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Introduction to ISO 13485:2016.

Thinking about implementing ISO 13485?


This one day, introductory course provides an overview of ISO 13485:2016, and promises to give delegates an understanding of the intent and the requirements for ISO 13485:2016 quality management systems (QMS).

You can choose whether to attend our ISO 13485:2016 Appreciation and Interpretation as a public or as an in-hourse event. Our public courses allow delegates to interact and network with other delegates from various medical devices companies and appreciate how other organisations have interpreted and implemented the ISO 13485 standard. As an in-house event, the course content can be tailored to your own orgaisations management system and can be delievered on a date that suits you.

Who should attend?

This introductory course is relevant to anyone, of any level, involved with an ISO 13485:2016 management system who wishes to learn more about the standard and who:

  • Wants an overview and an understanding of the intent and requirements of ISO 13485:2016, and its compatibility with other management systems
  • Wants to convert from ISO 9001 to ISO 13485:2016
  • Wants to create a single QMS that meets global regulations.

What will I learn?

  • The scope and application of the ISO 13485:2016 standard
  • The differences between ISO 13485:2003 and ISO 13485:2016
  • Essential definitions and terminology to help you interpret and apply ISO 13485:2016 requirements
  • The key requirements of ISO 13485:2016 and how they relate to each other to form a robust, effective system
  • The relationship between ISO 13485:2016 and the risk management standard ISO 14971.

What’s included?

  • 7 CPD hours on completing the course
  • Training presentation and slides as a course hand-out
  • Certificate of attendance
  • Lunch and refreshments
  • Pen and notepad.

Training from LRQA

With LRQA, you can access a wide range of courses to help you further your career and bring improvements to the management systems in your organisation. With many learning styles to choose from, our training courses can help you develop and reach your next level.  Find out more about our Training Courses from LRQA.


If you are looking for a course for four or more people, you may find our in-house option more cost-effective. Contact the team for a quote.