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    • GP-001 Documents and records control
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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
    • 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 Software validation
    • GP-023 Change control management
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    • GP-200 Remote Data Acquisition in Clinical Investigations
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  • GP-002 Quality planning
  • Deprecated
  • R-002-003 Quality indicators_2022_001

R-002-003 Quality indicators_2022_001

Version control​

Reason for reviewDateVersion id
First version202212091
Written byReviewed byApproved by

E-Signature (Appfire integration):

Signature logo

María Diez

2D2C2CB4ED52D808CC3720EE26D2583D

Signer name: María Diez

Signing time: Sat, 11 Feb 2023 12:37:23 GMT

Reason: Creation of document

E-Signature (Appfire integration):

Signature logo

Alfonso Medela

28B350CA7DD7B2DF992576D411E82178

Signer name: Alfonso Medela

Signing time: Mon, 13 Feb 2023 12:49:45 GMT

Reason: Reviewed

E-Signature (Appfire integration):

Signature logo

Andy Aguilar

B356A87AF93A14C8A4AD6BAF30EEFB79

Signer name: Andy Aguilar

Signing time: Tue, 14 Feb 2023 12:48:53 GMT

Reason: Approving document

Quality manager (QM)Technical manager (PRRC)General manager (GM)

Indicators scorecards​

Process#IndicatorFrequencyJanFebMarAprMayJunJulAugSepOctNovDecTargetDirectionYearly growthResultsAchievedOwner
Leadership1Quality objectives accomplishment12✅50%DirectStatic50%✅Manager
Leadership2Employee worktime (avoid overtime)12✅110%InverseStatic100%✅Manager
Leadership3N/AN/AN/AN/AN/AN/AN/AN/A
Design and development4Number of design non-conformities6✅✅5InverseStatic5✅R&D Manager
Design and development5Design inputs/outputs achievement12✅95%DirectStatic100%✅R&D Manager
Design and development6N/AN/AN/AN/AN/AN/AN/AN/A
Sales7Availability of public software information3✅✅✅✅100%DirectStatic100%✅Sales
Sales8Number of social networks publications3✅✅✅✅2DirectStatic60✅Sales
Sales9Number of sold products greater12✅10DirectStatic14✅Sales
Purchases10Number of non-conformities from suppliers12✅5InverseStatic0✅Administration
Purchases11Number of purchases non-conformities12✅10InverseStatic0✅Administration
Purchases12N/AN/AN/AN/AN/AN/AN/AN/A
Production13Number of production non-conformities12✅4InverseStatic1✅R&D Manager
Production14N/AN/AN/AN/AN/AN/AN/AN/A
Production15N/AN/AN/AN/AN/AN/AN/AN/A
Quality control16Satisfactory quality control results12✅100%DirectStatic100%✅Quality Manager
Quality control17Customer access to software lastest version12✅100%DirectStatic100%✅Quality Manager
Quality control18N/AN/AN/AN/AN/AN/AN/AN/A
Technical assistance19Number of technical assistance incidents12✅10InverseStatic16❌R&D Manager
Technical assistance20Number of times that the access to the software has been disabled12✅5InverseStatic0✅R&D Manager
Technical assistance21N/AN/AN/AN/AN/AN/AN/AN/A
Post-market surveillance22Number of communicated incidents to NCA12✅0InverseStatic0✅PRRC
Post-market surveillance23Number of non-conformities related to the vigilance system or PMS12✅3InverseStatic0✅PRRC
Post-market surveillance24N/AN/AN/AN/AN/AN/AN/AN/A
Operations25Satisfactory software validation results6✅✅95%DirectStatic100%✅R&D Manager
Operations26Number of infrastructure non conformities6✅✅3InverseStatic1✅R&D Manager
Operations27N/AN/AN/AN/AN/AN/AN/AN/A
Human resources28Number of training hours per person (at least)12✅12DirectStatic12✅Administration
Human resources29Satisfactory training report results12✅80%DirectStatic100%✅Administration
Human resources30Number of non-conformities related to training12✅3InverseStatic3✅Administration
Quality management31Number of quality non-conformities12✅8InverseStatic25❌PRRC
Quality management32Number of accomplished quality objectives per Number of total quality objectives12✅50%DirectStatic50%✅PRRC
Quality management33Number of customer complaints12✅3InverseStatic1✅PRRC
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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.)