ISO 13485:2016 Overview

Provided by: MEP Courses

This workshop will provide you with a concise but detailed review of the new ISO 13485 Medical Devices Quality Management System standard. We will compare the 2016 version to the 2003 version, and explain the new requirements of the 2016 standard. We will also talk about transitioning from to the 2016 standard, including timing requirements. Activities include developing a ìList of Interested Partiesî for your QMS. There will also be time for questions and answers.


Course Objectives:

  • Describe the history and purpose of ISO 13485


Recommended Background

  • Management representatives, quality professionals, personnel functioning as internal auditors

Course ID

99999958

Location

Company Choice

Instructor(s)

Purdue University MEP

Competencies

Communication, Critical Thinking, Personal Effectiveness, Functional Auditing

Method of Delivery

Face to Face

Estimated Effort

4 hours

Cost

Negotiable