• 17 June, 2020
• Posted by: K2A Management Co., Ltd-EIA Consulting

ISO 13485 Foundation Course 

A highly interactive 1 day ISO 13485 foundation training course that is designed to give delegates a sound knowledge of the requirements of ISO 13485 and the fundamentals of a medical device management system

Duration - 1 Day

Course Objective

By the end of this ISO 13485 training course, delegates will be able to:

• Interpret the basic requirements of ISO 13485 as it relates to quality management systems.
• Apply the process approach to managing a company’s quality system, its control and effectiveness.
• Compare ISO 13485 with ISO9001 and the FDA’s QSR requirements with the view of implementing the Standard.
• Identify the importance of Design Control, Corrective and Preventative Action (CAPA) and Production and Process Control (P&PC) and how these can add value to processes.
• Practical workshops are designed to reinforce the discussions and topics. This style of delivery makes the course both memorable and enjoyable for participants, ensuring long-term learning.

Course Content:

• Introduction and overview of the requirements of ISO 13485
• Comparison of the requirements of ISO13485 with FDA’S QSR and ISO9001 requirements.
• Introduction to the Guide ISO/TR14969
• Risk management requirements and ISO 14791
• The implications of ISO 13485 for the Medical Device Industry in maintaining registration and market approval.
• Analysis of a process-based management system and the impact this may have on a company’s procedural based system.
• The approach of Regulators.
• Sources of information and further development

Contact us: trainings@k2mnagement.com

www.iso-certifications.com