Designed by your partner in learning as an intensive course for medical device quality professionals, this ISO 13485 internal auditor training builds knowledge for an effective quality management system.  

The two-day training is delivered either in person or live online in a classroom environment. Guided by experienced instructors, you will learn how to explain the structure and scope of the standard and identify an auditor’s key responsibilities. You’ll also discuss every stage of the internal audit process through role-play, workshops and tutorials, plan and conduct an audit and assess if it was done effectively. 

Although some prior understanding of ISO 13485:2016 is useful, you’ll leave the course with all the knowledge you need. You’ll be able to maintain compliance and internal processes and motivate colleagues to do the same.   

Course Duration: 2 Days
Delivery Method: Online

What will I learn?

On completion of this training, participants will be able to:

• Explain the structure and scope of ISO 13485:2016 and how it applies to the organization seeking regulatory compliance

• Identify the key principles of auditing and auditor responsibilities

• Plan an internal audit

• Conduct an effective audit based on process identification, sampling and questioning

• Determine if corrective action has been effectively implemented.