Introduction to ISO 13485:2016

Gain a better insight into the use of ISO 13485:2016 as the basis for a Quality Management System (QMS) implemented by medical device manufacturers.

This course explores the requirements of the ISO 13485:2016 Quality Management System standard, discussing key principles and how the standard interacts with ISO 9001:2015, the European Medical Device Directives and US FDA’s Quality System Regulation.


Who should attend?

  • Senior Management
  • Quality Managers
  • Regulatory Affairs Managers
  • Internal and external Auditors
  • Consultants
  • Anyone involved with the implementation of the ISO 13485:2016 standard 

Learning objectives

On completion, you should gain the knowledge and skills to:

  • Explain the use of ISO 13485:2016 as the basis for a QMS for medical device manufacturers
  • Identify the relationship between ISO 13485:2016 and European Medical Device Directives
  • Recognize the use of ISO 13485:2016 as the basis of regulatory requirements worldwide

Course Benefits

This course will help you:

  • Take the first steps towards ISO 13485:2016 certification 
  • Understand how you can better meet regulatory requirements leading to increased patient safety
  • Find ways to increase efficiency and cost savings through quality management 
  • Monitor supply chains to achieve continuous improvement
  • Develop safe and effective medical devices 
  • Motivate employees through CPD

What will I gain?

On completion, you’ll be awarded an internationally recognized BSI Training Academy certificate.


Express your interest

Contact our training experts and we will discuss your needs with you.

Request an in-house training quote

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