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R-003-002 Internal auditor qualification 2023_001

Auditor name​

Fernando Atienza García

Company​

PS Consulting

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 processes9
Quality training3
Quality experience3
MDR 2017/745 training3
Quality audits experience3
Education3
Total score obtained24

Evidences​

Does the internal auditor comply with the minimum requirements?​

  • Yes
  • No

Validity of evaluation: 3 years​

Record signature meaning​

  • Author: JD-004 María Diez
  • Review: JD-003 Taig Mac Carthy
  • Approval: JD-001 Andy Aguilar
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Internal auditor qualification evidence
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R-003-003 Internal audit plan 2023_001
  • 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
    • Evidences
    • Does the internal auditor comply with the minimum requirements?
    • Validity of evaluation: 3 years
  • Record 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.)