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    ISO 13485:2016 Implementation Training Course - International

    ISO 13485:2016 Implementation Training Course - International

    Nivel Implementación Duración 2 Días
    Disponible para reservar: Formación aula virtual €900 IVA Book your place

    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.

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

     

    How will I benefit?

    • Understand how to implement a QMS as required by medical device directives
    • Plan the implementation of ISO13485:2016 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.
      • 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
    • Anyone involved in defining, planning, or implementing an ISO 13485:2016 QMS, as well as management representatives and implementation team members.

      Prerequisites:

      You should have a good knowledge of ISO I3485:2016 and the key principles of a QMS. If not, we strongly recommend you attend our ISO 13485:2016 Introduction training course.

      • It's a 2-day course
      • The training and materials will be provided in English
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