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QMSQMS
QMS
  • Welcome to your QMS
  • Quality Manual
  • Procedures
    • GP-001 Control of documents
    • GP-002 Quality planning
      • Templates
        • T-002-001 Quality objectives list
        • T-002-002 Quality objectives
        • T-002-003 Quality indicators
        • T-002-004 Anual management review report
        • T-002-005 Quality Calendar_YYYY_nnn
        • T-002-006 SWOT and CAME analysis
        • T-002-007 Process validation card
        • T-002-009 Regulatory requirements review report
    • 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 Predetermined Change Control Plan
    • GP-025 Usability and Human Factors Engineering
    • GP-027 Corporate Governance
    • GP-028 AI Development
    • GP-029 Software Delivery and Commissioning
    • GP-030 Cyber Security Management
    • 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
    • GP-026 Market-specific product requirements
    • GP-110 Esquema Nacional de Seguridad
  • Records
  • Legit.Health Plus Version 1.1.0.0
  • Legit.Health Plus Version 1.1.0.1
  • Legit.Health Utilities
  • Licenses and accreditations
  • Applicable Standards and Regulations
  • Pricing
  • Public tenders
  • Procedures
  • GP-002 Quality planning
  • Templates
  • T-002-004 Anual management review report

T-002-004 Anual management review report

Meeting details​

Assistants​

NamePositionSignature

Place​

Date​

Inputs​

Quality policy and objectives review​

Feedback​

Treatment of claims​

Notifications to regulatory authorities​

Audits​

Monitoring and measurement of processes​

Monitoring and measurement of the product​

Non-conformities. Corrective and preventive actions​

Follow-up actions from previous management reviews​

Changes that could affect the QMS​

Recommendations for improvement​

New or revised applicable regulatory requirements​

Outputs​

Necessary improvements to maintain the suitability, adequacy and effectiveness of the QMS and its processes​

Product improvement in relation to customer requirements​

Necessary changes to respond to new or revised applicable regulatory requirements​

Necessary updates to Risk Management record​

Necessary updates to Clinical Evaluation​

Necessary resources​

Signature meaning

The signatures for the approval process of this document can be found in the verified commits at the repository for the QMS. As a reference, the team members who are expected to participate in this document and their roles in the approval process, as defined in Annex I Responsibility Matrix of the GP-001, are:

  • Author: JD-003, JD-004
  • Reviewer: JD-005
  • Approver: JD-001
Previous
T-002-003 Quality indicators
Next
T-002-005 Quality Calendar_YYYY_nnn
  • Meeting details
    • Assistants
    • Place
    • Date
  • Inputs
    • Quality policy and objectives review
    • Feedback
    • Treatment of claims
    • Notifications to regulatory authorities
    • Audits
    • Monitoring and measurement of processes
    • Monitoring and measurement of the product
    • Non-conformities. Corrective and preventive actions
    • Follow-up actions from previous management reviews
    • Changes that could affect the QMS
    • Recommendations for improvement
    • New or revised applicable regulatory requirements
  • Outputs
    • Necessary improvements to maintain the suitability, adequacy and effectiveness of the QMS and its processes
    • Product improvement in relation to customer requirements
    • Necessary changes to respond to new or revised applicable regulatory requirements
    • Necessary updates to Risk Management record
    • Necessary updates to Clinical Evaluation
    • Necessary resources
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.)