ISO 13485 Training courses

ISO 13485 is an international certification standard that defines quality management system requirements for manufacturers of medical devices.

LRQA’s medical assessors and trainers have some of the most extensive ISO 13485 experience in the world, and many are hand-selected to provide their input to ISO technical committees and the panels reviewing the EC medical device directives.

LRQA’s ISO 13485 training courses are designed to support your organisation no matter what stage you are at with your management system. Whether you are looking for an ISO 13485 introductory course to learn of the key requirements of the standard, looking to implement an ISO 13485 management system, carry out an internal audit to ISO 13485, or transition to the new ISO 13485:2016 standard, then LRQA will have a course for you. 

All of our courses are available as public courses that you can book online, or as in-house, customisable courses that can be delivered at your own premises at a date and time that suits you.

ISO 13485:2016 Courses

ISO 13485:2016 Update Workshop

This half-day course covers the principal changes introduced in ISO 13485:2016, together with the new and enhanced requirements, the differences between ISO 13485:2003 / EN ISO 13485:2012 and ISO 13485:2016, so that you can recognise to what extent your Quality Management System requires adapting.

Preparing for ISO 13485:2016

This comprehensive, one-day course is designed for those who are responsible for managing the transition of their management system and who want to learn about the latest requirements of the ISO 13485:2016 standard.

ISO 13485:2016 Appreciation and Interpretation

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).

ISO 13485:2016 Implementation

This two-day ISO 13485:2016 Implementation course is for those who want to design and implement an effective QMS based on ISO 13485:2016, for companies who are preparing for ISO 13485 certification or those that are looking to improve the effectiveness of your current management system.

ISO 13485:2016 Internal Auditor

This two-day ISO 13485:2016 Internal Auditor training course is for those that want to add value to their organisation, improve the effectiveness of the QMS and understand the best practices to conduct an effective internal QMS audit in accordance with the requirements of ISO 13485:2016.

ISO 13485:2016 Auditor/Lead Auditor

This four day course is designed to give you a detailed understanding of the role and responsibilities of an Auditor or Lead Auditor, covering topics including audit processes and planning, gathering objective evidence and evaluation of audit findings.