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      • Deprecated
        • R-002-001 Quality objectives list_2023_001
        • R-002-002 Quality objectives_2023_001
        • R-002-002 Quality objectives_2023_002
        • R-002-002 Quality objectives_2023_003
        • R-002-002 Quality objectives_2023_004
        • R-002-002 Quality objectives_2023_005
        • R-002-002 Quality objectives_2023_006
        • R-002-003 Quality indicators_2022_001
        • R-002-003 Quality indicators_2023_001
        • R-002-004 Annual management review report_2023_001
        • R-002-005 Quality Calendar_2023_001
        • R-002-005 Quality Calendar_22_001
        • R-002-006 SWOT and CAME analysis_2023_001
        • R-002-007 Process validation card 2023_013
        • R-002-008 Quality and regulatory roadmap_2023_001
      • R-002-001 Quality objectives list_2024_001
      • R-002-001 Quality objectives list_2025
      • 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
      • R-002-007
      • R-002-008 Quality and regulatory roadmap
      • R-002-009 Regulatory requirements review report
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  • R-002-002 Quality objectives_2023_002

R-002-002 Quality objectives_2023_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​

January 2022

The objective was established last year as it is a long term objective. Notified bodies have a high waiting list due to the new European regulations for the MD and IVD.

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 2023 period​

  1. To sign a contract with a Notified Body (NB).
  2. Complete the transition of the QMS to the new QMS Legit.Health (Objective 3).
  3. Perform a satisfactory internal audit of the new QMS Legit.Health.

Resources needed​

  • Financial resources for the Notified Body payment (aproximately 85k €, together with objective 1): BSI is the Notified Body selected.
  • Personnel for quality activities performance.
  • Financial resources for the internal audit performance

Monitoring and follow up​

Period% CompletionFollow upShort-term actions
Q1 202375%Pending contract with the NB, complete the transition to the new QMS and perform the internal auditContinue with the QMS transition.
Q2 202385%We have completed the transition to the new QMS. We signed a contract with BSI as our Notified Body. We also have hired one of our consultants to perform the QMS internal audit.To confirm the dates of the internal audit with the consultant and the first audits with BSI.
Q3 202395%During last September we performed the internal audit with satisfactory results regarding the ISO13485 implementation. In addition, BSI confirmed the dates for the ISO13485.Complete and solve the NC found during the internal audit
Q4 202397%During the 4Q we submitted the required documentation to BSI to complete the first review of the QMS documentation. In addition, we passed with satisfactory results (only 2 minor non-conformities) the ISO 13485 stage 1 audit remotely held in November. We immediately solved the NC and the auditor accepted the reports sent as closed NC. He also qualified us for the state 2 of the audit.Continue performing the activities programmed in the different procedures of our QMS to ensure we continue complying with it and with the applicable regulatory requirements.

Status​

  • [] In progress
  • [] Completed
  • Extended
  • [] Discarded

Record signature meaning

  • Author: JD-004 María Diez
  • Review and approval: JD-001 Andy Aguilar
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  • Objective details
    • Objective number: 2
    • Description
    • Establishment date
  • Planning
    • Responsible
    • Departments involved
    • Planned actions for 2023 period
    • Resources needed
  • Monitoring and follow up
  • Status
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.)