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ISO9001 and ISO 13485 Relationship? Can we do both effectively?

C

CHPegasus

#1
#1
I am in the process of ISO9001 (getting starting with the requirements), and we've just had a new client ask us to also become 13485 certified. In my hasty research, it seems that 9001 & 13485 are related/very similar, but 9001 is much stricter. Anyone have info or experience with doing both at the same time?

Thank you!!
 
QMS for Medical Device Companies
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Randy

Randy

Super Moderator
#2
#2
You've got it backwards, 13485 is more stringent (9001 is contained within 13485 so it goes beyond similar) and yes they get along well, just ask any one of the few thousand other orgainzations that have done it
 
C

CHPegasus

#3
#3
Ah! So if I follow 13485, I ought to be able to also certify 9001?

Thanks!!
-Brain Fried from technical reading! :bonk:
 
A

AndyN

Moved On
#5
#5
CHPegasus said:
Ah! So if I follow 13485, I ought to be able to also certify 9001?

Thanks!!
-Brain Fried from technical reading! :bonk:
Click to expand...
Yes! Since they aren't 1-for-1 comparable - for example Continuous Improvement is different between the 2 - you will have to make adjustments in your QMS and you can be registered and have 2 certificates.
 
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