Supplier Qualification for Engineering Consultant?

kchan

Starting to get Involved
#1
We are a medical device company.
We are considering hiring an engineering consultant to design part of our upcoming products.
Do they need to undergo a supplier qualification? They are not affecting our quality system, and our own employee would be the responsible engineer releasing the part into our Document Control System.
Can we simply have the consulting company/person's resume on file?
 
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yodon

Staff member
Super Moderator
#3
These 2 statements would seem contradictory:
We are considering hiring an engineering consultant to design part of our upcoming products.
and
They are not affecting our quality system
Irrespective of the requirements in the standard, I'm *sure* you're vetting the candidate (thus qualifying and approving). What were the qualifications required for the engineer? (Those are your approval criteria.) Do you have evidence the candidate met those criteria (possibly in the resume)? I presume you'll monitor the engineer's performance (supplier monitoring) and take appropriate actions if they are not performing as expected. In other words, you're probably already doing what's expected by the standard, you just need to close the loop.
 

Tagin

Trusted Information Resource
#4
There would be supplier qualification, and perhaps also - assuming 13485:2016 - clause 7.3.2f:

During design and development planning, the organization shall document:
f) the resources needed, including necessary competence of personnel
 
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