ISO13485 - 4.2.2 Quality manual

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4.2.2 Quality manual

The organization shall establish and maintain a quality manual that includes a) the scope of the quality management system, including details of and justification for any exclusion and/or non-application (see 1.2), b) the documented procedures established for the quality management system, or reference to them, and c) a description of the interaction between the processes of the quality management system.

The Quality Manual shall outline the structure of the documentation used in the quality management system

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