company_profile.yml

version: 2
company:
  legal_name: "ACME GmbH"
  registered_address:
    street: "Paradeplatz 8"
    postal_code: "8001"
    city: "Zurich"
    country: "Switzerland"
  operating_model: "remote-first"
  regulatory_role: "Manufacturer"
  product_type: "Healthcare software products; some products may qualify as SaMD"
  intended_use_policy: "Each product defines intended use, indications, claims, and regulatory classification before development and release under controlled procedures."
  infrastructure_policy: "Each product defines and approves infrastructure architecture and controls against applicable security, availability, and traceability requirements within the product dossier."
  qms_intent:
    - "Apply ISO 9001 quality management expectations for organization context, interested-party needs, customer focus, process performance, organizational knowledge, and continual improvement."
    - "Ensure consistent compliance with ISO 13485 and applicable regulatory requirements."
    - "Apply IEC 62304 software lifecycle, maintenance, configuration, and problem-resolution controls for regulated software."
    - "Apply ISO 14971 risk management across the software lifecycle, including cybersecurity-related harms."
    - "Apply IEC 62366-1 usability engineering for safety-related user interface design and validation."
    - "Apply IEC 82304-1 product-safety controls for health software products operated on general computing platforms."
    - "Apply ISO/IEC 27001 information security governance for QMS, product, supplier, and operational information assets."
    - "Apply ISO/IEC 42001 AI management controls for AI components inside ACME medical-device software and AI-bearing supplier interfaces, including AI lifecycle, AI risk and impact assessment, and complete Annex A control consideration. Non-product AI tooling used to author or operate the QMS remains controlled under supplier control, QMS tooling validation, document control, and change control unless it becomes part of a released product."
    - "Maintain product safety and performance through controlled lifecycle processes."
    - "Provide objective evidence and full traceability for quality decisions."
quality_policy_statement:
  approved_by_role: "management_representative"
  statement: "ACME GmbH commits to delivering safe and effective healthcare software through a risk-based, evidence-driven quality management system and continuous improvement."
signature_preferences:
  preferred_display_roles:
    aliakseit: "Management Representative"
    inatsitovich: "Quality Assurance Lead"
quality_objective_framework:
  governance_cadence: "quarterly"
  objectives:
    - id: "QO-001"
      objective: "Merge controlled pull requests only after required approval on the current head commit"
      metric: "percent_controlled_prs_meeting_approval_gate"
      target: "100%"
    - id: "QO-002"
      objective: "Release only baselines with complete V&V, risk, and release traceability evidence"
      metric: "percent_release_baselines_with_complete_traceability_package"
      target: "100%"
    - id: "QO-003"
      objective: "Close critical quality actions on time"
      metric: "percent_critical_quality_actions_closed_on_or_before_due_date"
      target: ">=95%"
    - id: "QO-004"
      objective: "Complete required controlled-document training on time"
      metric: "percent_training_requests_closed_by_due_date"
      target: ">=98%"
    - id: "QO-005"
      objective: "Maintain management review cadence"
      metric: "reviews_completed_per_plan"
      target: "100%"
    - id: "QO-006"
      objective: "Ensure products perform against defined performance criteria and complaint thresholds"
      metric: "percent_active_products_meeting_defined_performance_and_complaint_thresholds"
      target: "100%"
    - id: "QO-007"
      objective: "Maintain information security controls for QMS and product lifecycle evidence"
      metric: "percent_required_isms_reviews_and_risk_treatments_completed_on_time"
      target: ">=95%"
    - id: "QO-008"
      objective: "Maintain AI management controls for AI components inside released medical-device software"
      metric: "percent_required_aims_reviews_and_impact_assessments_completed_on_time"
      target: ">=95%"
    - id: "QO-009"
      objective: "Monitor customer feedback, satisfaction signals, and process performance for improvement opportunities"
      metric: "percent_required_customer_and_process_quality_reviews_completed_on_time"
      target: ">=95%"