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QMS
  • Welcome to your QMS
  • Quality Manual
  • Procedures
  • Records
    • GP-001 Documents and records control
    • GP-002 Quality planning
    • GP-003 Audits
      • 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
      • Deprecated
      • R-003-001 Audit program
    • GP-004 Vigilance system
    • GP-005 HR and training
    • GP-007 Post-market surveillance
    • GP-009 Sales
    • GP-010 Suppliers
    • 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
  • TF_Legit.Health_Plus
  • Licenses and accreditations
  • External documentation
  • Records
  • GP-003 Audits
  • 202402 Stage 2 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

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BSI ISO 13485 audit report
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BSI ISO 13485 audit plan
All the information contained in this QMS is confidential. The recipient agrees not to transmit or reproduce the information, neither by himself nor by third parties, through whichever means, without obtaining the prior written permission of Legit.Health (AI LABS GROUP S.L.)