ISO 13485 Introduction

ISO 13485 Introduction


ISO 13485 Introduction is designed to develop an understanding of the various requirements of the ISO 13485 standard as a basis for the implementation of a company-wide Quality Management System (QMS). This course is designed for top management, Quality and/or regulatory management and other key people who may be involved in implementing a QMS based on ISO 13485.

Participants will obtain a clear picture of:

  • The Requirement of ISO 13485
  • Understanding the importance of meeting legal requirements
  • Developing, implementing, maintaining and ensuring the effectiveness of your QMS 
  • The role of leadership in sustaining the QMS including key elements of the management system 
  • The underlying requirements for effect process controls
  • The third-party certification process 

Upcoming Classes


December 09, 2021
8:00 AM- 5:00 PM
45501 Helm St.
Plymouth, MI

Team Building is an activity-based training that will provide participants an understanding of the importance of teamwork.
Southeast Michigan