ISO 13485: 2016 – Quality Management Systems

PO1603: ISO 13485: 2016 – Quality Management Systems

This ISO 13485:2016 training course covers the basic requirements of ISO 13485 and its implications within a medical device manufacturing company. PharmOut’s consultants regularly design and write Quality Management Systems for companies, from the smallest to the large blue chip companies. They have many practical suggestions on how to apply the ISO 13485 standard and with ready access to ex TGA inspectors can answer the more difficult questions too.

As the ISO Standard 13485:2016 Medical Devices states;

“All requirements of this International Standard are specific to organizations providing medical devices, regardless of the type or size of the organization.”

Course Duration & Location

One day, on your site or at an offsite location.

PharmOut’s training courses can be delivered anywhere in the world, we will ask you to cover reasonable travel costs, with this you will save the costs associated with your staff travelling to an external venue to be trained, so it becomes cost effective if you have several people needing training.


Our 2018 pricing is A$350 per person or A$3500 per day plus GST for up to 15 participants. This does not include travel costs.

*Smart device and WiFi is needed for all attendees.

Contact us for a quote if you need more that 10 trainees to be trained.

What you will learn

Upon completion of this course participants will be able to;

  • understand the definition of a Medical device and what ‘intended use’ actually means for 13485 compliance
  • understand the intent and scope of the 13485 standard
  • have a practical, working knowledge of the 13485 and people’s responsibilities in maintaining compliance with this Standard
  • know how to practically implement the fundamentals of 13485
  • realise the importance of 13485 compliance
  • understand the processes that drive the 13485 Standards
  • implement documentation regulations for procedures, work instructions and records

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 course is a combination of lecture-style learning and active workshops with participants working in small groups on assigned tasks.

Who should attend?

  • Operations / Manufacturing personnel
  • Quality Assurance personnel
  • Quality Control personnel

More information

If you would like a quote or would need to ask questions, please contact us.

Public training courses and events

Register for Medical Device ISO 13485:2016 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
Melbourne Quality Management Systems - ISO13485 Training Canterbury International Hotel
  • 05/06/2019 9:00 am
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