Supplier qualification checklist

The depth of qualification matches the impact of the supplied item on product quality and patient safety — a critical API supplier warrants an audit; a low-risk consumable may justify certificate review only. The checklist's first rows force that classification and its rationale onto the record.

No — the route (audit, questionnaire, certificate review) should follow the risk classification, and the justification for the chosen route should be documented. Unjustified questionnaire-only qualification of critical suppliers is a common finding.

Responsibility allocation, specification and change notification duties, audit rights, and complaint/deviation communication — agreed before supply starts. The checklist treats the agreement as an approval-stage requirement, not an afterthought.