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      • R-002-001 Quality objectives list_2024_001
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      • 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
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  • GP-002 Quality planning
  • R-002-003 Quality indicators_2024

R-002-003 Quality indicators_2024

Review details​

  • Period analyzed: entire 2024

Indicators scorecards​

ProcessIDIndicatorIndicator's descriptionFrequencyJanFebMarAprMayJunJulAugSepOctNovDecYearly TargetDirectionYearly growthResultAchievedOwner
Leadership1Quality objectives accomplishment% of quality objectives accomplished in the period under evaluation3TRUETRUETRUETRUE50%DirectStatic52.6%TRUEJD-004
Leadership2Employee worktime (avoid overtime)% of employee actual worktime compared to worktime defined in the contract (to monitor overtime) in the period under evaluation6TRUETRUE100%DirectStatic100.00%TRUEJD-006
Leadership3Employee turnaround% of employee turnaround in the period under evaluation12TRUE10%InverseStatic26.32%FALSEJD-006
Design and development4Number of design non-conformitiesNumber of non-conformities triggered by design issues opened in the period under evaluation6TRUETRUE5InverseStatic4TRUEJD-005
Design and development5Design inputs/outputs achievement% of actual design implementation compared to the plan of new design implementation6TRUETRUE95%DirectStatic100%TRUEJD-005
Design and development6Number of requirements that fullfill expectations% of new and/or revised requirements successfully tested during the period under evaluation12TRUE95%DirectStatic100%TRUEJD-005
Sales7Number of new contracts signed with clientsNumber of new contracts signed with clients in the period under evaluation3TRUETRUETRUETRUE5DirectStatic13TRUEJD-002
Sales8Requests to the production APINumber of requests to the production API in the period under evaluation3TRUETRUETRUETRUE6,000DirectStatic55,686TRUEJD-002
Sales9Increase in sales turnoverIncrease of sales turnover (%) compared to the same period (quarter) of the previous year3TRUETRUETRUETRUE250%DirectStatic13%FALSEJD-002
Purchases10Number of non-conformities from suppliersNumber of non-conformities triggered by approved suppliers opened in the period under evaluation6TRUETRUE5InverseStatic0TRUEJD-004
Purchases11Number of purchases non-conformitiesNumber of purchase orders non-conformities opened in the period under evaluation6TRUETRUE10InverseStatic0TRUEJD-004
Purchases12Number of discarded suppliersNumber of approved suppliers that have been discarded in the period under evaluation12TRUE1InverseStatic0TRUEJD-004
Quality control16Satisfactory quality control results% of quality controls performed successfully on the entire QMS12TRUE90%DirectStatic100%TRUEJD-004
Quality control17Customers who access the device's latest version% of customers who access the device's latest version during the period under evaluation12TRUE66%DirectStatic100%TRUEJD-004
Quality control18Satisfactory software validation results% of software validation performed successfully during the period under evaluation (software validation required in the period under evaluation)12TRUE95%DirectStatic100%TRUEJD-004
Technical assistance19Number of technical assistance incidentsNumber of technical assistance incidents opened during the period under evaluation6TRUETRUE10InverseStatic2TRUEJD-005
Technical assistance20Number of times that the access to the software has been disabledNumber of times that the access to the software has been disabled due to technical issues during the period under evaluation6TRUETRUE5InverseStatic1TRUEJD-005
Technical assistance21Times we did not meet the Service Level Agreement (SLA) stipulationsNumber of times we did not meet the Service Level Agreement (SLA) stipulations during the period under evaluation6TRUETRUE3InverseStatic1TRUEJD-005
Post-market surveillance22Number of communicated incidents to National Competent Authority (NCA)Number of communicated incidents to National Competent Authority (NCA) in the period under evaluation6TRUETRUE0InverseStatic0TRUEJD-004
Post-market surveillance23Number of non-conformities related to the vigilance system or PMSNumber of non-conformities related to the vigilance system or PMS opened during the period under evaluation6TRUETRUE3InverseStatic0TRUEJD-004
Post-market surveillance24Number of recallsNumber of recalls initiated in the period under evaluation12TRUE0InverseStatic0TRUEJD-004
Operations25Number of data breachesNumber of data breaches in the period under evaluation6TRUETRUE0InverseStatic0TRUEJD-003
Operations26Number of infrastructure non-conformitiesNumber of infrastructure non-conformities opened in the period under evaluation6TRUETRUE3InverseStatic0TRUEJD-003
Operations27Expenses increaseExpenses increase in the period under evaluation3TRUETRUETRUETRUE10%InverseStatic8%TRUEJD-003
Human resources28Number of training hours per personNumber of training hours for each team member in the period under evaluation12TRUE3DirectStatic23TRUEJD-006
Human resources29Satisfactory training report results% of training reports with satisfactory results in the period under evaluation12TRUE80%DirectStatic94.4%TRUEJD-006
Human resources30Number of non-conformities related to HRNumber of non-conformities related to HR process opened in the period under evaluation6TRUETRUE3InverseStatic1TRUEJD-004
Quality management31Number of QMS non-conformitiesNumber of QMS process non-conformities (deviation from QMS procedure or procedure not fully compliant with applicable requirements) opened in the period under evaluation6TRUETRUE8InverseStatic9FALSEJD-004
Quality management32Number of quality activities performed by the deadline% of quality activities (established in the quality calendar) performed by the due date in the period under evaluation12TRUE75%DirectStatic85%TRUEJD-004
Quality management33Number of customer complaintsNumber of customer complaints opened in the period under evaluation12TRUE5InverseStatic3TRUEJD-004

Indicators summary per area​

Leadership​

Indicator #123
OwnerJD-004JD-006JD-006
NameQuality objectives accomplishmentEmployee worktime (avoid overtime)Employee turnaround
Target50%110%10%
DirectionDirectDirectInverse
Result52.6%100%26.32%
GrowthStaticStaticStatic
Frequency3612

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
Result4100%100%
GrowthStaticStaticStatic
Frequency6612

Sales​

Indicator #789
OwnerJD-002JD-002JD-002
NameNumber of new contracts signed with clientsRequests to the production APIIncrease in sales turnover
Target56,000250%
DirectionDirectDirectDirect
Result135568647%
GrowthStaticStaticStatic
Frequency333

Purchases​

Indicator #101112
OwnerJD-001JD-001JD-004
NameNumber of non-conformities from suppliersNumber of purchases non-conformitiesNumber of discarded suppliers
Target5101
DirectionInverseInverseInverse
Result000
GrowthStaticStaticStatic
Frequency6612

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
Result100%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
Result211
GrowthStaticStaticStatic
Frequency666

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
Frequency6612

Operations​

Indicator #252627
OwnerJD-003JD-003JD-001
NameNumber of data breachesNumber of infrastructure non conformitiesExpenses increase
Target0310%
DirectionInverseInverseInverse
Result00226.12%
GrowthStaticStaticStatic
Frequency663

Human resources​

Indicator #282930
OwnerJD-006JD-006JD-006
NameNumber of training hours per person (at least)Satisfactory training report resultsNumber of non-conformities related to HR
Target380%3
DirectionDirectDirectInverse
Result2394.4%1
GrowthStaticStaticStatic
Frequency12126

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
Result985%3
GrowthStaticStaticStatic
Frequency61212

Yearly forecast​

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

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

Indicator 1 Quality objectives accomplishment​

2021202220232024
Target50%50%50%50%
Result50%50%82%52.6%

Indicator 2 Employee worktime (avoid overtime)​

2021202220232024
Target110%110%110%110%
Result100%100%101,2%100%

Indicator 3 Employee turnaround​

2021202220232024
Target10%10%10%10%
ResultN/AN/A68%26.32%

Indicator 4 Number of design non-conformities​

2021202220232024
Target5555
Result3574

Indicator 5 Design inputs/outputs achievement​

2021202220232024
Target95%95%95%95%
Result100%100%100%100%

Indicator 6 Number of requirements that fullfill expectations​

2021202220232024
Target95%95%95%95%
ResultN/AN/A100%100%

Indicator 7 Number of new contracts signed with clients​

2021202220232024
Target5555
ResultN/AN/A1213

Indicator 8 Requests to the production API​

2021202220232024
Target6,0006,0006,0006,000
ResultN/AN/A53,25955,686

Indicator 9 Increase in sales turnover​

2021202220232024
Target220%220%340%250%
ResultN/AN/A52%47%

Indicator 10 Number of non-conformities from suppliers​

2021202220232024
Target5555
Result0000

Indicator 11 Number of purchases non-conformities​

2021202220232024
Target10101010
Result0000

Indicator 12 Number of discarded suppliers​

2021202220232024
Target1111
ResultN/AN/A00

Indicator 16 Satisfactory quality control results​

2021202220232024
Target90%90%90%90%
Result100%100%90%100%

Indicator 17 Customers who access to software lastest version​

2021202220232024
Target66%66%66%66%
Result100%100%100%100%

Indicator 18 Satisfactory software validation results​

2021202220232024
Target95%95%95%95%
ResultN/AN/A100%100%

Indicator 19 Number of technical assistance incidents​

2021202220232024
Target10101010
Result71652

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

2021202220232024
Target5555
Result0021

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

2021202220232024
Target3333
ResultN/AN/A01

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

2021202220232024
Target0000
Result0000

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

2021202220232024
Target3333
Result1000

Indicator 24 Number of recalls performed​

2021202220232024
Target0000
ResultN/AN/A00

Indicator 25 Number of data breaches​

2021202220232024
Target0000
ResultN/AN/A00

Indicator 26 Number of infrastructure non conformities​

2021202220232024
Target3333
Result0100

Indicator 27 Expenses increase​

2021202220232024
Target10%10%10%10%
ResultN/AN/A189.47%226.12%

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

2021202220232024
Target3333
Result301212.123

Indicator 29 Satisfactory training report results​

2021202220232024
Target80%80%80%80%
Result100%100%87%94.4%

Indicator 30 Number of non-conformities related to HR​

2021202220232024
Target3333
Result0311

Indicator 31 Number of quality non-conformities​

2021202220232024
Target8888
Result22579

Indicator 32 Number of quality activities performed before the deadline​

2021202220232024
Target75%75%75%75%
ResultN/AN/A85%85%

Indicator 33 Number of customer complaints​

2021202220232024
Target5555
Result1143

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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R-002-002 Quality objectives_2025_005
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R-002-004 Annual management review report
  • 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.)