ISO 13485:2016 Deep Dive - Clause by Clause

Online course available

To address the requirements of Medical Device Directives, manufacturers must demonstrate their commitment to the safety and quality of their medical devices. This course enables a clause by clause understanding of ISO 13485:2016, which provides an effective solution to meet the comprehensive requirements of an effective QMS. Learn to apply your knowledge to the development of an ISO 13485:2016 compliant QMS and maintain the on-going certification of your organization.

Who should attend?

Senior management, quality managers, regulatory affairs managers, internal and external auditors, consultants and anyone involved with the implementation of the standard.

Prerequisites:
There are no formal prerequisites, however it will be useful for delegates to read the standard before attending the course.

What will I learn?

On completion, you should gain the knowledge and skills to:

  • 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

How will I benefit?

This course will help you:

  • 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

Our high impact accelerated learning approach increases learning by improving knowledge retention and skill application. This course is activity-based, resulting in a deeper understanding of the material and a greater impact on job performance.

What is included?

This training course is HRDF claimable.

On completion, you will be awarded an internationally recognized BSI Training Academy certificate.

    Discover our ISO 13485 Qualifications 

    This course forms part of our auditor qualification programme. Our ISO 13485 auditor qualifications will give you a BSI Mark of Trust, reassuring your customers and suppliers that your skills have been validated. You can achieve Practitioner or Professional status by successfully completing courses, exams and demonstrating practical application.

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