ISO 13485:2016 Clause by Clause

Level Requirements Duration 2 days

Available to book: Virtual classroom $2195 View dates and book now

This two-day course provides an in-depth understanding of ISO 13485:2016. It’s designed specifically for those who are looking to further their knowledge of the management system.

Training will be delivered either live and online or in-person in a classroom setting. You will learn how to explain the scope and structure of ISO 13485:2016 and interpret what’s required for your own organization. You will finish this stage of your learning journey with deeper knowledge and confidence and have a clear pathway for putting ISO 13485:2016 certification into place for any organization.

How will I benefit?

Full understanding of ISO 13485:2016 requirements
Able to explain and interpret requirements, relevant to your organization
Learn how a quality management system provides a framework for safer medical devices

- Explain the scope and the structure of the ISO 13485:2016
- Describe the requirements of ISO 13485:2016
- Explain how to understand and interpret and apply the requirements of the standard within an organization
- Develop an understanding of how the requirements of ISO 13485:2016 are established in an organization and maintained
- Consider the systems that are required to implement an ISO 13485:2016 quality management system
- Discuss how to ensure that the requirements of the system are effectively implemented to allow the organizations quality system to be certified and/or maintaining certification
- 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 more in depth knowledge
- Delegates attending the Lead Auditor to ISO 13485:2016 course
On completion of the ISO 13485 Clause by Clause course participants will have the option to complete an online multiple choice exam. If you choose not to sit the exam, a certificate of attendance will be issue for the course.
- A loan copy of the standard for use during the course
- Gain 16 CPD points on completion and comprehensive training notes
- Gain an internationally recognized BSI Training Academy certificate

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