ISO 13485:2016 Internal Auditor Training

Description

Understand the requirements of ISO 9001:2008 and ISO 13485:2016 to be able to conduct a successful audit. The course includes hands-on workshops to prepare you for real-life auditing situations. You’ll learn to manage the audit process and complete reporting.

This is a three-day, instructor-led classroom course. There are written tests on each of the competency units on days 2 and 3. Days 1 and 2 will cover medical device auditing along with a corresponding competency exam. Day 3 will cover management systems auditing (AU) along with a corresponding competency exam.

Objectives

• Fully understand and successfully interpret the ISO 13485 requirements
• Understand how to audit using the process approach
• Ask audit questions that get results