ISO 13485:2016 Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes Awareness Course

1. INTRODUCTION
   ISO 13485 is the medical device industry’s most widely used international standard for quality management.  ISO 13485 forms the foundation for defining a system of processes for an organization to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.

2. COURSE OBJECTIVES
   The objectives of this training aim to provide to the participants an interpretation of the ISO 13485:2016 requirements as well as an understanding of the rationale and the foundation of the standard.

3. COURSE CONTENTS
   • Introduction of the ISO 13485:2016 transition process;
   • Approach and concept in ISO 13485:2016;
   • The ISO 13485:2016 requirements;
   • Quality management system; management responsibility; resource management; product realization; measurement, analysis and improvement;
   • Risk management approach to product development and product realisation;
   • Course summary

4. WHO SHOULD ATTEND
   This course is compulsory and designed for quality professionals, management staff, QA and QC Engineers and supervisors who are likely to involve or currently involving in the implementing of the ISO 13485:2016 Quality Management System.

5. ADMINISTRATIVE DETAILS
   

   Time	: To be advised
   Duration	: To be advised