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Overview

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 course or as an in-company event. Our public courses allow delegates to interact and network with other delegates from various medical devices companies and appreciate how other organizations have interpreted and implemented the ISO 13485 standard. As an in-company event, our ISO 13485:2016 experts come to you. Our ISO 13485: 2016 Appreciation and Interpretation course can be tailored to your organization’s own management system and run at a date and time to suit 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.

Course length

One day.

Training from LR

With Lloyd's Register, you can learn in the way that works for you. We offer courses in a range of styles, from in-house to virtual classroom. Find out more about Ascend Training Courses from Lloyd's Register. 

Your future development

Certification with Exemplar Global

For an additional $99 USD you can also obtain an Exemplar Global Course Certification for your course.

What are the advantages of adding the Exemplar Global Certification?

With the additional Exemplar Global Course Certification, you will get access to:

  • The Exemplar Global Work Style Behavioural Assessment
  • One-Year Graduate Certification
  • Use of Exemplar Global’s brands and logo to promote your certification
  • Access to Exemplar Global Webinars and Online events
  • Access to Exemplar Global online resources, including Auditor OnLine and regular Job Board notifications
  • Access to the social community of graduates
  • An innovative, continual learning environment for learners and graduates
  • Ongoing support for an entrepreneurial career track for graduates and learners

How to add Exemplar Global Certification to your training course?

If you're booking online, you can add the option of Exemplar Global before you proceed to checkout or contact our team directly.

Register interest

Course Type

  • Public
  • In-house

 

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