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ISO 13485 QMS software and Audit Checklist

Quality managers use ISO 13485 audit checklist to determine if the QMS aligns with the ISO 13485 software standard requirements. The ISO 13485 audit checklist is used for internal audit while preparing the system for a third-party ISO 13485 certification audit. The ISO 13485 audit checklist allows quality managers to document evidence of compliance based on processes, standard requirements, and process characteristics

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