ISO 13485:2016 Quality Management Systems for Medical Devices Training Course

ISO 13485:2016 Quality Management Systems for Medical Devices Training Course

ISO 13485 (ISO 13485:2016) is the  internationally recognised quality management systems standard for the medical device industry.

Come along to the training and learn about the key changes in the latest 2016 edition:

  • Applicability to the complete life cycle of the product (from design to distribution to support)
  • Changes to infrastructure requirements
  • Embedding risk management and risk based decision making throughout your quality management system
  • Increasing requirements for validation, verification, and design activities
  • Increasing vigour around supplier control processes
  • Harmonisation of global regulatory requirements
  • Adding increased feedback mechanisms and expectations for post-production monitoring
  • More explicit requirements for software validation for different applications


This full-day course covers the key concepts of the Quality Management System (QMS) including the changes in the 2016 release of ISO 13485, and how to apply these to the sponsorship and manufacture of medical devices (including In-Vitro Devices).

We regularly offer GMP training courses and events in Adelaide, Auckland, Brisbane, Hong Kong, Melbourne, Perth and Sydney, or in other countries on an as-needed basis.

What you will learn

Upon completion of this on ISO 13485:2016 Quality Management Systems for Medical Devices course participants will be able to:

  • understand the changes in the 2016 release of ISO 13485
  • understand the requirements for a Quality Management System for the manufacture of medical devices
  • plan and develop the documentation required to support the QMS and
  • understand what the auditor will look for during a regulatory or notified body audit.

Course materials

Participants will receive a copy of the presentation(s), relevant notes and workshop materials. A certificate of completion will be issued to participants who successfully complete the assessment.


A written assessment is conducted at the end of the course.

Course format

The ISO 13485:2016 Quality Management Systems for Medical Devices Training Course is a combination of lecture-style learning and active workshops, with participants working in small groups on assigned tasks and case studies.

Who should attend?

  • Quality Assurance personnel
  • Quality Control personnel
  • Operations and Manufacturing personnel
  • Qualification/Validation personnel
  • Anyone within the medical device industry interested in learning about or improving their knowledge of the requirements for the manufacture of medical devices.

AUD $450.00 + 10% GST

Prices are per person and include morning tea, lunch and afternoon tea

Register for an ISO 13485 Quality Management Systems Training Course below:

If you need any assistance, would like a quote for personalised group training, or just have a general training question don’t hesitate to contact us.

Event Venue Date
Quality Management Systems - ISO13485 Training - Virtual Virtual Training
  • 25/11/2020 9:00 am