Exclusion vs. Outsourcing? What is an "outsourced process?"

[tarheel]

I just had my second surveillance audit to ISO 2000, and out of the blue our auditor told me that due to new definitions, we could no longer exclude the exclusions that we have had in place in our system for a year. Our corporate functions do all our sourcing, purchasing and design work, and we excluded ourselves from these processes in our quality manual. He gave me a draft ISO document (630R) that says any process that affects its ability to provide conforming product cannot be excluded, it must be considered outsourcing. We have zero control over corporate. Has anyone else come up against this roadblock?

 

[howste]

I would agree with what your auditor said, although I wouldn't have thought they would have allowed the exclusions to begin with. You can get a copy of N630R2 (dated today!) at this link:
https://isotc176sc2.elysium-ltd.net/Outsourced.doc

Look at 2.1 - What is an "outsourced process?"

An outsourced process can be performed by a supplier that is totally independent from the organization, or which is part of the same parent organization (e.g. a separate department or division that is not subject to the same quality management system).

The text of 2.3.2 seems to tell you an approach to handle this situation...

b) When the organization does not have the competence to carry out the process itself, and chooses to outsource it.

In this situation the organization has to ensure that the controls proposed by the supplier of the outsourced process are adequate. In some cases it may be necessary to involve external specialists in making this evaluation.

Just show that the corporate functions have adequate controls (are they ISO certified?) and you should be just fine.

 

[Wes Bucey]

I would agree with what your auditor said, although I wouldn't have thought they would have allowed the exclusions to begin with. You can get a copy of N630R2 (dated today!) at this link:
https://isotc176sc2.elysium-ltd.net/Outsourced.doc

Look at 2.1 - What is an "outsourced process?"

The text of 2.3.2 seems to tell you an approach to handle this situation...
Just show that the corporate functions have adequate controls (are they ISO certified?) and you should be just fine.

For the sake of discussion, only. (I'm not sure how well I'd be able to defend the premise, myself.)
In the described case (corporate supplies goods and designs by doing them in-house or purchasing from third parties):
Could this system be considered more like "customer-supplied designs and materials"? In which case, designs and materials need only be controlled once they hit the subsidiary's or division's premises in the same manner as controlling a customer's designs and materials. The actual nitty gritty of payment/credits/debits for these things is not usually considered in a QMS audit.

 

[Raptorwild]

I would agree with what your auditor said, although I wouldn't have thought they would have allowed the exclusions to begin with. You can get a copy of N630R2 (dated today!) at this link:
https://isotc176sc2.elysium-ltd.net/Outsourced.doc

Look at 2.1 - What is an "outsourced process?"

The text of 2.3.2 seems to tell you an approach to handle this situation...
Just show that the corporate functions have adequate controls (are they ISO certified?) and you should be just fine.

Could not this also be stated in some way in the purchasing documentation and the validation of the outsourced product be in the recieving inspection instructions?
Paula

 

[tarheel]

Documentation

Could not this also be stated in some way in the purchasing documentation and the validation of the outsourced product be in the recieving inspection instructions?
Paula

Thats part of the problem, we have no purchasing documentation. All vendor related activities are carried out by corporate. Technically, they don't provide us anything, so what is there to validate. The same with prints. They supply and develop the prints, but we don't validate anything, we build what they tell us to build. I guess what ticks me off is that we passed our upgrade audit, and a recertification audit with these exclusions as listed.

 

[howste]

State in your quality manual "purchasing section" that purchasing is outsourced to corporate. State that your method of control is that your corporate offices are ISO 9001 certified.

 

[Raptorwild]

State in your quality manual "purchasing section" that purchasing is outsourced to corporate. State that your method of control is that your corporate offices are ISO 9001 certified.

YEAH, what howste said!
Paula