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QMS
  • Welcome to your QMS
  • Quality Manual
  • Procedures
    • GP-001 Control of documents
    • GP-002 Quality planning
    • GP-003 Audits
      • Templates
        • T-003-001 Audit program_YYYY_nnn
        • T-003-002 Internal auditor qualification
        • T-003-003 Internal audit plan
        • T-003-004 Internal audit checklist
        • T-003-005 Internal audit report
    • GP-004 Vigilance system
    • GP-005 Human Resources and Training
    • GP-006 Non-conformity, Corrective and Preventive actions
    • GP-007 Post-market surveillance
    • GP-008 Product requirements
    • 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 Software validation plan
    • GP-020 QMS Data analysis
    • GP-021 Communications
    • GP-022 Document translation
    • GP-023 Change control management
    • GP-024 Cybersecurity
    • GP-025 Corporate Governance
    • 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
  • Records
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  • Procedures
  • Records
  • Procedures
  • GP-003 Audits
  • Templates
  • T-003-002 Internal auditor qualification

T-003-002 Internal auditor qualification

Auditor name​

Company​

Mínimun Skills​

  • Good interpersonal Skills
  • Analytical capacity
  • Organizational and planning Skills

Minimum requirements​

  • Knowledge on ISO 13485 and/or ISO 9001.
  • Quality experience.
  • Knowledge of internal processes.
  • Training on MDR 2017/745.

Evaluation criteria​

Knowledge of internal processes​

  • > 3 years: 10 points
  • 2 - 3 years: 9 points
  • 1 - 2 years: 8 points

Quality training​

  • Quality Management Systems training: 3 points
  • ISO 9001/ ISO 13485 training: 2 points
  • Basic quality training: 1 point

Quality experience​

  • > 10 years: 3 points
  • 9 - 7 years: 2 points
  • 6 - 3 years: 1 points

MDR 2017/745 training​

  • Training by NB: 3 points
  • Training by a different entity than NB: 1 point

Quality audits experience​

  • > 4 audits: 3 points
  • 2-4 audits: 2 points
  • 1 audit: 1 point

Education​

  • Academic education: 3 points
  • High school: 2 points
  • Primary education: 1 point

Internal auditor evaluation​

Minimum score to be considered qualified: ≥ 24

SkillScoring
Knowledge of internal processes
Quality training
Quality experience
MDR 2017/745 training
Quality audits experience
Education
Total score obtained

Does the internal auditor comply with the minimum requirements?​

Yes ⬜️
No ⬜️

Validity of evaluation: 3 years​

Record signature meaning​

  • Author: JD-004 Author name
  • Review: JD-005 Reviewer name
  • Approval: JD-001 Approver name

Template signature meaning​

info

Delete this section when you create a new record from this template.

  • Author: JD-004 María Diez
  • Review: JD-005 Alfonso Medela
  • Approval: JD-001 Andy Aguilar
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T-003-001 Audit program_YYYY_nnn
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T-003-003 Internal audit plan
  • Auditor name
  • Company
  • Mínimun Skills
  • Minimum requirements
  • Evaluation criteria
    • Knowledge of internal processes
    • Quality training
    • Quality experience
    • MDR 2017/745 training
    • Quality audits experience
    • Education
  • Internal auditor evaluation
    • Does the internal auditor comply with the minimum requirements?
    • Validity of evaluation: 3 years
  • Record signature meaning
  • Template signature meaning
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.)