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      • R-002-001 Quality objectives list_2024_001
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      • 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-002-003 Quality indicators_2024
      • R-002-004 Annual management review report
      • R-002-005 Quality Calendar_2025
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  • R-002-002 Quality objectives_2025_004

R-002-002 Quality objectives_2025_004

Objective details​

Objective number​

4

Description​

Strengthen technical documentation management among the different markets

Establishment date​

January 2025

This is a new quality objective identified for 2025 which aims to implement a robust system to manage the technical documentation (especially IFU) created for each new market.

This quality objective is triggered by the expansion in new markets to ensure regulatory compliance in each target market.

Planning​

Responsible​

JD-005, JD-003, JD-004

Departments involved​

The main departments involved in the implementation of this quality objective are the product development and quality & regulatory departments.

Planned actions for 2025 period​

  1. Define how to manage technical documentation per each country (especially IFU) based on applicable regulatory requirements
  2. Implement the defined strategy
  3. Maintain technical documentation up to date according to changes in products or any other information provided in the technical documentation

Resources needed​

Monitoring and follow up​

Period% CompletionFollow upShort-term actions
Q1 2025
Q2 2025
Q3 2025
Q4 2025

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-004
  • Reviewer: JD-001
  • Approver: JD-001
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  • Objective details
    • Objective number
    • Description
    • Establishment date
  • Planning
    • Responsible
    • Departments involved
    • Planned actions for 2025 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.)