ISO 13485:2016 Clause by Clause
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.
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
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What will I learn?
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
- 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
You will gain:
- Training course notes