ISO 13485:2016 Internal Auditor Training

3 Days - 2.4 CTUs - $1395 - Competency Units MD & AU

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

Have questions? Contact us

DEKRA Audits

8990 Springbrook Dr. NW

Suite 210

Minneapolis , MN 55443

+1 800.633.2588
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