ISO 13485:2016 Medical Device Quality Management System Implementation Training Course

Our Implementing ISO 13485:2016 two-day course has been designed to provide participants with the knowledge and process steps to enable them to effectively implement a quality management system in line with the requirements for ISO 13485:2016 certification.

The course introduces the concepts needed to understand, develop, and implement a quality management system.


Who should attend?

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

This training course is HRDF approved under the SBL scheme. On completion, you’ll be awarded an internationally recognized BSI Training Academy certificate.

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

How will I 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

Learning method

Our unique accelerated approach fast-tracks learning, improves knowledge retention and ensures you get the skills to apply your knowledge straight away. This course involves practical activities as well as toolkits, templates and classroom learning to help you develop a deeper understanding of the material and have a greater impact on job performance. 

Register for public training Get quotation for in-house training
    o    Suitable for small groups
    o    Suitable for single person
    o    Learn from other organizations
    o    HRDF Claimable
    o    Suitable for large groups
    o    Flexible & convenient
    o    Tailored for your needs
    o    25% - 30% cheaper
    o    HRDF Claimable