R-002-003 Quality indicators
This record documents the quality indicators used to monitor the performance of the QMS processes according to ISO 13485:2016 clause 8.2.3.
Revision history
| Version | Date | Description | Author |
|---|---|---|---|
| 1.0 | 2021-02-01 | Initial release. Quality indicators established for QMS process monitoring. | JD-004 |
| 2.0 | 2022-02-01 | Annual review. No changes to indicator definitions or targets. | JD-004 |
| 3.0 | 2023-02-01 | Annual review. Major restructuring: indicators reviewed and modified to improve process control. Indicators #13, #14, #15 deprecated. Some indicators added. | JD-004 |
| 4.0 | 2024-02-13 | Annual review. Updated targets for indicators #2 (worktime) and #9 (sales turnover). | JD-004 |
| 5.0 | 2025-02-13 | Annual review. Updated target for indicator #2 (from 110% to 100%). Indicator #19 renamed to Complaints. | JD-004 |
| 6.0 | 2026-02-23 | Annual review. Migrated to unified JSON format. Added status tracking per year. Deprecated indicators #6, #8, #9, #16, #17, #18, #20, #21, #27. Added indicator #34 (Regulatory submissions). Updated indicator #32 description. Added measurementMethod and formula fields. | JD-004 |
| 6.1 | 2026-02-25 | Added 4 mandatory ENS (Esquema Nacional de Seguridad) indicators: #35 Security incidents, #36 Incident resolution time, #37 Annual security hours, #38 Annual security budget. Added 'Information security' process. | JD-004 |
Quality indicators
35
Total indicators
14
Active in 2025
17
Inactive in 2025
11
Achieved ✅ (of active)
3
Not achieved ❌ (of active)
| # | Process | Indicator | Status | Target | Result | Achieved | Related Objectives |
|---|---|---|---|---|---|---|---|
| 1 | Leadership | Quality objectives accomplishment % of quality objectives accomplished in the period under evaluation | 🟢 Active | ≥50% | 40% | ❌ | all |
| 2 | Leadership | Employee worktime (avoid overtime) % of employee actual worktime compared to worktime defined in the contract (to monitor overtime) | ⚪ Inactive | ≥100% | 100% | ✅ | — |
| 3 | Leadership | Employee turnaround % of employee turnaround in the period under evaluation | ⚪ Inactive | ≤10% | 32% | ❌ | — |
| 4 | Design and development | Number of design non-conformities Number of non-conformities triggered by design issues opened in the period under evaluation | 🟢 Active | ≤5 | 1 | ✅ | 1-mdr-certification4-tech-doc-management |
| 5 | Design and development | Design inputs/outputs achievement % of actual design implementation compared to the plan of new design implementation | 🟢 Active | ≥95% | 100% | ✅ | 1-mdr-certification4-tech-doc-management |
| 6 | Design and development | Number of requirements that fulfill expectations % of new and/or revised requirements successfully tested during the period under evaluation | 🟢 Active | ≥95% | 100% | ✅ | 1-mdr-certification |
| 7 | Sales | Number of new contracts signed with clients Number of new contracts signed with clients in the period under evaluation | ⚪ Inactive | ≥5 | 15 | ✅ | — |
| 8 | Sales | Requests to the production API Number of requests to the production API in the period under evaluation | ⚪ Inactive | ≥6000 | — | — | — |
| 9 | Sales | Increase in sales turnover Increase of sales turnover (%) compared to the same period (quarter) of the previous year | ⚪ Inactive | ≥200% | — | — | — |
| 10 | Purchases | Number of non-conformities from suppliers Number of non-conformities triggered by approved suppliers opened in the period under evaluation | ⚪ Inactive | ≤5 | 0 | ✅ | — |
| 11 | Purchases | Number of purchases non-conformities Number of purchase orders non-conformities opened in the period under evaluation | ⚪ Inactive | ≤10 | 0 | ✅ | — |
| 12 | Purchases | Number of discarded suppliers Number of approved suppliers that have been discarded in the period under evaluation | ⚪ Inactive | ≤1 | 0 | ✅ | — |
| 16 | Quality control | Satisfactory quality control results % of quality controls performed successfully on the entire QMS | ⚪ Inactive | ≥90% | — | — | — |
| 17 | Quality control | Customers who access the device's latest version % of customers who access the device's latest version during the period under evaluation | ⚪ Inactive | ≥66% | — | — | — |
| 18 | Quality control | Satisfactory software validation results % of software validation performed successfully during the period under evaluation | ⚪ Inactive | ≥95% | — | — | — |
| 19 | Technical assistance | Complaints (formerly: Number of technical assistance incidents) Number of complaints received during the period under evaluation | 🟢 Active | ≤10 | 0 | ✅ | 5-customer-satisfaction |
| 20 | Technical assistance | Number of times that the access to the software has been disabled Number of times that the access to the software has been disabled due to technical issues during the period under evaluation | ⚪ Inactive | ≤5 | — | — | — |
| 21 | Technical assistance | Times we did not meet the Service Level Agreement (SLA) stipulations Number of times we did not meet the Service Level Agreement (SLA) stipulations during the period under evaluation | ⚪ Inactive | ≤3 | — | — | — |
| 22 | Post-market surveillance | Number of communicated incidents to National Competent Authority (NCA) Number of serious incidents communicated to National Competent Authorities in the period under evaluation | 🟢 Active | ≤0 | 0 | ✅ | 2-regulatory-clearance |
| 23 | Post-market surveillance | Number of non-conformities related to the vigilance system or PMS Number of non-conformities related to the vigilance system or PMS opened during the period under evaluation | 🟢 Active | ≤3 | 0 | ✅ | 2-regulatory-clearance |
| 24 | Post-market surveillance | Number of recalls Number of recalls initiated in the period under evaluation | 🟢 Active | ≤0 | 0 | ✅ | 1-mdr-certification2-regulatory-clearance |
| 25 | Operations | Number of data breaches Number of data breaches in the period under evaluation | 🟢 Active | ≤0 | 0 | ✅ | 3-cybersecurity |
| 26 | Operations | Number of infrastructure non-conformities Number of infrastructure non-conformities opened in the period under evaluation | 🟢 Active | ≤3 | 0 | ✅ | 3-cybersecurity |
| 27 | Operations | Expenses increase Expenses increase in the period under evaluation | ⚪ Inactive | ≤10% | — | — | — |
| 28 | Human resources | Training hours per person Percentage of employees who completed at least 3 training hours in the period | ⚪ Inactive | ≥100% | 60% | ❌ | — |
| 29 | Human resources | Satisfactory training report results % of training reports with satisfactory results in the period under evaluation | ⚪ Inactive | ≥80% | 82% | ✅ | — |
| 30 | Human resources | Number of non-conformities related to HR Number of non-conformities related to HR process opened in the period under evaluation | ⚪ Inactive | ≤3 | 0 | ✅ | — |
| 31 | Quality management | Number of QMS non-conformities Number of QMS process non-conformities (deviation from QMS procedure or procedure not fully compliant with applicable requirements) opened in the period under evaluation | 🟢 Active | ≤8 | 2 | ✅ | 1-mdr-certification4-tech-doc-management |
| 32 | Quality management | Quality activities performed on time % of quality activities (internal audits, management review, certification audits) performed by the due date in the period under evaluation | 🟢 Active | ≥75% | 67% | ❌ | all |
| 33 | Quality management | Number of customer complaints Number of customer complaints opened in the period under evaluation | 🟢 Active | ≤5 | 0 | ✅ | 5-customer-satisfaction |
| 34 | Regulatory | Regulatory submissions completed Number of regulatory submissions completed in new markets during the period under evaluation | 🟢 Active | ≥5 | 1 | ❌ | 2-regulatory-clearance |
| 35 | Information security | Security incidents (ENS) Number of security incidents affecting the information system within the ENS scope during the period under evaluation | — | — | — | — | |
| 36 | Information security | Incident resolution time (ENS) Time to resolve 50% of security incidents (median resolution time) during the period under evaluation | — | — | — | — | |
| 37 | Information security | Annual security hours (ENS) Planned annual hours dedicated to information security activities (training, audits, incident response, security reviews, configuration hardening, consultancy). Measures efficiency: exceeding the planned cap indicates unplanned effort or inefficiency | — | — | — | — | |
| 38 | Information security | Annual security budget (ENS) Planned annual budget dedicated to information security: security tools (EDR, SIEM), consultancy, training, audits, certifications. Measures efficiency: exceeding the planned cap indicates unplanned expenditure | — | — | — | — |
Status definitions:
- 🟢 Active: Indicator is actively measured and linked to quality objectives
- ⚪ Inactive: Indicator exists but is not linked to any quality objective (process monitoring only)
- 🔴 Deprecated: Indicator is no longer used and will not be measured in future years
35
Total indicators
4
Active in 2026
0
Inactive in 2026
0
Achieved ✅ (of active)
0
Not achieved ❌ (of active)
| # | Process | Indicator | Status | Target | Result | Achieved | Related Objectives |
|---|---|---|---|---|---|---|---|
| 1 | Leadership | Quality objectives accomplishment % of quality objectives accomplished in the period under evaluation | — | — | — | — | |
| 2 | Leadership | Employee worktime (avoid overtime) % of employee actual worktime compared to worktime defined in the contract (to monitor overtime) | — | — | — | — | |
| 3 | Leadership | Employee turnaround % of employee turnaround in the period under evaluation | — | — | — | — | |
| 4 | Design and development | Number of design non-conformities Number of non-conformities triggered by design issues opened in the period under evaluation | — | — | — | — | |
| 5 | Design and development | Design inputs/outputs achievement % of actual design implementation compared to the plan of new design implementation | — | — | — | — | |
| 6 | Design and development | Number of requirements that fulfill expectations % of new and/or revised requirements successfully tested during the period under evaluation | — | — | — | — | |
| 7 | Sales | Number of new contracts signed with clients Number of new contracts signed with clients in the period under evaluation | — | — | — | — | |
| 8 | Sales | Requests to the production API Number of requests to the production API in the period under evaluation | — | — | — | — | |
| 9 | Sales | Increase in sales turnover Increase of sales turnover (%) compared to the same period (quarter) of the previous year | — | — | — | — | |
| 10 | Purchases | Number of non-conformities from suppliers Number of non-conformities triggered by approved suppliers opened in the period under evaluation | — | — | — | — | |
| 11 | Purchases | Number of purchases non-conformities Number of purchase orders non-conformities opened in the period under evaluation | — | — | — | — | |
| 12 | Purchases | Number of discarded suppliers Number of approved suppliers that have been discarded in the period under evaluation | — | — | — | — | |
| 16 | Quality control | Satisfactory quality control results % of quality controls performed successfully on the entire QMS | — | — | — | — | |
| 17 | Quality control | Customers who access the device's latest version % of customers who access the device's latest version during the period under evaluation | — | — | — | — | |
| 18 | Quality control | Satisfactory software validation results % of software validation performed successfully during the period under evaluation | — | — | — | — | |
| 19 | Technical assistance | Complaints (formerly: Number of technical assistance incidents) Number of complaints received during the period under evaluation | — | — | — | — | |
| 20 | Technical assistance | Number of times that the access to the software has been disabled Number of times that the access to the software has been disabled due to technical issues during the period under evaluation | — | — | — | — | |
| 21 | Technical assistance | Times we did not meet the Service Level Agreement (SLA) stipulations Number of times we did not meet the Service Level Agreement (SLA) stipulations during the period under evaluation | — | — | — | — | |
| 22 | Post-market surveillance | Number of communicated incidents to National Competent Authority (NCA) Number of serious incidents communicated to National Competent Authorities in the period under evaluation | — | — | — | — | |
| 23 | Post-market surveillance | Number of non-conformities related to the vigilance system or PMS Number of non-conformities related to the vigilance system or PMS opened during the period under evaluation | — | — | — | — | |
| 24 | Post-market surveillance | Number of recalls Number of recalls initiated in the period under evaluation | — | — | — | — | |
| 25 | Operations | Number of data breaches Number of data breaches in the period under evaluation | — | — | — | — | |
| 26 | Operations | Number of infrastructure non-conformities Number of infrastructure non-conformities opened in the period under evaluation | — | — | — | — | |
| 27 | Operations | Expenses increase Expenses increase in the period under evaluation | — | — | — | — | |
| 28 | Human resources | Training hours per person Percentage of employees who completed at least 3 training hours in the period | — | — | — | — | |
| 29 | Human resources | Satisfactory training report results % of training reports with satisfactory results in the period under evaluation | — | — | — | — | |
| 30 | Human resources | Number of non-conformities related to HR Number of non-conformities related to HR process opened in the period under evaluation | — | — | — | — | |
| 31 | Quality management | Number of QMS non-conformities Number of QMS process non-conformities (deviation from QMS procedure or procedure not fully compliant with applicable requirements) opened in the period under evaluation | — | — | — | — | |
| 32 | Quality management | Quality activities performed on time % of quality activities (internal audits, management review, certification audits) performed by the due date in the period under evaluation | — | — | — | — | |
| 33 | Quality management | Number of customer complaints Number of customer complaints opened in the period under evaluation | — | — | — | — | |
| 34 | Regulatory | Regulatory submissions completed Number of regulatory submissions completed in new markets during the period under evaluation | — | — | — | — | |
| 35 | Information security | Security incidents (ENS) Number of security incidents affecting the information system within the ENS scope during the period under evaluation | 🟢 Active | ≤2 | — | — | |
| 36 | Information security | Incident resolution time (ENS) Time to resolve 50% of security incidents (median resolution time) during the period under evaluation | 🟢 Active | ≤48 | — | — | |
| 37 | Information security | Annual security hours (ENS) Planned annual hours dedicated to information security activities (training, audits, incident response, security reviews, configuration hardening, consultancy). Measures efficiency: exceeding the planned cap indicates unplanned effort or inefficiency | 🟢 Active | ≤170 | — | — | |
| 38 | Information security | Annual security budget (ENS) Planned annual budget dedicated to information security: security tools (EDR, SIEM), consultancy, training, audits, certifications. Measures efficiency: exceeding the planned cap indicates unplanned expenditure | 🟢 Active | ≤7000 | — | — |
Status definitions:
- 🟢 Active: Indicator is actively measured and linked to quality objectives
- ⚪ Inactive: Indicator exists but is not linked to any quality objective (process monitoring only)
- 🔴 Deprecated: Indicator is no longer used and will not be measured in future years
References
- ISO 13485:2016 clause 8.2.3 - Monitoring and measurement of processes
- ISO 13485:2016 clause 5.6 - Management review
- Real Decreto 311/2022 - Esquema Nacional de Seguridad (ENS), OP.MON.2
- R-002-001 Quality objectives list
- R-002-002 Quality objectives monitoring
Data source
The indicator data is stored in r-002-003.json for data integrity and traceability.
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