00007 REV01 Scope of QMS

Per ISO 13485:2016 section 4.2.2, Quality manual: “The organization shall document a quality manual that includes: a) the scope of the quality management system, including details of and justification for any exclusion or non-application” This figure is designed to convey the decisions needed to state what is in and out of scope of the QMS and what activities are non-applicable or are exclusions.