ISO 13485:2016 Internal Auditor

This intensive two day course is intended for medical device quality professionals aiming to build on their knowledge of ISO 13485:2016 and evaluate the effectiveness of the quality management system in their organization.

Learn the principles and practices of effective quality management systems process audits in accordance with the ISO 13485:2016 and ISO 19011:2018.

An experienced instructor guides students through the internal audit process, from planning an audit to reporting on audit results and following up on corrective actions. Participants will gain necessary auditing skills through a balance of formal classroom tutorials, practical role-playing, and group workshops.

Who should attend?

  • Medical device quality professionals with knowledge of quality management systems and ISO 13485:2016
  • Individuals interested in conducting first-party or second-party audits
  • Management representatives
  • Internal auditors
  • Managers
  • Consultants

Learning objectives

  • Explain the structure and scope of the ISO 13485:2016 management system standard and how it applies to the organization aiming for regulatory compliance worldwide
  • Identify the principles of auditing and auditor responsibilities
  • Plan an internal audit
  • Conduct informal opening and closing meetings
  • Conduct an audit based on process identification sampling and questioning
  • Provide verbal and written feedback
  • Document coincide non-conformities
  • Effectively report on an audit
  • Follow-up on corrective actions

Course Benefits

  • Learn how to audit for medical devices
  • Understand the audit process
  • Improve your understanding of medical devices best-practice
  • Improve your understanding of the international requirements for medical devices
  • Be better able to continue compliance with ISO 13485:2016
  • Maintain and improve a global benchmark in quality standards 
  • Be confident that your organization can rely on ISO certified internal auditors
  • Motivate colleagues and build customer confidence


Delegates who attend this course must already have a detailed knowledge of ISO 13485:2016 and ISO 9001:2015. For those who don't, we recommend attending the following courses beforehand: