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Introduction

Learn how to design and implement an effective Quality Management System (QMS) based on ISO 13485:2016.

Applicable for those preparing for ISO 13485 certification or those looking to improve the effectiveness of their current management system.

Who should attend?

  • Individuals responsible for their organization's ISO 13485 based Quality Management System
  • System managers who may in the future be involved in managing an ISO 13485 based Quality Management System.

What will you learn?

  • To implement a QMS based on ISO 13485:2016
  • To develop a quality policy and objectives
  • The need for documenting systems, processes and typical methods
  • Key features of risk assessment
  • Importance and relevance of legislation
  • Design requirements
  • The significance of process and environmental controls (e.g. clean rooms, sterilization, personnel controls)
  • Plan and manage your internal quality auditing activities
  • Eliminate the causes of problems through effective corrective action
  • Develop an appropriate management review process and implement processes for improving the effectiveness of the system.

What do you need to prepare?

Knowledge of QMS fundamentals.

What’s included?

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

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

ISO 13485:2016 Internal Auditor.

Course length

Two days.

Contact us to learn more about ISO 13485 certification training.

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.

Book now View dates & locations

Prices from


Course Type

  • Public
  • In-house

Course length

In-house

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.

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