The Internal Auditor training course aims to develop the necessary expertise that you need to perform a Medical Devices Quality Management System internal audit by applying widely recognized audit principles, procedures, and techniques. During this training course, you will acquire the necessary knowledge and skills to plan and carry out internal audits in compliance with ISO 19011.
We will use practical exercises that will assist you to master audit techniques and become competent to manage an audit program and communicate with auditees.
This course does not detail the requirements of ISO 13485:2016 so some previous knowledge is required.
Who should attend?
Managers or consultants seeking to master a Medical Devices QMS audit process
Individuals responsible for maintaining conformance with Medical Devices QMS requirements
Individuals interested in conducting first-party or second party audits
Technical experts seeking to prepare for a Medical Devices QMS audit
What will you learn?
Structure and Scope of ISO 13485 in relation to regulatory compliance
Fundamental audit concepts and principles
The responsibilities of an auditor
Plan an internal audit that is based on evidence and risk
Understand the auditing process and the process approach to auditing
Check for the effective implementation of corrective action
How will you benefit?
This course will help you:
Understand an auditor’s role to plan and conduct an audit
Draft evidence-based audit reports
Interpret the requirements of ISO 13485:2016 in the context of a Medical Device QMS audit
What is included?
Training course materials containing practical examples
Lunch and Refreshments (for face to face training)