iec_62304_gap_analysis.yml

version: 1
analysis_date: "2026-03-06"
standard:
  exact_name: "IEC 62304:2006+A1:2015 Medical device software - Software life cycle processes"
  normative_base: "IEC 62304:2006+A1:2015"
analysis_scope: "ACME GmbH DearAuditor QMS baseline governance, templates, and GitHub-native release controls"
summary:
  covered_clause_groups:
    - "4"
    - "5"
    - "6"
    - "7"
    - "8"
    - "9"
  product_specific_or_tailored:
    - clause: "5.1.1 software safety classification depth"
      rationale: "Classification is defined per product or subsystem and drives product-level verification depth."
    - clause: "5.8 software integration/system testing detail"
      rationale: "Execution depth and artifact granularity are maintained in designated product repositories using the controlled V&V templates."
  outstanding_gaps: []
clause_to_control_map:
  "4": ["SOP-005", "SOP-020"]
  "5": ["SOP-008", "SOP-020", "WI-001"]
  "6": ["SOP-020", "WI-002"]
  "7": ["SOP-018", "SOP-020"]
  "8": ["SOP-009", "SOP-020", "WI-002"]
  "9": ["SOP-015", "SOP-020", "SOP-012", "SOP-013", "SOP-014"]