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QMS
  • Welcome to your QMS
  • Quality Manual
  • Procedures
  • Records
    • GP-001 Documents and records control
    • GP-002 Quality planning
      • 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
    • GP-050 Data Protection
    • GP-051 Security violations
    • GP-052 Data Privacy Impact Assessment (DPIA)
    • GP-200 Remote Data Acquisition in Clinical Investigations
  • Legit.Health Plus Version 1.1.0.0
  • Legit.Health Plus Version 1.1.0.1
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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

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

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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