ISO 13485:2016
Management responsibility – ISO 13485:2016

ISO 13485:2016 5.4.2: Quality management system planning

Top management makes sure the quality management system is planned so that it satisfies the general requirements in 4.1 and the quality objectives, and that the system stays intact when changes to it are planned and made.

Maintained by Gerard BlokdykControl text last updated

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  • IEC62304-4.1 Quality Management System

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