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  • Quality Manual
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    • GP-001 Documents and records control
    • GP-002 Quality planning
    • GP-003 Audits
      • ISO 13484
        • Internal Audit
        • BSI Audit
          • 2023 - Stage 1
            • BSI ISO 13485 audit nonconformity report
            • BSI ISO 13485 audit plan
            • BSI ISO 13485 audit report
          • 2024 - Stage 2
          • 2025 - Surveillance
          • 2026 - Surveillance
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      • R-003-001 Audit program 2025-2026
    • GP-004 Vigilance system
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    • GP-018 Infrastructure and facilities
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    • GP-023 Change control management
    • GP-031 Training Data Governance
    • GP-050 Data Protection
    • GP-051 Security violations
    • GP-052 Data Privacy Impact Assessment (DPIA)
    • GP-110 Esquema Nacional de Seguridad
    • GP-200 Remote Data Acquisition in Clinical Investigations
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  • GP-003 Audits
  • ISO 13484
  • BSI Audit
  • 2023 - Stage 1
  • BSI ISO 13485 audit plan

BSI ISO 13485 audit plan

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