Single Course
Medical Devices
ISO 13485:2016 Medical Devices Quality Management System Internal Auditor Training
Virtual Class
English
Identifier: 51099780
Course Overview
What you'll learn
- Explain the purpose of a Medical Device Quality Management System (MD QMS) and the business benefits of improving MS performance.
- Understand the basic requirements of ISO 13485:2016.
- Explain the audit definitions, principles of auditing and types of audits.
- Explain the role and responsibilities of an Auditor to plan, conduct, report and follow-up an internal MD QMS, in accordance with ISO 13485:2016.
- Prepare documentation and understand how to establish conformity (or otherwise) against ISO 13485:2016 and local regulations, as applicable.
Who This Course Is For
The ISO 13485 Internal Auditor Course includes the in-depth interpretation of ISO 13485 requirements, auditing skills and case studies to ensure thorough implementation of ISO 13485 and audit skills within the organization.
About this course
The training has been designed to give you the necessary skills to perform internal audits on an organisation’s Quality Management Systems (QMS) for Medical Devices to the requirements of ISO 13485:2016 and to contribute to their continual improvement .
The training comprises presentations, workshops and interactive role-play exercises with medical device lead auditors experienced in ISO 13485 and Notified Body audits.
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