ISO 13485 for Metal Finishing

#1
This question goes to all Med Device Contract Manufacturers. What advantages do I have as a Metal Finisher for attaining a 13485 Cert? After my evaluation once we exclude the provisions that are not meant for the Contract Manufacturer all you have left is a stripped down version of ISO 9001. so why would any metal finisher get a 13485 certification? can anyone lend insight to me?
 
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pziemlewicz

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#2
IMO, you have no reason to be 13485 as you will never supply a finished device. Stick with the easier/cheaper ISO. If you want to go above and beyond, look into NADCAP certification for the processes you provide.
 

pziemlewicz

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#4
What about being able to do finishing on Med device classes 2 and 3? would you stay with your current comment?
Yes (assuming US since this was posted in FDA section). The customer should require validation of your process (OQ/PQ), however vendor certification is not a requirement of the standard.

The caveat being that device manufacturers need to have a method to manage supplier risk; in some cases, they choose to do this by requiring vendors to be 13485 certified.
 

Sidney Vianna

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#6
so why would any metal finisher get a 13485 certification? can anyone lend insight to me?
If voluntary, the only reason I can see is perceived marketability towards medical device manufacturers. In addition to the drawbacks you mentioned, the cost of certification would be significantly higher and the availability of auditors much tighter.
 
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