{
  "name": "Article 17 QMS Template Pack",
  "version": "1.0.0",
  "description": "EU AI Act Quality Management System template for high-risk AI systems",
  "regulation": "EU AI Act (Regulation 2024/1689) Article 17",
  "disclaimer": "Fictional sample for educational purposes. Not legal advice.",
  "structure": {
    "01-QMS-Manual": {
      "description": "Main policy document establishing the QMS framework",
      "documents": [
        {
          "id": "QMS-MAN-001",
          "filename": "QMS-Manual-Article17.md",
          "title": "Quality Management System Manual",
          "description": "Comprehensive QMS manual covering all 13 elements (a-m) of Article 17(1)"
        }
      ]
    },
    "02-Procedures": {
      "description": "Core procedures for QMS operation",
      "documents": [
        {
          "id": "QMS-PRO-001",
          "filename": "QMS-PRO-001-Change-Control.md",
          "title": "Change Control Procedure",
          "covers": ["Element (a): Change and modification management"]
        },
        {
          "id": "QMS-PRO-006",
          "filename": "QMS-PRO-006-Data-Management.md",
          "title": "Data Management Procedure",
          "covers": ["Element (f): Data governance across the lifecycle"]
        },
        {
          "id": "QMS-PRO-007",
          "filename": "QMS-PRO-007-Risk-Management.md",
          "title": "Risk Management Procedure",
          "covers": ["Element (g): Risk management system integration"]
        },
        {
          "id": "QMS-PRO-008",
          "filename": "QMS-PRO-008-Post-Market-Monitoring.md",
          "title": "Post-Market Monitoring Procedure",
          "covers": ["Element (h): Monitoring after deployment"]
        },
        {
          "id": "QMS-PRO-009",
          "filename": "QMS-PRO-009-Incident-Reporting.md",
          "title": "Incident Reporting Procedure",
          "covers": ["Element (i): Serious incident reporting"]
        }
      ]
    },
    "03-Records-Forms": {
      "description": "Templates for required operational records",
      "documents": [
        {
          "id": "QMS-REC-001",
          "filename": "QMS-REC-001-Internal-Audit-Report.md",
          "title": "Internal Audit Report",
          "purpose": "Document internal audit findings"
        },
        {
          "id": "QMS-REC-002",
          "filename": "QMS-REC-002-Management-Review-Minutes.md",
          "title": "Management Review Minutes",
          "purpose": "Record management review meetings"
        },
        {
          "id": "QMS-REC-003",
          "filename": "QMS-REC-003-CAPA-Log.md",
          "title": "CAPA Log",
          "purpose": "Track corrective and preventive actions"
        },
        {
          "id": "QMS-REC-004",
          "filename": "QMS-REC-004-Change-Request-Form.md",
          "title": "Change Request Form",
          "purpose": "Initiate and track changes"
        },
        {
          "id": "QMS-REC-005",
          "filename": "QMS-REC-005-Incident-Report-Form.md",
          "title": "Incident Report Form",
          "purpose": "Document and investigate incidents"
        }
      ]
    },
    "04-Evidence-Templates": {
      "description": "Templates for evidence packaging and audit readiness",
      "documents": [
        {
          "id": "EVD-TPL-001",
          "filename": "Evidence-Manifest-Template.md",
          "title": "Evidence Manifest Template",
          "purpose": "Package evidence with integrity verification"
        }
      ]
    }
  },
  "article17Elements": [
    {
      "element": "a",
      "title": "Regulatory compliance strategy + change management",
      "coverage": ["QMS Manual §3.1", "QMS-PRO-001"]
    },
    {
      "element": "b",
      "title": "Design control + design verification",
      "coverage": ["QMS Manual §3.2"]
    },
    {
      "element": "c",
      "title": "Development + QA controls",
      "coverage": ["QMS Manual §3.3"]
    },
    {
      "element": "d",
      "title": "Test + validation procedures",
      "coverage": ["QMS Manual §3.4"]
    },
    {
      "element": "e",
      "title": "Technical specs + standards",
      "coverage": ["QMS Manual §3.5"]
    },
    {
      "element": "f",
      "title": "Data management",
      "coverage": ["QMS Manual §3.6", "QMS-PRO-006"]
    },
    {
      "element": "g",
      "title": "Risk management integration",
      "coverage": ["QMS Manual §3.7", "QMS-PRO-007"]
    },
    {
      "element": "h",
      "title": "Post-market monitoring",
      "coverage": ["QMS Manual §3.8", "QMS-PRO-008"]
    },
    {
      "element": "i",
      "title": "Serious incident reporting",
      "coverage": ["QMS Manual §3.9", "QMS-PRO-009"]
    },
    {
      "element": "j",
      "title": "Communication procedures",
      "coverage": ["QMS Manual §3.10"]
    },
    {
      "element": "k",
      "title": "Record-keeping",
      "coverage": ["QMS Manual §3.11", "All record templates"]
    },
    {
      "element": "l",
      "title": "Resource + supply management",
      "coverage": ["QMS Manual §3.12"]
    },
    {
      "element": "m",
      "title": "Accountability framework",
      "coverage": ["QMS Manual §2.2", "QMS Manual §3.13"]
    }
  ],
  "relatedStandards": [
    {
      "id": "prEN 18286",
      "title": "Artificial Intelligence - Quality Management System for EU AI Act Regulatory Purposes",
      "status": "Draft"
    },
    {
      "id": "ISO/IEC 42001:2023",
      "title": "AI Management System",
      "status": "Published"
    },
    {
      "id": "ISO/IEC 23894:2023",
      "title": "AI Risk Management",
      "status": "Published"
    }
  ],
  "resources": {
    "euAiAct": "https://eur-lex.europa.eu/eli/reg/2024/1689/oj",
    "standardisation": "https://digital-strategy.ec.europa.eu/en/policies/ai-act-standardisation"
  }
}