
Description
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
Objectives
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
Audience
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Managers, Executives, Supervisors and those who are involved in organizing and conducting ISO 13485:2016 internal audits
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Personnel who are involved in the implementation and maintenance of the quality management system in accordance to ISO 13485:2016 Standard, or those who wish to know more about the standard and its requirements.
