ISO 13485:2016 Medical Device Quality Management Systems (MD QMS) Internal Auditor Training Course
This course will provide learners with the knowledge and skills required to perform an internal audit, based on the Medical Devices Quality Management System (MD QMS) requirements of ISO 13485:2016.
Course Overview
What you'll learn
Upon completion of this course, learners will be able to:
- 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
This course is designed for:
- Medical professionals who have a knowledge/experience of performing ISO 13485:2016 audits.
- Medical Device Quality Management Auditors.
NOTE: Learners are required to obtain a copy of the ISO 13485:2016 Medical Device Quality Management Systems Standard. Learners should familiarise themselves with the standard prior to attending the training course.
Virtual Course requirements:
To ensure your access to the virtual course and to gain the most out of this training we request all learners have:
- Reliable internet access (High speed)
- Computer with microphone and camera capabilities
Assessment and group activities for this course requires your camera to be turned on. Background effects such as blurring can be used for preserving privacy.
About this course
This course will provide learners with the knowledge and skills required to perform an internal audit, based on the Medical Devices Quality Management System (MD QMS) requirements of ISO 13485:2016.
The course covers the following content:
- Introduction to Medical Device QMS and ISO 13485:2016; Clause 4 (Quality Management System), Clause 5 (Management Responsibility), Clause 6 (Resource Management), Clause 7 (Product Realisation) and Clause 8 (Measurement Analysis and Improvement)
- Audit: Definition, Principles and Types
- Roles and Responsibilities of Auditors
- Planning and Preparation for the Audit, including On-site Activities
- Audit Reporting and Follow-up
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