ISO 13485 Foundation Course

This one day ISO 13485 Foundation Course will give you a detailed understanding of the 2016 version of ISO 13485, the quality management system used for the medical device industries.

The ISO 13485 Foundation Course has been developed to help those working in the medical devices industry to get an understanding of quality management systems that meet the requirements of the ISO 13485 standard.

This one day course will explain in detail why and how ISO 13485 is used and it’s links to other quality management systems like ISO 9001. It is a suitable course for any person who is or plans to become involved in the maintenance and management of an organisations quality management system and is an ideal starting point in the career of any prospective quality manager working within the medical devices industry.

Who should attend?

The ISO 13485 Foundation Course is aimed at any person that plays a role in maintaining a company’s medical device quality management system. It is also an ideal starting point in the career of any prospective quality manager within this industry as well as other members of senior management or the auditing team.

Course outcome

By the end of this ISO 13485 Foundation Course, delegates will be able to:

  • Understand the basic requirements of ISO 13485 and how they apply to processes within your organisation
  • Start the process of implementing a QMS designed specifically for an organisation within the medical device industry
  • Understand the benefits of adopting ISO 13485 within your organisation

What’s included?

We provide all course materials and certificates of attendance for each delegate completing the ISO 13485 Foundation Course. Public courses include lunch and refreshments throughout the day.

Course Information


Contact us for a quote.

Course duration

1 day

Course content

This one day course consists of a mixture of presentations and group exercises and will cover the following key topics;

  • The history of ISO 13485 and quality management systems for the medical devices industry
  • Key clauses and requirements in the ISO 13485 standard
  • The processes & procedures that are required in order to meet the ISO 13485 standard’s requirements
  • The relation between ISO 13485 and ISO 9001
  • Annex SL Requirements
  • How the assessment process works
  • The process approach

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Full 1
"Robert was very informative and did an excellent job of running the course whilst adapting well to cover the needs of our mixed experience audience. I'd like to thanks the whole team for all your support throughout this project."

Head of Quality - Aero Tec Ltd

Full 2
“We want to thank the trainer for sharing his experience and challenging us, sometimes pushing us out of our comfort zone. We can appreciate why this was done and the benefits it will bring to our business.”

HSEQ Director - Altrad Group

Full 3
“The course was excellent. Paul kept everyone engaged throughout and ensured that everyone understood each particular topic before moving on. I really enjoyed the course and would recommend 3TL Training to others.”

Compliance Manager - Office for National Statistics

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