ISO 13485 Medical Devices Quality MS – Introduction

1. Brief Description:

The ISO 13485 Medical Devices Quality Management System (QMS) Introduction scheme is designed to provide learners with an understanding of the basic principles and requirements of a QMS based on the ISO 13485 standard. This scheme is an entry-level course that is suitable for individuals who are interested in learning about quality management in the medical devices industry.

2. Key Topics:

The key topics covered in the ISO 13485 QMS Introduction scheme include:

• Introduction to quality management in the medical devices industry
• Understanding the principles and concepts of quality management
• Requirements of ISO 13485 standard for a QMS
• Implementation of a QMS based on ISO 13485 standard
• Continual improvement of a QMS

3. Audience:

The ISO 13485 QMS Introduction scheme is intended for:

• Individuals who want to gain a basic understanding of quality management in the medical devices industry and ISO 13485 standard
• Individuals involved in the implementation of a QMS for medical devices
• Managers and employees responsible for ensuring the quality of their organization’s medical devices

4. Learning Objectives:

By the end of the ISO 13485 QMS Introduction course, learners will be able to:

• Understand the basic concepts and principles of quality management in the medical devices industry
• Explain the purpose and requirements of ISO 13485 standard for a QMS
• Identify the key components of a QMS and how they can be implemented
• Describe the benefits of implementing a QMS based on ISO 13485 standard
• Understand the importance of continual improvement of a QMS for medical devices.