ISO 13485:2016 Foundation

ISO 13485 is the standard specific to quality management systems to ensure regulatory compliance for medical devices.

This practical and interactive 1-day course can help you to understand the key requirements of ISO 13485, what an effective Quality Management System should look like and how this can be applied to your organisation.

Course Cost

Early Bird Price £295 + VAT

Two For Less Price £545 + VAT

Available as In house course'

Upcoming Courses

Monday 01 June 2020
Monday 06 July 2020
Wednesday 02 September 2020
Monday 26 October 2020

  • How to cut through the ‘ISO speak’ to give you a practical understanding of ISO 13485:2016.
  • Destroying the myths of system documentation — what you actually need to run your system.
  • Key System Elements: How to implement ISO 13485 into your business, not your business into ISO 13485.
  • The links between ISO 13485 and the Medical Device Directive and CE Marking.

This course is for anyone who wishes to gain an insight in to how ISO 13485 and quality management systems can be applied to medical device manufacture. It may be that you are considering the application of ISO 13485, have been given responsibility for quality management or just need to have an understanding of the system to do your job. The course is also recommended for delegates who are about to attend one of our medical device auditor courses.

This course will give you a good practical understanding of quality management systems and ISO 13485:2016. Completion of the course will help you and your organisation to identify gaps in your quality management system as a basis for improvement, helping you to maintain your regulatory compliance and system effectiveness. Our experienced trainers will also guide you through ISO 13485:2016 so that you have a clear understanding what it is your certification body is looking for the next time they audit.

Learning becomes easier and more effective if you, as a delegate, feel more involved and participate! We lead the training experience but also encourage thought, analysis and involvement to ensure you gain greater insight and understanding.


To speak with one of our training experts, you can call us on...
01236 734447

Early bird discounts are obtained by reserving a place and paying the discounted fee at the time of booking or invoice date. Two for less discounts are available for two or more people from the same organisation attending the same course, making the reservation at the same time and paying the discounted fee by the invoice date. For all discounts no cancellation refunds are available but transfer may be possible with at least 15 days notice.

IRCA Recommends

"An essential pre-requisite to internal auditor and lead auditor training. This course will give delegates an underpinning knowledge of the management systems and the requirements of the management system standards. This course is recommended for delegates who require a general understanding of the requirements of the standard."