dearauditor-qms-baseline/matrices/iec_62366_1_gap_analysis.yml at main · AliakseiT/dearauditor-qms-baseline · GitHub

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version: 1
analysis_date: "2026-03-05"
standard:
  exact_name: "EVS-EN 62366-1:2015+A1:2020 Medical devices - Part 1: Application of usability engineering to medical devices"
  normative_base: "IEC 62366-1:2015+A1:2020"
analysis_scope: "ACME GmbH DearAuditor QMS baseline usability engineering process for user-facing SaMD"
summary:
  implementation_model: "Lightweight Git-native usability engineering file in designated product/study repositories with direct risk linkage"
  outstanding_gaps: []
clause_to_artifact_map:
  "4.1.1": ["SOP-019"]
  "4.1.2": ["SOP-019", "SOP-018"]
  "4.1.3": ["SOP-019"]
  "4.2": ["SOP-019"]
  "4.3": ["SOP-019"]
  "5.1": ["SOP-019", "<product-or-study-repo>/records/usability/*/use_specification.yml"]
  "5.2": ["SOP-019", "<product-or-study-repo>/records/usability/*/ui_safety_characteristics.yml"]
  "5.3": ["SOP-019", "<product-or-study-repo>/records/usability/*/hazard_related_use_scenarios.yml", "SOP-018"]
  "5.4": ["SOP-019", "<product-or-study-repo>/records/usability/*/hazard_related_use_scenarios.yml"]
  "5.5": ["SOP-019", "<product-or-study-repo>/records/usability/*/summative_evaluation_record.yml"]
  "5.6": ["SOP-019", "<product-or-study-repo>/records/usability/*/ui_safety_characteristics.yml"]
  "5.7.1": ["SOP-019", "<product-or-study-repo>/records/usability/*/summative_evaluation_record.yml"]
  "5.7.2": ["SOP-019", "<product-or-study-repo>/records/usability/*/formative_evaluation_log.yml"]
  "5.7.3": ["SOP-019", "<product-or-study-repo>/records/usability/*/summative_evaluation_record.yml"]
  "5.8": ["SOP-019", "<product-or-study-repo>/records/usability/*/formative_evaluation_log.yml"]
  "5.9": ["SOP-019", "<product-or-study-repo>/records/usability/*/summative_evaluation_record.yml"]
  "5.10": ["SOP-019", "<product-or-study-repo>/records/usability/*/uoup_evaluation.yml"]
notes:
  - "Mapping based on provided 62366 mapping dataset and IEC 62366-1:2015+A1:2020 clause structure."
  - "No copyrighted standard text is included; only clause references and implementation decisions."
  - "The upstream baseline stores governance SOPs and matrices; usability execution records are maintained in designated product/study repositories."