ISO13485:2016 – from an auditing perspective

This one day online-course provides you with a full understanding of the requirements ISO13485:2016 place on your Quality Management System, as well as the solutions recommended in the 13485 Handbook.

Course description

  • How can I audit things like “process performance” “change control” and “risk-based approach”?
  • How can I verify that applicable national regulations are identified and implemented?
  • How do I ensure my 13485 certified-quality system is both compliant and efficient?
  • What exactly is a “Quality Plan” and how should they be documented?
  • The Management Review is one of the most important QMS tools, how can it become more engaging and how do I ensure the input and output is relevant and useful?

After this course you will be equipped to tackle the questions above. We’ll walk you through the key ISO13485:2016 requirements on the Medical Device quality management systems and provide you with tools to perform an efficient audit of your quality system, or to review and improve your own quality system.

Course outline

In this course you will learn how to

  • Understand the relationship between ISO3845:2016 and national regulations
  • Be fully equipped to audit your internal quality management system against ISO13485

Learning objectives

Completion of this course will give you the knowledge needed to assess or audit the quality management system of your own organisations, or 3rd party (like suppliers, against all aspects of IO13485:2016.

Who should attend

The course is suitable for persons who need to implement, maintain or audit a Medical Device Quality Management System that need to demonstrate compliance towards ISO13485:2016.


  • You should have basic knowledge of quality systems, e.g. by participating in one of our basic courses or have equivalent knowledge of the company’s internal quality assurance programs.
  • You should have at least 6-12 months experience of working in the regulated industry (medical device or pharmaceutical industry).



IndustryMedical Device

Åse Ek