R
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.
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.