Own foreign manufacturing facilities declared as sub-contractors

V

Volfhart

#1
Just wondering out loud so I can see how stupid my thought might be.....

Our corporate HQ (registered to ISO 13485 and CE) is in the US which is responsible for all development and design as well as some manufacturing.

Full 13485:2016 responsibilities except for no sterile, implanted or installation.

We have several manufacturing facilities worldwide that we currently have registered (on the same certificate as HQ) and audited by our Registrar per the usual yearly surveillance and recertification audits, and of course, the usual registration and audit fees.

What are the Cons to just declaring those facilities as sub-contractors so they might be subject to only the "sub-contractor" unannounced audit? Can we list them on our ISO certificate as "significant subcontractors" like we do on our CE certificate? How does that affect our homologation work?

Looking to save all those fees when looking at what MDSAP is going to cost.

Thoughts of my respected colleagues on this site would be appreciated.
 
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Statistical Steven

Statistician
Staff member
Super Moderator
#2
If they are subcontractors (suppliers), they would need their own QMS separate from the HQ. There are pluses and minuses, some are regulatory, others are risk based. I am not a fan of a single global QMS because complaints, recalls and supplier controls are too complex.


Just wondering out loud so I can see how stupid my thought might be.....

Our corporate HQ (registered to ISO 13485 and CE) is in the US which is responsible for all development and design as well as some manufacturing.

Full 13485:2016 responsibilities except for no sterile, implanted or installation.

We have several manufacturing facilities worldwide that we currently have registered (on the same certificate as HQ) and audited by our Registrar per the usual yearly surveillance and recertification audits, and of course, the usual registration and audit fees.

What are the Cons to just declaring those facilities as sub-contractors so they might be subject to only the "sub-contractor" unannounced audit? Can we list them on our ISO certificate as "significant subcontractors" like we do on our CE certificate? How does that affect our homologation work?

Looking to save all those fees when looking at what MDSAP is going to cost.

Thoughts of my respected colleagues on this site would be appreciated.
 
V

Volfhart

#3
That was my understanding as well when management asked me to look into it. Don't think they wanted to believe what I told them. :rolleyes: Appreciate the confirmation.
 

shimonv

Trusted Information Resource
#4
I agree with Steven. A QMS is like a tailor made suit designed for a specific person and occasion. I have not seen, and this is based on my experience, a corporate QMS that works well for all of its subsidiaries. It's usually a nightmare from an auditing prospective.

On the other hand, you don't want to a have a fragmented organisation. Usually, the best results are somewhere in between.

-Shimon
 

Ronen E

Problem Solver
Staff member
Moderator
#5
If you treat them as suppliers they'll also have to go through supplier evaluation and qualification, and probably through ongoing supplier monitoring audits (by HQ).
 

somashekar

Staff member
Super Moderator
#6
Just wondering out loud so I can see how stupid my thought might be.....

Our corporate HQ (registered to ISO 13485 and CE) is in the US which is responsible for all development and design as well as some manufacturing.

Full 13485:2016 responsibilities except for no sterile, implanted or installation.

We have several manufacturing facilities worldwide that we currently have registered (on the same certificate as HQ) and audited by our Registrar per the usual yearly surveillance and recertification audits, and of course, the usual registration and audit fees.

What are the Cons to just declaring those facilities as sub-contractors so they might be subject to only the "sub-contractor" unannounced audit? Can we list them on our ISO certificate as "significant subcontractors" like we do on our CE certificate? How does that affect our homologation work?

Looking to save all those fees when looking at what MDSAP is going to cost.

Thoughts of my respected colleagues on this site would be appreciated.
If your ISO 13485 CB and your CE NB are the same corporation, then you need not do much changes except define them accordingly in your system documentation. The best is to consult with your CB/NB.
 
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