ISO 13485:2016 Lead Auditor

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In this comprehensive course, participants will gain an in-depth understanding of the ISO13495:2016 and ISO19011 standards and their application in the Medical Device Industry. Through a combination of lectures, practical exercises, and case studies, participants will become proficient as ISO13485:2016 Lead Auditors.

Key topics covered in the course include:

  • ISO13485:2016 Standard
  • Principles of Auditing – ISO 19011
  • Audit planning, preparation, and execution
  • Documentation review and assessment
  • Audit reporting and corrective action follow-up
  • Ethical considerations and professional conduct in auditing
  • Conflict resolution during an audit
  • Leading Audit Teams
  • Case studies and real-world examples
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