Implementing ISO 13485:2016

Develop your knowledge and skills in the process of implementing ISO 13485:2016 within an organization that provides medical devices or services to support medical devices.

You’ll be introduced to the concepts needed to understand, develop and implement a Quality Management System (QMS). This course provides the knowledge and process steps to enable the effective implementation of a QMS that is in line with the requirements for ISO 13485:2016 certification.


Anyone involved in defining, planning, or implementing an ISO 13485:2016 QMS, as well as management representatives and implementation team members.

What will I learn

On completion, you should gain the knowledge and skills to:

  • Define a quality management system
  • Identify the steps for defining, planning, organizing and scheduling necessary activities
  • Implement an effective quality management system

Conduct a base line review of an organization's current position with regard to ISO 13485:2016

Our high impact accelerated learning approach increases learning by improving knowledge retention and skill application. This course is activity-based, resulting in a deeper understanding of the material and a greater impact on job performance.

Who will benefit

This course will help you:

  • Understand how to implement a QMS as required by medical device directives
  • Plan the implementation of ISO 13485:2016 within your organization
  • Take the first steps towards ISO 13485:2016 certification
  • Identify how you can better meet regulatory requirements
  • Find ways to increase efficiency and add value through quality management

Monitor supply chains to achieve continuous improvement

What is included

On completion, you’ll be awarded an internationally recognized BSI Training Academy certificate.

Book your place

    Detailed course notes and lunch provided.

    Schedule: 9am-5pm

    You may also be interested in attending our ISO 13485:2016 Introduction or Clause by Clause courses.