EN ISO 13485:2016
Internal Auditor

Course Outline One unique aspect of working in medical device manufacture is that it has its own specific quality management system, EN ISO 13485:2016. This goes beyond the standard EN ISO 9001 in a number of ways, and requires specialist skills. One of the key requirements for running and maintaining an EN ISO 13485 compliant quality management system is having a programme of internal audits. This course is designed to provide internal auditors with the specific training they need to work in an EN ISO 13485 environment. It’s suitable for new and trainee internal auditors, as well as those who are trained to 9001 but need to take their knowledge further. And it will give you the tools and confidence to handle the different approach required for internal auditing in a regulated environment. By the end of this practical and interactive course, delegates are able to plan, conduct, report and follow up an internal audit, and evaluate any corrective and preventive actions arising from the audit. In addition to teaching the EN ISO 13485 standard itself, the course explains how it integrates with other regulations and quality management systems, including the Medical Devices Directive and the FDA’s 21 CFR 820 system.

Topics covered include

  • Overview of EN ISO 13485 standard including definitions and terms
  • Cross linking to other regulations
  • The types of audits
  • Preparing an Audit Schedule
  • Identification of key auditor skills and Auditing Techniques
  • Planning a process based audit including resources and timings
  • Checklists – development and uses
  • Evaluating the significance of audit findings
  • Audit Reports


  • A detailed, usable appreciation of the requirements for internal auditing
  • Understanding of EN ISO 13485
  • Have the skills required to plan, conduct, report and follow-up on internal audits
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