This 3-Day course is designed primarily to provide participants with a detailed understanding of the changes and the effects of the new ISO 13485:2016 standard including risk management. In addition, upon successful completion of the course, participants will:
- Be able to effectively plan, prepare and carry out an internal audit as per ISO 13485:2016
- Be able to evaluate the significance of audit findings, develop and implement corrective action programs
- Have the means to effect greater improvements on their quality systems
Course Content
- Introduction to ISO 13485:2016
- ISO 13485:2016 Overview
- 1) Section 4: Quality Management System
- 2) Section 5: Management Responsibilities
- 3) Section 6: Resources Management
- 4) Section 7: Product Realization
- 5) Section 8: Measurement, Analysis and Improvement
- Auditing ISO 13485:2016
- Audit Performances and Audit Reporting
- Corrective Action