Contact Us
Search Icon

Suggested region and language based on your location

    Your current region and language

    ISO 13485:2016 Requirements On-demand eLearning

    ISO 13485:2016 Requirements On-demand eLearning

    Level Requirements Duration 4 hours
    Available to book: On-demand elearning Book your place

    This course explores the requirements of the ISO 13485:2016 Quality Management System standard, discussing key principles and how the standard interacts with ISO 9001:2015 and also it serves to facilitate global alignment for Medical Device quality management systems.

    E-Learning - training that’s even more flexible

    If you need to understand the requirements of this ISO 13485:2016 quality management system standard and are confident enough not to need tutor-led training, this online, self-paced course offers you complete flexibility.

    You can study in your own time when it suits you, and you can access the course from any internet-enabled device 24/7.

    How will I benefit?

    This course will help you:

    • Take the first steps towards ISO 13485:2016 certification
    • Understand how you can better meet regulatory requirements leading to increased patient safety
    • Find ways to increase efficiency and cost savings through quality management
    • Monitor supply chains to achieve continuous improvement
    • Develop safe and effective medical devices
    • Motivate employees through CPD
    • You will learn about:

      • Gain an appreciation for the origins of ISO13485
      • Understand the use of ISO13485 as the basis for a Quality Management
      • System for Medical Device organisations
      • Awareness of the key differences to the ISO9001:2015 standard
      • Appreciate the process approach concept of the standard and the Plan-Do-Check-Act (PDCA) framework
      • Knowledge of the overall structure of ISO 13485:2016
      • Recognize the key clauses of the ISO 13485:2016 standard
    • Senior management, quality managers, regulatory affairs managers, internal and external auditors, consultants and anyone involved with the implementation of the standard.

      • This is an online, interactive eLearning course.
      • You’ll have access to the course for 12 months.

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

    • Click here to register for ISO 13485:2015 Introduction Exam only.

    Contact Us

    Let's shape your organization's future together

    Reach out and see how we can help guide you on your path to sustainable operational success.

    Get in touch