The purpose of this course is to equip learners with an understanding of the concept of Medical Device Quality Management Systems (MD QMS) and provides an overview of the purpose and requirements of ISO 13485:2016 as a tool for business improvement.
Description
The purpose of this course is to equip learners with an understanding of the concept of Medical Device Quality Management Systems (MD QMS) and provides an overview of the purpose and requirements of ISO 13485:2016 as a tool for business improvement.The course covers the following content:
- Introduction and Structure of ISO 13485:2016, Clauses 1 to 3
- Clauses 4 (Quality Management System) and 5 (Management Responsibility)
- Clauses 6 (Resource Management) and 7 (Product Realisation)
- Clause 8 (Measurement Analysis and Improvement)
Objectives
Upon completion of this course, learners will be able to:- Understand and interpret the structure and requirements of clauses 1 to 8 of ISO 13485:2016
- Understand and explain the purpose and benefit of a Management Development Quality Management System (MD QMS)
- Use the terminology of ISO 13485:2016
On completion of this course learners will be issued with a "Certificate of Attendance"
Audience
This course is designed for:- Professionals looking to understand the concept of ISO 13485:2016 MD QMS as a tool for business improvement
- Medical Device Quality Management representatives
Virtual Course requirements:
To ensure your access to the virtual course and to gain the most out of this training we request all learners have:
- Reliable internet access (High speed)
- Computer with microphone and camera capabilities
Virtual Class (1 Class) 1 Day
81543613English