Internal Auditor for ISO 13485

The aims and learning outcomes of this course are:

• To understand the principles of auditing for Medical Devices and IVDs.
• To effectively plan and schedule an audit.

Following completion of this course, participants should:

• Understand the auditing requirements of ISO 13485.
• To be able to run an audit of a manufacturer, supplier or distributor of Medical Devices and IVDs.
• Be able to actively participate in writing an internal audit schedule and preparing a business to be audited.

This course is held live in an online lecture theatre and delivered with a PowerPoint presentation. All participants will fully engage with the lecturer through both group and individual exercises and direct participation throughout the course. There are exercises included in order to ensure the course contents are fully understood and the opportunity is always available for participants to ask questions.

This five module course works through auditing requirements and is broken down into 5 modules.

1. Introduction to ISO 13485.
2. Principles of auditing.
3. Planning an audit.
4. Audit techniques.
5. Reports and follow-up.