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    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.

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