9001 almost automatically. But to minimize the work and avoiding to go into details, what are the major parts I can leave out from 13485 to still get 9001?
 
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somashekar

Staff member
Super Moderator
#2
Re: Downscaling 13485 to 9001

If you have purchased the electronic version of the 13485, what you will see in blue italics is the 13485 specific requirements. The rest is ISO 9001.
 

Ronen E

Problem Solver
Staff member
Moderator
#5
Re: Downscaling 13485 to 9001

If you have purchased the electronic version of the 13485, what you will see in blue italics is the 13485 specific requirements. The rest is ISO 9001.
There's also a whole annex in ISO 13485:2003 that compares and explains the differences relative to ISO 9001:2000 (annex B).
 
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