ISO 13485:2016 Foundation Course

This 1-day course clarifies ISO 13485:2016 requirements and interpretations. Organizations that need to show evidence that they can provide medical devices which consistently meet customer and regulatory requirements will benefit from understanding ISO 13485. Whether you are an ISO 13485 novice or an old pro looking to refresh your skills, this course is a must.

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