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Contracted Manufacturing - We use all contracted manufacturing sites

C

Cari

#1
#1
We are audited to QS9000, but have an ISO 9001 certificate, because we do not own any manufacturing. We use all contracted manufacturing sites. Some of the products we design are required by the customer to be QS compliant. So, we use a QS certified manufacturing facility. However, some of the products we design or not required to be QS compliant. So, can we still use a QS certified manufacturing facility? Or, does this affect their certificate, beacuse they would be manufacturing a design that is only ISO, not QS?
 
QMS for Medical Device Companies
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A

Al Dyer

#2
#2
Cari,

If I read you correctly, the "contracted manufacturer" is your supplier and you define the level of control imposed.

Also, I can't see why a company that is QS-9000 registered would have any problem working with an ISO designed product since they would already have the system in place to define supplier and customer requirements.

Hope this helps.

Any other insights from the forum?

ASD...

[This message has been edited by Al Dyer (edited 21 January 2001).]
 
Marc

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#3
#3
Right, Al. There is no reason a QS facility cannot manufacture (assemble, whatever) an ISO (or a non-iso) product. Registration does not imply or require exclusion.
 
F

freeda

#4
#4
We are a QS registered manufacturing company that produces both automotive parts and non-automotive parts. Our procedures/systems do not distinguish a QS part from an ISO part. The systems we have in place are the same for both. So your contracted QS company can produce both QS and ISO parts, as long as they are compliant with their procedures.
 
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