This ISO 13485 audit checklist helps medical device organizations evaluate the readiness and compliance of their quality management system against ISO 13485:2016. It covers management controls, quality policy and objectives, internal audits, and management review. The checklist also guides design and development controls, risk management, verification and validation, and design transfer. It includes robust CAPA and complaint handling, MDR reporting, production and process controls, supplier and purchasing controls, and sterilization validation. Documentation and records requirements, DMR, DHR, technical files, customer requirements, and traceability are addressed to support certification preparation.
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