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
This training course is HRDF approved under the SBL scheme.
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
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
- Training course notes
- Loan copy of the standard (to be returned after the course)