ISO 13485:2016
Management responsibility – ISO 13485:2016

ISO 13485:2016 5.5.2: Management representative

Top management appoints a member of management who, whatever other responsibilities they hold, has responsibility and authority for ensuring the processes needed for the quality management system are documented, reporting to top management on the effectiveness of the system and any need for improvement, and ensuring awareness of applicable regulatory requirements and quality management system requirements is promoted throughout the organization.

Maintained by Gerard BlokdykControl text last updated

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