ISO 9001:2008 Certified Lead Auditor with Medical Device Focus (ISO 13485:2016)
This course will help you:
- Fully understand and interpret the requirements of ISO 9001 in a Medical Device Environment
- Fully understand and interpret the requirements of ISO 13485
- Understand the differences between ISO 9001 and ISO 13485, including the critical differences in requirements for continual improvement and customer satisfaction
- Understand the requirements contained in 21 CFR 820 and be able to compare these to the requirements in ISO 13485
- Conduct a practical audit exercise to 21 CFR 820 to ensure understanding of these requirements
- Understand how to apply the requirements of ISO 9001 and the ISO 13485 Standards during 5 practical audit exercises conducted during the class
- Understand the terminology of the ISO 9001 and ISO 13485 and how these apply in a Medical Device Environment
- Learn how to develop an ISO 9001 / ISO 13485 auditing system based on the ISO 19011 auditing requirements
- Learn how to ask audit questions that get results
- Learn how to conduct opening and closing meetings that have impact
- Learn how to construct effective audit checklists
- Learn how to generate effective corrective actions
Course Details