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Introduction to ISO 13485.

Thinking about implementing ISO 13485?


This introductory course provides an overview of ISO 13485:2016 and gives delegates an understanding of the intent and the requirements for ISO 13485:2016 quality management systems (QMS) for manufacturers of medical devices.

Who should attend?

  • Individuals, of any level, involved with an ISO 13485:2016 management system who needs an overview of the intent and requirements of the standard
  • Those involved with ISO 13485:2016 who need to create a single Quality Management System.

What will you learn?

  • Scope and application of the new standard
  • The differences between ISO 13485:2003 and ISO 13485:2016
  • Essential definitions and terminology
  • Key requirements of ISO 13485:2016 and how they relate to each other to form a robust, effective system
  • The relationship between the standard and the risk management standard ISO 14971.

What do you need to prepare?

No previous training or knowledge is required to attend this course.

What's included?

  • 7 CPD hours
  • Training course materials
  • Lunch and refreshments for public attendees only
  • Certificate of attendance.

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.