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QMSQMS
QMS
  • Welcome to your QMS
  • Quality Manual
  • Procedures
    • GP-001 Control of documents
      • Annex 1 Responsibility matrix
      • Deprecated
      • Templates
        • T-001-001 Control of documents
        • T-001-002 Manufacturer declaration of conformity
        • T-001-005 List of external documents
        • T-001-006 IFU and label validation YYYY_nnn
        • T-001-007 Manufacturer declaration of conformity_MDR
        • T-001-008 _Device name_ label YYYY_nnn
        • T-001-009 Training on procedures of the QMS
      • Specific procedures
    • GP-002 Quality planning
    • GP-003 Audits
    • GP-004 Vigilance system
    • GP-005 Human Resources and Training
    • GP-006 Non-conformity, Corrective and Preventive actions
    • GP-007 Post-market surveillance
    • GP-008 Product requirements
    • GP-009 Sales
    • GP-010 Purchases and suppliers evaluation
    • GP-011 Provision of service
    • GP-012 Design, Redesign and Development
    • GP-013 Risk management
    • GP-014 Feedback and complaints
    • GP-015 Clinical evaluation
    • GP-016 Traceability and identification
    • GP-017 Technical assistance service
    • GP-018 Infrastructure and facilities
    • GP-019 Software validation plan
    • GP-020 QMS Data analysis
    • GP-021 Communications
    • GP-022 Document translation
    • GP-023 Change control management
    • GP-024 Cybersecurity
    • GP-025 Corporate Governance
    • GP-050 Data Protection
    • GP-051 Security violations
    • GP-052 Data Privacy Impact Assessment (DPIA)
    • GP-100 Business Continuity (BCP) and Disaster Recovery plans (DRP)
    • GP-101 Information security
  • Records
  • TF_Legit.Health_Plus
  • Licenses and accreditations
  • External documentation
  • Procedures
  • Records
  • Procedures
  • GP-001 Control of documents
  • Templates

Templates

📄️ T-001-001 Control of documents

- Governed by GP-001 Document and Records Control

📄️ T-001-002 Manufacturer declaration of conformity

AI Labs Group, SL (hereinafter referred to as "us" or "we"), located at Gran VĂ­a 1, BAT Tower, 48001 Bilbao, Bizkaia, Spain, hereby certify under our responsibility that the manufactured product and its version:

📄️ T-001-005 List of external documents

- Governed by GP-001 Document and Records Control

📄️ T-001-006 IFU and label validation YYYY_nnn

- Governed by GP-001 Document and Records Control

📄️ T-001-007 Manufacturer declaration of conformity_MDR

AI Labs Group SL, located at the Street Gran VĂ­a 1, BAT Tower, 48001, Bilbao, Bizkaia (Spain), with SRN ES-MF-000025345, certifies under its responsibility that the manufactured product:

📄️ T-001-008 _Device name_ label YYYY_nnn

Label

📄️ T-001-009 Training on procedures of the QMS

- Governed by GP-001 Control of documents

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T-001-004 Backup integrity verification
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T-001-001 Control of documents
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.)