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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
      • Templates
        • T-013-001 Risk management plan
        • T-013-002 Risk management record_YYYY_nnn
        • T-013-003 Risk management report
    • 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-013 Risk management
  • Templates
  • T-013-002 Risk management record_YYYY_nnn

T-013-002 Risk management record_YYYY_nnn

This record is carried out folloing the procedure GP-013 Risk management, and according to R-TF-013-001 Risk management plan, which is also carried out following GP-013. The definition of the risk control options, the risk levels, risk acceptability and everything else, can be found in GP-013 Risk management.

Risk analysisInitial risk evaluationRisk controlEvaluation of overall residual risksRisk minimization
ItemHazard and hazardous situationRelated toTypePeople affectedPart affectedRiskForeseeable sequence of eventsHarmPotencial cause(s) or mechanism(s) of failureSeverityLikelyhoodRPNSelected optionImplanted mitigation measuresResponsibleEvidence / Verification of control measuresSeverityLikelyhoodRPNRisk levelRisk acceptability (Y/N)Selected optionAdditional control measuresRisks arising from risk control measures (y/n)Benefit-Risk Analysis (Y-N/R-N)
1

Record signature meaning​

  • Author: JD-004 Author name
  • Review: JD-003 Reviewer name
  • Approval: JD-005 Approver name

Template signature meaning​

info

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

  • Author: JD-004 María Diez
  • Review: JD-005 Alfonso Medela
  • Approval: JD-001 Andy Aguilar
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T-013-001 Risk management plan
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T-013-003 Risk management report
  • 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.)