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ISO 13485 Internal Auditor Training

Certified Internal Auditor Training Course

Learn how to plan and perform internal audits of quality management systems against the requirements of ISO 13485:2016.

Based on our Exemplar Global certified lead auditor course, this class includes workshops tailored to the changing medical device industry and discussions of auditing techniques and best practices with an increased focus on internal audits. Exercises and workshops feature audit criteria from ISO 13485:2016.

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  • Understand the core concepts of an effective quality system such as process and risk-based approaches.
  • Learn about the ISO 9000 standard series and how ISO 9001:2015, FDA’s
  • Quality System Regulation, and ISO 13485:2016 requirements are related.
  • Explain how to plan and execute an internal audit, as well as conduct follow-up activities using concept detailed in ISO 19011.
  • Describe what third-party assessors look for when they audit your organization.
  • Practice collecting audit evidence and documenting observations – including using techniques for effective questioning and listening – during course workshops.
  • Describe how to verify the effectiveness and adequacy of corrective action, close out an audit, and conduct follow-up surveillance audits.


  • The quality management system
  • Analysis and interpretation of ISO 13485
  • Process and risk-based auditing techniques
  • The quality audit cycle
  • Preaudit activities
  • On-site audit activities
  • Report writing—nonconformity reports
  • Corrective action

Who Should Attend

This is a perfect fit if you will be conducting, managing, or participating in internal (first-party) audits, or helping to develop an ISO 13485 quality system. Also great if you are involved in developing, implementing, and/or maintaining an internal audit system that meets the requirements of ISO 13485.

Exemplar Global-Certification

There are two quizzes during the training and a one-hour, open-book final exam on the last day. For training certification, attendees must meet class participation requirements, pass the quizzes and exam, and attend the full session.

This training course is an Exemplar Global certified course. To attain registration as a QMS Auditor/Senior Auditor/ Lead Auditor, you must pass the written examination, earn a passing grade in the course assessments, and meet prescribed professional requirements.

Exemplar Global requires that all attendees study the current published version of ISO 13485 before attending the class.

Number of Days: 3
CEUs: 2.5
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