Executive Introduction Review of Requirements - ISO 13485

Continual Improvement

Management Systems

Course Description

The introduction examines the key elements of ISO 13485, including the structure of the standard, the main management requirements, and plan to start implementation. Participants will understand the key sections of ISO 13485 and have the opportunity to discuss the application and implementation of the standard.

Course Objectives

Background on ISO 13485 as a Quality Management System (QMS)
The key ISO 13485 Medical Device QMS requirements

• A commonsense approach to address the requirements
• How to integrate these requirements into a company’s existing processes

Getting your Quality System started

• When to get started
• How to get started
• Who should be involved

Course Outline

Who Should Attend:

• Executives who need to make decisions about ISO 13485 in their business
• Managers who need a comprehensive understanding of quality system standards and how to implement the standards in their facility