Outsourced Process also shall be Documented?

[QAMTY]

Hi all

Trying to clarify complaince againts 9001:2008

If I have outsourced process, I know I must have control over them
The mine are Manufactuting, labeling, packing and shipping.
I´ll try to define how to have control, but
even if they are outsourced should I have procedures of this processes?

Thanks in advance

 

[somashekar]

Hi all

Trying to clarify complaince againts 9001:2008

If I have outsourced process, I know I must have control over them
The mine are Manufactuting, labeling, packing and shipping.
I´ll try to define how to have control, but
even if they are outsourced should I have procedures of this processes?

Thanks in advance

NO.
As many process as you outsource, you must have such many types of controls, each different and specific to the outsourced process that meets your requirement. The intent is to bring these defined controls into the QMS, such that these become a system part and can hence be effectively exercised by the responsible managers / officers who have the responsibility to control the outsourced process.
You can have a documented procedure how all these you want to be done., but such a procedure alone is not a control on the processes outsourced.

 

[qusys]

Hi all

Trying to clarify complaince againts 9001:2008

If I have outsourced process, I know I must have control over them
The mine are Manufactuting, labeling, packing and shipping.
I´ll try to define how to have control, but
even if they are outsourced should I have procedures of this processes?

Thanks in advance

I think you shall establish and communicate your customer requirement to your outsourcer.
You should establish a process to validate the procedures that they use for your business purpose as well as a process to coommunicate the change and approve them