ISO 13485:2016 Medical Devices Lead Auditor (with FDA requirements)

Description

This course aims to provide participants with the knowledge and skills necessary to carry out audits of management systems against ISO 13485:2016, in accordance with ISO 19011.

Objectives

By the end of this course, participants will be able to:

1. Describe the purpose of the a quality management system for the medical devices industry

2. Have a good understanding of the requirements of  ISO 13485:2016

3. Develop a management system that conforms to the ISO 13485:2016 requirements

4. Apply the principles of ISO 14971: 2007 to the risk management

5. Apply principles of ISO 19011 to the auditing process, plan and conduct an audit in accordance to the ISO 19011

6. Conduct opening and closing meetings for an audit, report writing and understand the classification of findings

Audience

Those responsible for planning and scheduling an audit program to ISO 13485 and those who has to perform audits to ISO 13485, or anyone desiring an in-depth understanding of the ISO 13485 requirements and audit process.