About ISO 13485:2016 Foundation Course
Course Objectives
This course pack is designed to help you to understand;
• Quality/ medical management system
• Interpreting the requirements of the ISO 13485
• The benefits of implementation
At the end of this course, participants should be able to describe:
• Gain detailed knowledge of the Clauses of ISO 13485:2016
• Understanding of important Terms and Definitions
• The relationship between ISO 13485:2016 and other quality management standards (e.g. ISO 9001:2015)
• The importance of understanding regulatory requirements for the market you serve.
Who can attend this course
This course is highly recommended for anyone involved in auditing, designing, implementing, maintaining and/or improving a medical device quality management system, or who simply want to further their knowledge of the ISO 13485 standard.
Recommended follow-up courses
ISO 9001:2015 QMS Foundation and Internal Auditor, Root Cause Analysis and Problem Solving
Course agenda
Session 1:
Delegate Introduction
Background and introduction ISO 13485:2016+Amd 11
Chapter 4 Quality Management System,
Chapter 5 Management Responsibility and
Chapter 6 Resource Management
Session 2 after lunch:
Chapters 7 Product Realization and
Chapter 8 Measurement, Analysis and Improvement
Session 3:
Test