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    ISO 13485:2016 Clause by Clause Training Course

    ISO 13485:2016 Clause by Clause Training Course

    Level Requirements Duration 2 days
    Available to book: Virtual classroom View dates and book now

    This two day course has been designed to provide an in depth understanding of ISO 13485:2016.

    On completion of this training, participants will be able to apply their knowledge to the development of a ISO 13485:2016 compliant quality management system and help maintain on going certification of their organization.

    How will I benefit?

    • Describe the requirements and structure of ISO 13485:2016
    • Interpret and apply requirements relevant to your organization
    • Appreciate how a QMS can be applied as a framework to produce safer medical devices
    • Evaluate how requirements can be effectively implemented to meet and maintain regulatory compliance
      • Explain the scope and the structure of ISO 13485:2016
      • Describe the requirements of ISO 13485:2016
      • Explain how to interpret the requirements of the standard within your organization
      • Develop your knowledge of how the requirements of ISO 13485:2016 are established and maintained in an organization
      • Identify the systems that are required to implement an ISO 13485:2016 QMS in order to gain or maintain certification to ISO 13485:2016
      • Regulatory, quality, research, design, development, and manufacturing personnel who will be involved in working with ISO 13485:2016 and need to have a greater understanding of the management system
      • Organizations preparing to put ISO 13485:2016 in place
      • Personnel who have joined an organization who have ISO 13485:2016 and require in depth knowledge
      • Delegates attending the Lead Auditor to ISO 13485:2016 course who do not already have a good knowledge of the standard
      • Delegate workbook
      • Lunch and refreshments (Applicable for classroom only)
      • On completion, you'll be awarded an internationally recognized BSI Training Academy certificate

    • Download course guide >

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