Skip to main content
QMSQMS
QMS
  • Welcome to your QMS
  • Quality Manual
  • Procedures
  • Records
    • GP-001 Documents and records control
    • GP-002 Quality planning
      • Deprecated
      • R-002-007
      • R-002-001 Quality objectives list_2024_001
      • R-002-001 Quality objectives list_2025
      • R-002-001 Quality objectives list_2026
      • R-002-002 Quality objectives_2024_001
      • R-002-002 Quality objectives_2024_002
      • R-002-002 Quality objectives_2024_003
      • R-002-002 Quality objectives_2024_004
      • R-002-002 Quality objectives_2024_005
      • R-002-002 Quality objectives_2025_001
      • R-002-002 Quality objectives_2025_002
      • R-002-002 Quality objectives_2025_003
      • R-002-002 Quality objectives_2025_004
      • R-002-002 Quality objectives_2025_005
      • R-002-002 Quality objectives_2026_001
      • R-002-002 Quality objectives_2026_002
      • R-002-002 Quality objectives_2026_003
      • R-002-002 Quality objectives_2026_004
      • R-002-002 Quality objectives_2026_005
      • R-002-003 Quality indicators_2024
      • R-002-003 Quality indicators_2025
      • R-002-003 Quality indicators_2026
      • R-002-004 Annual management review report 2025
      • R-002-004 Annual management review report 2026
      • R-002-005 Quality Calendar_2025
      • R-002-005 Quality Calendar_2026
    • GP-003 Audits
    • 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 Non-product 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
    • GP-011 Provision of service
    • GP-110 Esquema Nacional de Seguridad
  • 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
  • Records
  • GP-002 Quality planning
  • R-002-002 Quality objectives_2026_004

R-002-002 Quality objectives_2026_004

DRAFT

This document is pending review.

Objective details​

Objective number​

4

Description​

Strengthen technical documentation management among the different markets

Establishment date​

January 2026

This objective is an extension of the quality objective 4 established for 2025. With multiple market approvals now in place, it is critical to maintain a robust system for managing market-specific technical documentation.

Planning​

Responsible​

JD-005, JD-003, JD-004

Departments involved​

The main departments involved are Product Development and Quality & Regulatory.

Planned actions for 2026 period​

  1. Maintain the technical documentation management system established in 2025
  2. Implement any improvements identified during 2025
  3. Ensure all IFUs are updated across markets when product changes occur
  4. Automate documentation update workflows where possible
  5. Conduct periodic reviews of documentation consistency across markets
  6. Train new team members on the documentation management system

Resources needed​

Personnel from the product development and quality & regulatory departments.

Monitoring and follow up​

Period% CompletionFollow upShort-term actions
Q1 2026
Q2 2026
Q3 2026
Q4 2026

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: Team members involved
  • Reviewer: JD-003 Design & Development Manager, JD-004 Quality Manager & PRRC
  • Approver: JD-001 General Manager
Previous
R-002-002 Quality objectives_2026_003
Next
R-002-002 Quality objectives_2026_005
  • Objective details
    • Objective number
    • Description
    • Establishment date
  • Planning
    • Responsible
    • Departments involved
    • Planned actions for 2026 period
    • Resources needed
  • Monitoring and follow up
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.)