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: Any software used within the QMS (such as ERP systems or eQMS platforms) or production lines must be validated for its intended use before implementation. iso 13485 2016 a practical guide pdf full

Identify and document every process within your operations, from purchasing to product delivery. Establish how these processes interact. as these often contain outdated versions

Define competency requirements for every role. Maintain robust training records, and critically evaluate the effectiveness of training programs rather than just logging attendance. iso 13485 2016 a practical guide pdf full