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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
      • R-002-006 SWOT and CAME analysis
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      • R-002-008 Quality and regulatory roadmap
      • R-002-009 Regulatory requirements review report
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  • R-002-002 Quality objectives_2024_002

R-002-002 Quality objectives_2024_002

Objective details​

Objective number​

2

Description​

Certification of the AI LABS GROUP's QMS under EN-ISO 13485 by a Notified Body.

Establishment date​

February 2024.

The objective was established 2 years ago and during the annual management review on February 13, 2024, it has been decided to extend it because it is not fully achieved. Stage 1 of the audit was successfully conducted in November 2023 while Stage 2 of the audit is scheduled for February 20 and 21, 2024.

Planning​

Responsible​

JD-004

Departments involved​

As it is a huge objective, all the departments are involved, but the main department developing the objective is Quality & Regulatory.

Planned actions for 2024 period​

  1. Perform Stage 2 of ISO 13485 audit
  2. Address the findings from Stage 2 audit in a timely manner according to the duedates established by BSI auditors

Resources needed​

  • Personnel from product development and quality & regulatory departments.

Monitoring and follow up​

Period% CompletionFollow upShort-term actions
Q1 202490%We had the second stage BSI audit on February 20 and 21, 2024. The audit ended with 5 minor nonconformities. We submitted the corrective action plan to BSI on February 29 and on March 26 the BSI auditor notified us of the rejection of the corrective action plan. We reviewed and submitted the corrective action plan to BSI on April 2 and the same day we received confirmation of acceptance of the plan, therefore we will receive the ISO 13485:2016 certificate and the resolution of the 5 minor nonconformities will be assessed by BSI during the next external auditImplement all the corrective actions and verify their effectiveness according to the established due dates
Q2 202495%We implemented all the corrections and corrective actions established for each minor nonconformity. We also assessed the effectiveness of some of the corrective actions implemented and the result was that the effectiveness is successfully verified. We received the mock up ISO 13485 certificate and we are currently waiting for the official certifcate (it was expected for the month of July).Monitor the effectiveness of the corrective actions implemented (for the CAPA that still require verification of the effectiveness)
Q3 2024100%We received the ISO 13485 certificate on August 27, 2024. All the corrective actions initiated to address the audit nonconformities have been implemented and their effectiveness is under evaluation.No further actions needed, objective fully achieved. We will monitor the effectiveness of the corrective actions as part of the standard QMS maintenance activities.
Q4 2024n/an/an/a

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 2024 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.)