ISO 13485:2016
Quality management system – ISO 13485:2016

ISO 13485:2016 4.2.2: Quality manual

The organization documents a quality manual that states the scope of the quality management system, including details of and justification for any exclusion or non-application, contains or references the documented procedures, and describes the interaction between the processes of the system. The manual outlines the structure of the documentation used in the system.

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