ISO 13485:2016 – Lead Auditor Training CourseISO 13485:2016 / Lead Auditor Training Course

ISO 13485:2016 - Lead Auditor Training Course
A highly interactive 5-day ISO 13485 Lead Auditor training course enables delegates to plan, lead and report audits within their own organisation, their suppliers and with third party organisations. Our ISO 13485 lead auditor training course will enable you to conduct effective audits in any auditing situation.

Duration - 5 Days

who should attend?

This course is vital for any professional that is involved in implementing and/or auditing quality management systems for medical devices, or those leading a supplier quality assurance program.


A detailed understanding of:

  • Medical devices, quality and auditing terminology
  • Auditing skills
  • Structure & intent of the medical devices standard ISO 13485 :2016
  • Planning, preparation and management of audits
  • Types of audit
  • Checklist development
  • Internal and external audit objectives
  • Conducting process audits
  • Internal audit scope and criteria
  • Reporting audit findings
  • The audit process
  • Verifying corrective action
  • Roles and responsibilities of the internal auditor
  • Interviewing skills
  • Conducting supplier and external audits
  • of the internal auditor
  • Interviewing skills


  • Complying with FDA and CE Marking requirements – the requirements of ISO 13485 and QSR
  • Principles of auditing, the audit cycle and audit objectives
  • Auditing skills and techniques:
    • Planning – use of checklists, resources and timing
    • Selection of audit teams and training
    • Interviewing and evaluation of information and findings
    • Observation – objective evidence
    • Evaluating the significance of nonconformities
    • Communicating and presenting audit reports
    • Corrective actions and effective follow-up programmes
    • Effective improvement – planning, monitoring and results
  • Sources of information and further development
how can we help you?

Contact us via email at [email protected] or submit a business inquiry online.

Thank you for an excellent course which was greatly enjoyed in all respects. It was a real “Crammer” but has undoubtedly fired my imagination as to what can be achieved.

Sue Haworth
Quality Manager, BNFL

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