ISO 13485:2016 Internal Auditor Training
3 Days - 2.4 CTUs - $1395 - Competency Units MD & AU
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 requirements with a corresponding competency exam. Day 3 will cover management systems auditing (AU) along with a corresponding competency exam.
Who Should Attend
Those responsible for planning and scheduling an audit program for ISO 13485 and those who must perform audits to ISO 13485, Quality Assurance Managers, Quality Assurance Professionals, ISO Project Managers, ISO Project Team Members, Compliance Managers, Regulatory Personnel or anyone desiring an in-depth understanding of the ISO 13485 Audit Process. This course has been specifically designed to meet the needs of the Medical Device Industry.