Online ISO 13485:2016 Foundation Training (CQI & IRCA Pending)
This fully online course is ideal for anyone that wants to gain a comprehensive understanding of the requirements of ISO 13485:2016 and wants to flexibility to learn at their own pace and in their own time.
If you are interested in this course, we recommend having a look at our free online ISO 13485:2016 introduction course. Check it out today!
- 7 Hours
Module 0 - Course Introduction
In this module, an introduction to the course will be provided. This includes important information regarding the course content & learning objectives, duration, assessment methodology & how to successfully complete the course.
Module 1 - Introduction to ISO 13485:2016
In this module we will explore the purpose, scope, benefits, structure and key terminology of ISO 13485:2016. We will also explore the process approach and the relationship between ISO 13485:2016 and relevant statutory/regulatory requirements.
Module 2 - Quality Management System
In this module we will cover the requirements related to establishing the QMS including establishment of the QMS processes, change control and QMS documentation requirements including control of documentation and records.
Module 3 - Management Responsibility
In this module we will explore the role of Top Management in relation to the QMS including coverage of the quality policy, quality objectives, responsibilities, authority and communication, and the management review.
Module 4 - Resource Management
In this module we will explore the resources (human, infrastructure, work environment and contamination control) that are required to implement and maintain the QMS.
Module 5 - Product Realization, Part 1
In this module we will explore the requirements related to pre-production and service provision, namely: customer related processes, design and development and purchasing.
Module 6 - Product Realization, Part 2
In this module we will explore the requirements related to production and service provision and control of monitoring and measuring equipment.
Module 7 - Measurement, Analysis and Improvement
In this module we will explore the requirement related to monitoring and measurement including feedback and complaint handling. We will also cover reporting, the internal audit and control of nonconforming products.
This course is fully certified by Comply Guru™. An application is being made to CQI & IRCA for certification of this course.
In order to successfully complete the course, each Learner will need to obtain a grade of 70% or higher in the final examination. Successful completion will entitle each Learner to receive a certificate of completion.