2-Day ISO 13485 Internal Auditor

Days: 2 • CEU Hrs: 1.9

 7:30 a.m.- 5:30 p.m.

Audience: Beginner to Advanced

Overview 

This course prepares you to perform effective audits of Medical Device Quality Management Systems.  You’ll learn how to interpret the verbiage of the 13485 Standard and apply it to your own organization.  We also cover the requirements of 21 CFR 820, the federal regulations governing medical device management systems.  We’ll take you through the full audit process, including: audit planning and preparation, opening meetings, document review, interviewing auditees, closing meetings and reporting.  Training includes easy-to-use tools to simplify the auditing process.

This is a practical, how-to course that is not bogged down in academic discussions.  We use case studies, role-plays, and other real-life practice exercises to keep the training active and build competence.

Who Should Attend?

Prerequisites

None.  Our students range from seasoned quality professional to novices.  Our goal is to meet everyone at their current level of competence and increase it.  All students are required to bring their own printed copy of ISO 13485:2016.  Most students will be able to obtain a copy from their company.

Course Objectives

• Help you develop the knowledge and skills required to become a Lead Auditor.
• Improve your understanding of the International Standard and 21 CFR 820
• Learn how to audit to the requirements of the Standard and to your own Standard Operating Procedures (SOPs)