introduction to ISO 13485

Training Course


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.

Course Type

  • Classroom
  • In-house

Who should attend?

  • Who wants an overview and an understanding of the intent and requirements of ISO 13485:2016, and its compatibility with other management systems
  • Who wants to convert from ISO 9001 to ISO 13485:2016

  • Who wants to create a single QMS that meets global regulations.

What will you 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 do you need to prepare

No previous experience needed.

Course Length

One day

What is included

  • Exemplar Global Approved Certificate

  • 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.

This WECERT‘s training course satisfies the formal training requirements stipulated by the Exemplar Global.

Exemplar Global certified training is mapped to a unique competency framework based on the latest skills needed by employers. As an Approved Training Partner, WECERT has been thoroughly assessed to ensure the highest standards.

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