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  • Welcome to your QMS
  • Quality Manual
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    • GP-001 Documents and records control
    • GP-002 Quality planning
    • GP-003 Audits
      • ISO 13484
        • 202309 Internal audit
        • 202311 Stage 1 ISO 13485 BSI audit
        • 202402 Stage 2 ISO 13485 BSI audit
          • BSI ISO 13485 audit plan
          • BSI ISO 13485 audit report
          • BSI ISO 13485 Corrective action plan
        • 202409 Internal audit
        • 202501 ISO 13485 BSI surveillance audit
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      • R-003-001 Audit program
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    • GP-005 HR and training
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    • GP-012 Design, Redesign and Development
    • GP-018 Infrastructure and facilities
    • GP-019 Software validation
    • GP-023 Change control management
    • GP-050 Data Protection
    • GP-051 Security violations
    • GP-052 Data Privacy Impact Assessment (DPIA)
    • GP-200 Remote Data Acquisition in Clinical Investigations
    • GP-011 Provision of service
    • GP-110 Esquema Nacional de Seguridad
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  • GP-003 Audits
  • ISO 13484
  • 202402 Stage 2 ISO 13485 BSI audit
  • BSI ISO 13485 audit plan

BSI ISO 13485 audit plan

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202402 Stage 2 ISO 13485 BSI audit
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BSI ISO 13485 audit report
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