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Does Outsource of Processes refer to things like heat treat of the product?

G

GARY MOORE - 2009

#1
#1
outsource of processes

Does outsource of processes mean product? Such as sending product out for heat treat, plating, etc. or functions such as
purchasing, HR, accounting.
 
QMS for Medical Device Companies
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M

M Greenaway

#2
#2
Gary

It could be applied to any process, but I would think a company would be most interested in the processes relating directly to the product.
 
M

Mike S.

Happy to be Alive
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#3
#3
Jim said "the 'standard' requires us only to worry about outsourced process that affect product conformity with requirements but are NOT product realisation processes."

I'm having a brain timeout. Which processes affect product conformity but are not product realization processes?
 
D

db

#4
#4
controlling outsourced processes

So it would appear that - even though what Martin says makes IMO sound common sense - that the 'standard' requires us only to worry about outsourced process that affect product conformity with requirements but are NOT product realisation processes.
Click to expand...
Go back even further. clause 1: Scope says:
"...requirements for a quality management system where an organization
a) needs to demonstrate its ability to consistently provide product..."

4.1 deals with the processes need for the QMS. The QMS needs to demonstrate its ability to consistently provide product. The processes mentioned in 4.1 include the processes included in clause 7, as well as processed that are not included in clause 7. Any process governed by the QMS that is outsourced (whether it is related to product realization or not) must be controlled.
 
D

db

#5
#5
clause 7.1 says that clause 4.1 deals with processes OTHER than product realisation processes
Click to expand...
Here is what the standard says in 7.1 Planning of product realization:

"...shall be consistent with the requirements of the other processes of the quality management system (see 4.1)."

It does not say that all processes in 4.1 are “other” processes. What is says is to find more information, refer to 4.1. 4.1, then, refers to the processes of the QMS, which takes us back to my previous post. I cannot see where anyone can conclude that 4.1 is only the “other” processes. In fact 4.1 a) specifically points to 1.2. 1.2 specifically mentions Clause 7. Therefore processes in Clause 7 are part of the processes in 4.1. All 7.1 is saying is that if you wish to get a better understanding of the processes that are not part of this Clause, then refer to 4.1.
 
S

shreeniwas

#6
#6
As per definition of Subcontractor in Glossary QS9000, provider of finishing services , production materials, production / service parts is a subcontractor . As such if the services outsorced by you are not finishing services , you need not treat the service provider as a subcontractor from QS point of view (and the subcontractor development , ISO compience etc does not remain mandatory for such service providers). Do you agree with me?
 
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