Duration
3 Hours
Course access time
Course access time is limited to 30 calendar days starting from the day a user has been given access to the learning material.
Cost
$299.00 USD
Certificate
The attendee will receive our Certificate of Participation after completing the entire course.
Objective
This ISO 13485:2016 Awareness Course provides managers and employees with the knowledge required to effectively manage a medical device quality management system. During this course, you will learn the ISO 13485:2016 Standard requirements and the best practices for a medical device quality management in 7 modules. As managers/employees in an organization, the more you know about ISO 13485:2016 Standard and the medical device quality management system, the better prepared you are to meet customer and applicable regulatory requirements for your products and services.
Course Content
Module 1: Background and Introduction of ISO 13485:2016 Standard and Common Terminology
Module 2: Introduction of ISO 13485:2016 Requirements related to Clause 1 to 3 - Scope, Normative References, Terms and Definitions
Module 3: Introduction of ISO 13485:2016 Requirements related to Clause 4 - Quality Management system
Module 4: Introduction of ISO 13485:2016 Requirements related to Clause 5 - Management responsibility
Module 5: Introduction of ISO 13485:2016 Requirements related to Clause 6 - Resource Management
Module 6: Introduction of ISO 13485:2016 Requirements related to Clause 7 - Product realization
Module 7: Introduction of ISO 13485:2016 Requirements related to Clause 8 - Measurement, Analysis & Improvement
Mandatory Documents Required for ISO 13485:2016
Course Summary
Annex A (informative) Comparison of content between ISO 13485:2003 and ISO 13485:2016
Annex B (informative) Correspondence between ISO 13485:2016 and ISO 9001:2015
Conclusion
Who should attend?
- Personnel in an organization new to ISO 13485:2016 Standard
Pre-requisites:
None
Learning Outcomes
Upon completing this course, you will be able to:
- Understand the ISO 13485:2016 standard requirements and how to apply the requirements to your company
- Learn the best practices for medical device quality management
- Demonstrate continual improvement of your medical device quality management system