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QMSQMS
QMS
  • Welcome to your QMS
  • Quality Manual
  • Procedures
    • GP-001 Control of documents
    • 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
      • Templates
        • T-018-001 Infrastructure list and control plan YYYY_nnn
        • T-018-002 Infrastructure and facilities incidents log
      • Specific procedures
    • 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-026 Product requirements for US market
    • GP-027 Product requirements for UK market
    • GP-028 Product requirements for the Brazilian market
    • 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
    • GP-200 Remote Data Acquisition in Clinical Investigations
  • Records
  • TF_Legit.Health_Plus
  • Licenses and accreditations
  • External documentation
  • Procedures
  • GP-018 Infrastructure and facilities
  • Templates
  • T-018-002 Infrastructure and facilities incidents log

T-018-002 Infrastructure and facilities incidents log

Incidents log​

  • Incident code with the format I-XXXX, where XXXX is an incremental numeric identifier starting form 0001.
  • Dates are registered as YYYY-MM-DD.
  • When an incident was considered a non-conformity, registration and follow up must be performed according to GP-006 Non-Conformities. Corrective and preventive actions.
Incident codeReported byReported dateDescriptionActions requiredSolved date

Record signature meaning​

  • Author: JD-007 Author name
  • Review: JD-005 Reviewer name
  • Approval: JD-001 Approver name

Template signature meaning​

info

Delete this section when you create a new record from this template.

  • Author: JD-004 María Diez and/or JD-007 Gerardo Fernández
  • Review: JD-005 Alfonso Medela
  • Approval: JD-001 Andy Aguilar
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T-018-001 Infrastructure list and control plan YYYY_nnn
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Specific procedures
  • Incidents log
  • Record signature meaning
  • Template signature meaning
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.)