Overview:
Quality Systems (QS) are sometimes viewed as a necessary evil or belonging only to production and QA personnel. However, effective QS can help a business not only comply, but excel. This course focuses on medical device companies and how to create, implement, and improve QS that match your company. Both FDA QS and ISO QS will be discussed. We will also cover: how different departments are impacted by QS, the biggest pitfalls in establishing and maintaining QS, and how to critically evaluate your QS. There will be group exercises and lots of interaction among participants to provide multiple options. In QS, it is definitely true that one size does not fit all!

By the end of the course, participants will have gained:

Familiarity with QS concepts
Techniques for organizing and managing QS
Best practices for working in QS
Methods for adapting your QS to be most effective
Course Outline:

Introduction to FDA and ISO
Lifecycles of QS
Myths about QS
Organizing principles
Managing principles
Questions to consider
Resources

Who Should Attend:
This course is aimed at medical device personnel with some familiarity with QS. It will be beneficial to those with limited knowledge of QS, but we will NOT be going step by step through all the requirements of a quality system. Recommended for those in customer service, purchasing, manufacturing, engineering, quality assurance, or related disciplines.

Prerequisites:
No prerequisites.