Use this supply chain department audit checklist to assess and qualify medical device suppliers. Verify documentation such as ISO 13485/ISO 9001 and CE or 510k certificates, quality agreements, audit plans and records, COC/COA, MSDS, and biocompatibility. Include checks for cleanroom or environmental reports, sterilization compliance like ISO 11135, and measurement lab credentials (CNAS/CMA). Strengthen compliance, traceability, and procurement controls.
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