Quality Management System Implementation Training Program based on ISO 13485:2016 Standard

Course Overview

The success of an organisation, the penetration of its products and services in the market, efficient internal procedures, and a healthy economic status depends essentially on how MD-QMS requirements and requirements for regulatory purposes are consistently ensured, maintained, and improved. ISO 13485 – Medical Device – Quality Management Systems –Requirements for regulatory purpose – address the development, implementation and maintenance of quality management system intended for use by medical device manufacturers and suppliers. The standard details the requirement for quality management systems, to meet customer requirement and allows the incorporation of applicable regulatory requirements within an organization’s quality management system. 

Course objectives

• Understanding the quality management system requirements for medical device industries
• Implementation of ISO 13485:2016 based Quality management system
• Understand how you can better meet regulatory requirements leading to increased patient safety
• Develop safe and effective medical devices

Course content/outline

Day – 1

• Quality concepts
• Overview of quality management system
• Benefits and purpose of quality management system
• Key definitions
• ISO 13485:2016 standard requirements
  

Day – 2

• Implementation of Process approach
• Setting quality policy and objectives
• Implementing risk based approach
• Overview of risk management
• Identification of requirements of documentation and records

Note:
Classroom exercises will be spread over both the days

Training duration

2 Days

Prerequisites

Preferred to have basic knowledge of Quality Management System and / or experience in medical device operations.

CERTIFICATION

At the end of the course, participants will receive an attendance certificate from TÜV SÜD South Asia.