ISO 13485 Internal Auditor Practitioner Qualification

For those with some existing knowledge of the ISO 13485:2016, undertaking this first step on the auditor qualification pathway will boost your understanding and skills to help you fully grasp and comply with the standard as an Internal Auditor Practitioner. Guided by expert BSI trainers, you’ll learn how to write comprehensive audit reports in line with ISO 13485:2016 Quality Management System (QMS) and discover how the standard helps global alignment for Medical Device QMS.

Whether you’re a member of senior management, a regulatory affairs or quality manager, internal or external auditor, you can help everyone in your organization to fully understand the importance of the standard and how to identify the key differences from the ISO 9001:2015.

How will I benefit?

  • Gain the knowledge you need to find ways to increase efficiency and cost savings in your organization
  • Learn how to develop safe and effective medical devices
  • Understand how to conduct an effective audit based on process identification, sampling and questioning
  • Achieve formal recognition of your knowledge and ability to directly apply your skills in your organization
  • Continue advancing your career progression and get access to a wider range of higher-level and more advanced specialized qualifications
  • Enter a global community qualified professionals to share experiences and practical advice to use in your everyday life

Which qualification will I achieve?


On successful completion of your qualification, you’ll receive a BSI Mark of Trust that can be shared across within your organization and across your network of contacts.