Every employee in your ‘Medical Device’ company has an important role to play in your Quality Management System (QMS)s.

You are participating in this training to learn the basics of a QMS and what it means to be ISO 13485 registered and how it will affect your job as a manufacturer of medical devices.

Today we will cover the following topics so that you will better understand your company’s Quality Management System. I will begin by providing some basic information regarding management systems and ISO standards.

I will then explain:

• What is a QMS and What is ISO 13485
• Why it is important to your company to achieve ISO 13485 registration
• What are the benefits of achieving registration
• What are the elements necessary to establish and manage and ISO 13485 QMS, and
• How can you support your organization's QMS.
• For the rest of the training, we will use the term QMS which means the Quality Management System