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    Implementing ISO 13485:2016 Training Course

    Implementing ISO 13485:2016 Training Course

    Level Implementation Duration 2 days
    Available to book: Instructor led training £1530 + VAT Akamai View dates and book now

    This two-day course gives you the knowledge and steps to implement a quality management system (QMS) in line with ISO 13485:2016. It’s suitable for managers or members of an implementation team. 

    Choose to take this stage of your learning journey in-person or live online in a classroom environment. You’ll learn how to plan, organize and schedule everything needed to define an ISO 13485: 2016 QMS, as well as how to implement it. You’ll also carry out a baseline review, specific to your own organization.  

    On completing the course you’ll gain a certificate and 16 CPD points. The training helps you to generate your own comprehensive course notes and will leave you with a thorough understanding of how to implement the ISO 13485:2016 standard. 

    How will you benefit?

    • Understand and plan ISO 13485:2016 implementation
    • Find ways to increase efficiency, add value and monitor supply chains effectively
    • Take the first steps towards ISO 13485:2016 certification
    • Gain a recognized certificate and 16 CPD points

    • On completion of this training, participants will be able to:

      • Define a ISO 13485:2016 QMS
      • 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
      • Anyone involved in defining, planning, or implementing an ISO 13485:2016 based quality management system
      • Management representatives
      • Implementation team members

    • We are:

      • A full scope Notified Body
      • A full scope UK Approved Body
      • A national Standards Body
      • An accredited ISO 13485 Certification Body
      • A recognized Auditing Organization under the Medical Device Single Audit Program
      • A globally recognized Certification Body
      • You will gain 16 CPD points on completing the course
      • Certificate
      • Training course notes
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