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QMSQMS
QMS
  • Welcome to your QMS
  • Quality Manual
  • Procedures
    • GP-001 Control of documents
    • GP-002 Quality planning
      • Specific procedures
      • Templates
        • Deprecated
        • T-002-001 Quality objectives list
        • T-002-002 Quality objectives
        • T-002-003 Quality indicators
        • T-002-004 Anual management review report
        • T-002-005 Quality Calendar_YYYY_nnn
        • T-002-007 Process validation card
    • GP-003 Audits
    • GP-004 Vigilance system
    • GP-005 Human Resources and Training
    • GP-006 Non-conformity, Corrective and Preventive actions
    • GP-007 Post-market surveillance
    • GP-009 Sales
    • GP-010 Purchases and suppliers evaluation
    • GP-011 Provision of service
    • GP-012 Design, redesign and development
    • GP-013 Risk management
    • GP-014 Feedback and complaints
    • GP-015 Clinical evaluation
    • GP-016 Traceability and identification
    • GP-017 Technical assistance service
    • GP-018 Infrastructure and facilities
    • GP-019 Non-product software validation
    • GP-020 QMS Data analysis
    • GP-021 Communications
    • GP-022 Document translation
    • GP-023 Change control management
    • GP-024 Predetermined Change Control Plan
    • GP-025 Usability and Human Factors Engineering
    • GP-027 Corporate Governance
    • GP-028 AI Development
    • GP-029 Software Delivery and Commissioning
    • GP-030 Cyber Security Management
    • GP-050 Data Protection
    • GP-051 Security violations
    • GP-052 Data Privacy Impact Assessment (DPIA)
    • GP-100 Business Continuity (BCP) and Disaster Recovery plans (DRP)
    • GP-101 Information security
    • GP-200 Remote Data Acquisition in Clinical Investigations
    • GP-026 Market-specific product requirements
    • GP-110 Esquema Nacional de Seguridad
  • Records
  • Legit.Health Plus Version 1.1.0.0
  • Legit.Health Plus Version 1.1.0.1
  • Legit.Health Utilities
  • Licenses and accreditations
  • Applicable Standards and Regulations
  • Pricing
  • Public tenders
  • Procedures
  • GP-002 Quality planning
  • Templates
  • T-002-003 Quality indicators

T-002-003 Quality indicators

Review details​

  • Record completed by:
  • Record review:
  • Period analyzed:

Indicators scorecards​

Process#IndicatorFrequencyJanFebMarAprMayJunJulAugSepOctNovDecTargetDirectionYearly growthResultsAchievedOwner
Leadership1Quality objectives accomplishment12🔲🔲🔲🔲50%DirectStatic🔲JD-001
Leadership2Employee worktime (avoid overtime)12🔲🔲110%InverseStatic🔲JD-001
Leadership3Employee turnaround12🔲10%InverseStatic🔲JD-001
Design and development4Number of design non-conformities6🔲🔲5InverseStatic🔲JD-005
Design and development5Design inputs/outputs achievement12🔲🔲95%DirectStatic🔲JD-005
Design and development6Number of requirements that fullfill expectations12🔲95%DirectStatic🔲JD-005
Sales7Number of new contracts signed with clients3🔲🔲🔲🔲5DirectStatic🔲JD-002
Sales8Requests to the production API3🔲🔲🔲🔲6,000DirectStatic🔲JD-002
Sales9Increase in sales turnover12🔲🔲🔲🔲220%DirectStatic🔲JD-002
Purchases10Number of non-conformities from suppliers12🔲🔲5InverseStatic🔲JD-001
Purchases11Number of purchases non-conformities12🔲🔲10InverseStatic🔲JD-001
Purchases12Number of discarded suppliers12🔲1InverseStatic🔲JD-004
Quality control16Satisfactory quality control results12🔲90%DirectStatic🔲JD-004
Quality control17Customers who access to software lastest version12🔲66%DirectStatic🔲JD-004
Quality control18Satisfactory software validation results12🔲95%DirectStatic🔲JD-004
Technical assistance19Number of technical assistance incidents12🔲🔲10InverseStatic🔲JD-005
Technical assistance20Number of times that the access to the software has been disabled12🔲🔲5InverseStatic🔲JD-005
Technical assistance21Times we did not meet the Service Level Agreement (SLA) stipulations6🔲🔲3InverseStatic🔲JD-005
Post-market surveillance22Number of communicated incidents to National Competent Authority (NCA)12🔲🔲0InverseStatic🔲JD-004
Post-market surveillance23Number of non-conformities related to the vigilance system or PMS12🔲🔲3InverseStatic🔲JD-004
Post-market surveillance24Number of recalls performed12🔲0InverseStatic🔲JD-004
Operations25Number of data breaches6🔲🔲0InverseN/A🔲JD-003
Operations26Number of infrastructure non conformities6🔲🔲3InverseStatic🔲JD-003
Operations27Expenses increase3🔲🔲🔲🔲10%InverseStatic🔲JD-003
Human resources28Number of training hours per person (at least)12🔲3DirectStatic🔲JD-001
Human resources29Satisfactory training report results12🔲80%DirectStatic🔲JD-001
Human resources30Number of non-conformities related to HR12🔲🔲3InverseStatic🔲JD-001
Quality management31Number of quality non-conformities12🔲🔲8InverseStatic🔲JD-004
Quality management32Number of quality activities performed before the deadline12🔲75%DirectStatic🔲JD-004
Quality management33Number of customer complaints12🔲5InverseStatic🔲JD-004

For every process included in the table above, yearly, a new summary table will be created as follows:

Indicators summary per area​

Process name​

Indicator #
Owner
Name
Target
Direction
Result
Growth
Frequency

Yearly forecast​

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

Indicator number and name​

20212022202320242025202620272028202920302031
Target
Result

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: Team members involved
  • Reviewer: JD-003 Design & Development Manager, JD-004 Quality Manager & PRRC
  • Approver: JD-001 General Manager
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T-002-002 Quality objectives
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T-002-004 Anual management review report
  • Review details
  • Indicators scorecards
  • Indicators summary per area
    • Process name
  • Yearly forecast
    • Indicator number and name
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.)