ISO 13485 Internal Auditor Training

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In this two-day workshop, you’ll gain the knowledge and skills you need to audit your quality system to the ISO 13485:2016 standard. Course topics include updates the ISO 13485 standard, ISO 13485:2016 requirements, auditing principles, and techniques for conducting effective audits. You'll also get hands-on practice using auditing tools and techniques and have ample opportunities to get answers to questions you have about conducting ISO audits. 


  • Explain the purposes of the ISO 13485 standard.
  • Describe the structure and elements of ISO 13485:2016.
  • Describe the changes included in ISO 13485:2016.
  • Explain what is meant by a "process approach" and what the strategy of a process approach means for organizations.
  • Explain basic principles, techniques, and steps for auditing to ISO 13485.
  • Describe techniques for effectively working with others when conducting audits.

Appropriate for

Personnel involved in conducting or supporting ISO internal audits.


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