Course description
This two-days 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.
Upcoming start dates
Suitability - Who should attend?
- 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
Outcome / Qualification etc.
- 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
- Comprehensive training notes and 14 CPD points on completion
Training Course Content
- 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
Course delivery details
- 14 CPD points on completing the course
- Training course notes
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BSI, the British Standards Institution, is one of the world’s leading providers of training, certification, standards, regulatory approval, business improvement and management development for local and global audiences.
Our expert teams provide top quality training to organizations of all sizes and every type of industry - ranging from leading multinationals to small, innovative start-ups and from governments to charities. From understanding how a standard can help your business,...