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TE Subcontractor Development

J

JPeyton

#1
#1
Per TE Supplement 4.6.2.1
"Subcontractor Development shall use the TE Supplement as a fundamental quality system requirement".

How do you do this?
The Auditors want to see proof of development and what do you do if all of your subcontractors are already certified?
 
QMS for Medical Device Companies
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T

Tom Goetzinger

#2
#2
We are surveying all of our production part supplier within the next year to identify if they are certified and if they are not, if they plan on it. This will give us a baseline. We will use our Corrective and Preventitive Action Process to identify which suppliers are causing problems for us in what areas, and try to help them develop processes that will help them and us.
The standard does give you quite a bit of leeway in this element.
If all of your suppliers are certified, I wouldn't worry much about this element.
 
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