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At TÜV SÜD Academy, we agree with Dr. Eamonn Hoxey, Chair of ISO technical committee ISO/TC 210, Quality management and corresponding general aspects for medical devices, the patient comes first.
ISO 13485:2016 is the management system that governs medical devices, the management system upon which compliance with regulatory and customer compliance can be built. It embodies an agreed upon, repeatable way of managing production, validation, quality, and risk management.
At the heart of ISO 13485:2016 is a comprehensive risk management process meant to be implemented in all medical device-related quality management processes within an organization, including processes that occur after the medical devices are placed on the market.
This two-day course, conducted by our experienced TÜV SÜD Academy instructors, will introduce students to the requirements of ISO 13485:2016 and will explain in detail how to integrate the requirements into quality management systems. Students will be equipped with the knowledge and skills needed to plan and conduct effective internal audits.
This online course is designed to illustrate how organizations can benefit from becoming skilled in integrating this standard into their processes. By learning how to audit your processes, you signal to your customers that you take quality and customer needs seriously.
This course is intended to help you to understand ISO 13485:2016 and to conduct internal audits. Through examples, exercises, and a final exam, you will be familiar how this standard applies to the life-cycle of a medical device. The course covers the entire standard ISO13485:2016, and participants will learn about audit techniques, including behavior as well as questions and approaches for different clauses and requirements. Explanations of the necessary audit tasks and appropriate treatment of the nonconformities are an integral part of the training.
This course is designed for every employee who can perform internal audits under the scope of ISO 13485:2016, including medical device manufacturers and vendor personnel who will be involved in the launch of management systems or updating of the current management system, quality management officers (QMOs), product managers, and consultants in the medical device industry.
ISO 13485:2016 Management System Implementation
Auditing Concepts and Principles
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Bosnia and Herzegovina