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A quality manual is not just a requirement in ISO 13485; it helps companies manage their QMS and describe all the important elements in one place. Quality Manual, Policy and Objectives. ISO 13485:2016 Section, Document Section. 4.1.1, 1. 4.1.2, 4. ISO 13485:2016 ”Medical devices – Quality management systems QMS documents in SharePoint – see {D-0015 Instructions, templates and forms}.