Skip to main content
QMSQMS
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
    • GP-011 Provision of service
    • GP-110 Esquema Nacional de Seguridad
  • Legit.Health Plus Version 1.1.0.0
  • Legit.Health Plus Version 1.1.0.1
  • Licenses and accreditations
  • Applicable Standards and Regulations
  • Grants
  • Public tenders
  • Records
  • GP-002 Quality planning
  • Deprecated
  • R-002-003 Quality indicators_2023_001

R-002-003 Quality indicators_2023_001

Review details​

  • Record completed by: María Diez, JD-004
  • Record review: 2024_02_13
  • Period analyzed: Q1+Q2+Q3+Q4

Indicators scorecards​

Process#IndicatorFrequencyJanFebMarAprMayJunJulAugSepOctNovDecTargetDirectionYearly growthResultsAchievedOwner
Leadership1Quality objectives accomplishment12TRUETRUETRUETRUE50%DirectStatic75%82TRUEJD-001
Leadership2Employee worktime (avoid overtime)6TRUETRUE110%DirectStatic101,2%TRUEJD-001
Leadership3Employee turnaround12TRUE10%InverseStatic67.60%FALSEJD-001
Design and development4Number of design non-conformities6TRUETRUE5InverseStatic7FALSEJD-005
Design and development5Design inputs/outputs achievement12TRUETRUE95%DirectStatic100%TRUEJD-005
Design and development6Number of requirements that fullfill expectations12TRUE95%DirectStatic100%TRUEJD-005
Sales7Number of new contracts signed with clients3TRUETRUETRUETRUE5DirectStatic12TRUEJD-002
Sales8Requests to the production API3TRUETRUETRUETRUE6,000DirectStatic53259TRUEJD-002
Sales9Increase in sales turnover12TRUETRUETRUETRUE220%DirectStatic54%FALSEJD-002
Purchases10Number of non-conformities from suppliers12TRUETRUE5InverseStatic0TRUEJD-001
Purchases11Number of purchases non-conformities12TRUETRUE10InverseStatic0TRUEJD-001
Purchases12Number of discarded suppliers12TRUE1InverseStatic0TRUEJD-004
Quality control16Satisfactory quality control results12TRUE90%DirectStatic90%TRUEJD-004
Quality control17Customers who access the device's lastest version12TRUE66%DirectStatic100%TRUEJD-004
Quality control18Satisfactory software validation results12TRUE95%DirectStatic100%TRUEJD-004
Technical assistance19Number of technical assistance incidents12TRUETRUE10InverseStatic5TRUEJD-005
Technical assistance20Number of times that the access to the software has been disabled12TRUETRUE5InverseStatic2TRUEJD-005
Technical assistance21Times we did not meet the Service Level Agreement (SLA) stipulations6TRUETRUE3InverseStatic0TRUEJD-005
Post-market surveillance22Number of communicated incidents to National Competent Authority (NCA)12TRUETRUE0InverseStatic0TRUEJD-004
Post-market surveillance23Number of non-conformities related to the vigilance system or PMS12TRUETRUE3InverseStatic0TRUEJD-004
Post-market surveillance24Number of recalls performed12TRUE0InverseStatic0TRUEJD-004
Operations25Number of data breaches6TRUETRUE0InverseN/A0TRUEJD-003
Operations26Number of infrastructure non conformities6TRUETRUE3InverseStatic0TRUEJD-003
Operations27Expenses increase3TRUETRUETRUETRUE10%InverseStatic175.69%FALSEJD-003
Human resources28Number of training hours per person (at least)12TRUE3DirectStatic12.1TRUEJD-001
Human resources29Satisfactory training report results12TRUE80%DirectStatic87%TRUEJD-001
Human resources30Number of non-conformities related to HR12TRUETRUE3InverseStatic1TRUEJD-001
Quality management31Number of quality non-conformities12TRUETRUE8InverseStatic7TRUEJD-004
Quality management32Number of quality activities performed before the deadline12TRUE75%DirectStatic85%TRUEJD-004
Quality management33Number of customer complaints12TRUE5InverseStatic4TRUEJD-004

For every process included in the table above, yearly (at the begining of the following year), a new summary table will be created as follows:

Indicators summary per area​

Leadership​

Indicator #123
OwnerJD-001JD-001JD-001
NameQuality objectives accomplishmentEmployee worktime (avoid overtime)Employee turnaround
Target50%110%10%
DirectionDirectDirectInverse
Result82%101,2%67.60%
GrowthStaticStaticStatic
Frequency12612

Design and development​

Indicator #456
OwnerJD-005JD-005JD-005
NameNumber of design non-conformitiesDesign inputs/outputs achievementNumber of requirements that fullfill expectations
Target595%95%
DirectionInverseDirectDirect
Result7100%100%
GrowthStaticStaticStatic
Frequency61212

Sales​

Indicator #789
OwnerJD-002JD-002JD-002
NameNumber of new contracts signed with clientsRequests to the production APIIncrease in sales turnover
Target56,000220%
DirectionDirectDirectDirect
Result1253,25954%
GrowthStaticStaticStatic
Frequency3312

Purchases​

Indicator #101112
OwnerJD-001JD-001JD-004
NameNumber of non-conformities from suppliersNumber of purchases non-conformitiesNumber of discarded suppliers
Target5101
DirectionInverseInverseInverse
Result000
GrowthStaticStaticStatic
Frequency121212

Quality Control​

Indicator #161718
OwnerJD-004JD-004JD-004
NameSatisfactory quality control resultsCustomers who access the device's lastest versionSatisfactory software validation results
Target90%66%95%
DirectionDirectDirectDirect
Result90%100%100%
GrowthStaticStaticStatic
Frequency121212

Technical assistance​

Indicator #192021
OwnerJD-005JD-005JD-005
NameNumber of technical assistance incidentsNumber of times that the access to the software has been disabledTimes we did not meet the Service Level Agreement (SLA) stipulations
Target1053
DirectionInverseInverseInverse
Result520
GrowthStaticStaticStatic
Frequency12126

Post-market surveillance​

Indicator #222324
OwnerJD-004JD-004JD-004
NameNumber of communicated incidents to National Competent Authority (NCA)Number of non-conformities related to the vigilance system or PMSNumber of recalls performed
Target030
DirectionInverseInverseInverse
Result000
GrowthStaticStaticStatic
Frequency121212

Operations​

Indicator #252627
OwnerJD-003JD-003JD-003
NameNumber of data breachesNumber of infrastructure non conformitiesExpenses increase
Target0310%
DirectionInverseInverseInverse
Result00175.69%
GrowthN/AStaticStatic
Frequency663

Human resources​

Indicator #282930
OwnerJD-001JD-001JD-001
NameNumber of training hours per person (at least)Satisfactory training report resultsNumber of non-conformities related to HR
Target380%3
DirectionDirectDirectInverse
Result12.187%1
GrowthStaticStaticStatic
Frequency121212

Quality management​

Indicator #313233
OwnerJD-004JD-004JD-004
NameNumber of quality non-conformitiesNumber of quality activities performed before the deadlineNumber of customer complaints
Target875%5
DirectionInverseDirectInverse
Result785%4
GrowthStaticStaticStatic
Frequency121212

Yearly forecast​

For every indicator a yearly table will be created as follows:

At the begining of the 2023 period, the indicators were reviewed and some of them were modified to improve the control of the procedures. By this reason, some of the yearly table's indicators have not data from 2021 and 2022.

Indicator 1 Quality objectives accomplishment​

202120222023
Target50%50%50%
Result50%50%82%

Indicator 2 Employee worktime (avoid overtime)​

202120222023
Target110%110%110%
Result100%100%101,2%

Indicator 3 Employee turnaround​

202120222023
Target10%10%10%
ResultN/AN/A68%

Indicator 4 Number of design non-conformities​

202120222023
Target555
Result357

Indicator 5 Design inputs/outputs achievement​

202120222023
Target95%95%95%
Result100%100%100%

Indicator 6 Number of requirements that fullfill expectations​

202120222023
Target95%95%95%
ResultN/AN/A100%

Indicator 7 Number of new contracts signed with clients​

202120222023
Target555
ResultN/AN/A12

Indicator 8 Requests to the production API​

202120222023
Target6,0006,0006,000
ResultN/AN/A53,259

Indicator 9 Increase in sales turnover​

202120222023
Target220%220%220%
ResultN/AN/A54%

Indicator 10 Number of non-conformities from suppliers​

202120222023
Target555
Result000

Indicator 11 Number of purchases non-conformities​

202120222023
Target101010
Result000

Indicator 12 Number of discarded suppliers​

202120222023
Target111
ResultN/AN/A0

Indicator 16 Satisfactory quality control results​

202120222023
Target90%90%90%
Result100%100%90%

Indicator 17 Customers who access to software lastest version​

202120222023
Target66%66%66%
Result100%100%100%

Indicator 18 Satisfactory software validation results​

202120222023
Target95%95%95%
ResultN/AN/A100%

Indicator 19 Number of technical assistance incidents​

202120222023
Target101010
Result7165

Indicator 20 Number of times that the access to the software has been disabled​

202120222023
Target555
Result002

Indicator 21 Times we did not meet the Service Level Agreement (SLA) stipulations​

202120222023
Target333
ResultN/AN/A0

Indicator 22 Number of communicated incidents to National Competent Authority (NCA)​

202120222023
Target000
Result000

Indicator 23 Number of non-conformities related to the vigilance system or PMS​

202120222023
Target333
Result100

Indicator 24 Number of recalls performed​

202120222023
Target000
ResultN/AN/A0

Indicator 25 Number of data breaches​

202120222023
Target000
ResultN/AN/A0

Indicator 26 Number of infrastructure non conformities​

202120222023
Target333
Result010

Indicator 27 Expenses increase​

202120222023
Target10%10%10%
ResultN/AN/A175.69%

Indicator 28 Number of training hours per person (at least)​

202120222023
Target333
Result301212.1

Indicator 29 Satisfactory training report results​

202120222023
Target80%80%80%
Result100%100%87%

Indicator 30 Number of non-conformities related to HR​

202120222023
Target333
Result031

Indicator 31 Number of quality non-conformities​

202120222023
Target888
Result2257

Indicator 32 Number of quality activities performed before the deadline​

202120222023
Target75%75%75%
ResultN/AN/A85%

Indicator 33 Number of customer complaints​

202120222023
Target555
Result114

Record signature meaning

  • Author: JD-004 María Diez
  • Review and approval: JD-001
Previous
R-002-003 Quality indicators_2022_001
Next
R-002-004 Annual management review report_2023_001
  • Review details
  • Indicators scorecards
  • Indicators summary per area
    • Leadership
    • Design and development
    • Sales
    • Purchases
    • Quality Control
    • Technical assistance
    • Post-market surveillance
    • Operations
    • Human resources
    • Quality management
  • Yearly forecast
    • Indicator 1 Quality objectives accomplishment
    • Indicator 2 Employee worktime (avoid overtime)
    • Indicator 3 Employee turnaround
    • Indicator 4 Number of design non-conformities
    • Indicator 5 Design inputs/outputs achievement
    • Indicator 6 Number of requirements that fullfill expectations
    • Indicator 7 Number of new contracts signed with clients
    • Indicator 8 Requests to the production API
    • Indicator 9 Increase in sales turnover
    • Indicator 10 Number of non-conformities from suppliers
    • Indicator 11 Number of purchases non-conformities
    • Indicator 12 Number of discarded suppliers
    • Indicator 16 Satisfactory quality control results
    • Indicator 17 Customers who access to software lastest version
    • Indicator 18 Satisfactory software validation results
    • Indicator 19 Number of technical assistance incidents
    • Indicator 20 Number of times that the access to the software has been disabled
    • Indicator 21 Times we did not meet the Service Level Agreement (SLA) stipulations
    • Indicator 22 Number of communicated incidents to National Competent Authority (NCA)
    • Indicator 23 Number of non-conformities related to the vigilance system or PMS
    • Indicator 24 Number of recalls performed
    • Indicator 25 Number of data breaches
    • Indicator 26 Number of infrastructure non conformities
    • Indicator 27 Expenses increase
    • Indicator 28 Number of training hours per person (at least)
    • Indicator 29 Satisfactory training report results
    • Indicator 30 Number of non-conformities related to HR
    • Indicator 31 Number of quality non-conformities
    • Indicator 32 Number of quality activities performed before the deadline
    • Indicator 33 Number of customer complaints
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.)