Classroom 2 days
43240443
ISO 13485:2016 Medical Devices Awareness/Introduction
Description
This 1-Day course is designed primarily to provide participants with a detailed understanding of the changes and the effects of the ISO 13485:2016.
The key topics include:
- 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
Objectives
Upon successful completion of the course, participants will:
- To enable participants to understand the requirements of ISO 13485:2016
- Provide an overview of the new requirements / changes from the ISO 2003/ENISO2012 version to the 2016 version of ISO 13485
Audience
- Managers, Executives, Supervisors and those who are involved in ISO 13485:2016
- 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.
Classroom 2 days
43240443