You need this course if...
- You are responsible for managing an ISO 13485:2003/EN ISO 13485:2012 based Quality Management System
- You own or manage Quality Management System processes in your organization
- You are an Internal Auditor of an ISO 13485:2003 / EN ISO 13485:2012 based Quality Management System
- You require an understanding of the extent and nature of the changes in this revision of ISO 13485:2016 in order to facilitate a smooth transition and raise awareness of the changes and the preparation needed within your organization.
You will learn...
- The principal changes introduced in ISO 13485:2016, together with the new and enhanced requirements, in order to recognize to what extent your Quality Management System requires adapting
- The differences between ISO 13485:2003/EN ISO 13485:2012 and ISO 13485:2016;
How long a transition period you have before the changes become mandatory.
You will need...
- To possess some knowledge of the current ISO 13485:2003/EN ISO 13485:2012 requirements
- To possess some knowledge of ISO 9001:2008.
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
Half day in-house only.
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.