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