In a Medical Device Manufacturer World Why ISO 9001 At All?

fialor

Involved In Discussions
#1
Responding to a post about an integrated QMS for 9001 and 13485 has made me ponder the following:

In light of the continued divergence between ISO 13485 and ISO 9001, why whould a purely medical device company want to maintain compliance to ISO 9001 in their QMS?

My thoughts are: keep it clean (do not dilute it), RA professionals in medical devices have enough to do without the unnecessary requirements being piled on, scare resources can then be focused on the areas that matter.
 
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Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#2
I don't have a copy of ISO 13485, but if its approach to structure is the same as TS 16949 and RC 14001, it already includes all of the ISO 9001 clauses. So separate certification would be non-value added.
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#3
In light of the continued divergence between ISO 13485 and ISO 9001, why would a purely medical device company want to maintain compliance to ISO 9001 in their QMS?
Most companies having to maintain "multiple" certifications are 2nd or 3rd level suppliers such as machine shops or assembly/contract manufacturers that provide services and products to a variety of customers in different sectors..

For a "purely medical device" organization to maintain compliance with and certification to ISO 9001 makes so little sense that their leadership heads should be examined for concussion signs.
 
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