9001:2000 now states "Where an organization chooses to outsource any process that affects product conformity with requirements, the organization shall ensure control over such processes. Control of such outsourced processes shall be identified within the quality management system."

My company outsourced its manufacturing three years ago. Beyond the initial training and surveillance, our quality system includes quality plans, review of quality records, and management of change control. Further, there are periodic assessments of their quality system, originally through full quality audits and most recently through a review of their ISO audits and corrective actions.

I would appreciate feedback as to whether these items constitute sufficient control over the outsourced operations.

One specific question: should inspection checklists generated by the subcontractor and used for final inspection be approved by us each time they are revised?

Opinions appreciated.

I don't see why there would be a problem with what you're doing. I think it's pretty common practice to accept an ISO certification as control of outsourced processes. If you have a good relation with them and haven't had problems that's indication of control as well. You're reactions to any problems are also indications as well. From most people I've talked to this is a pretty loose requirement. As long as you're not continuing to use someone who constantly sends you bad product you should be fine :vfunny:

As to the revisions to the checklists, are they revised based on specifications that you provide? If that's the case I wouldn't really worry about it. We have a number of customers that provide us with different criteria which we then 'translate' into our format, but everything is still based on what they provide.

The standard does not state how much or how little control you put on the outsource supplier. That is up to you to show. If you don't have problems then you don't need to show strict control and so on.
The only concern I would have with the checklist is if it changes a Control Plan that you have approved. And even in that circumstance it may only require notification to you and not a sign off or approval.

A warrior goddess of quality, and I thought my life was complete when I got to meet Joan Jett!!!!:biglaugh:

I would ask
"If I am satisfied with my outsourcing product Quality, do I need to approve control plan or try to improve his control plan."

A warrior goddess of quality, and I thought my life was complete when I got to meet Joan Jett!!!!

Hey, ya gotta do something to make this job fun! I bet Joan Jett would wilt in a week if she had to do what we do every day!:p