The objective of this course is to provide delegates with the skills required to conduct internal audits as required by ISO 13485.
Upon completion of this course delegates will be able to :
- Understand the requirements of ISO 13485:2016, and the quality system requirements of Directives 93/42/EEC and 98/79/EC
- Know how to conduct internal quality system audits :
- understand the role of internal audit in the maintenance and improvement of management systems
- plan and prepare for an internal audit
- learn to gather evidence by observation, questioning & sampling
- write factual reports on the compliance of the management system against the audit standards
- participate in the corrective action process