Quality Management System

Quality Management System

Pam Fox, Quality Manager

Advantages of Certifying as ISO 13485 Quality Management System

A Quality Management System (QMS) that is certified to the ISO 13485 international standard represents a standard that ensures consistency, efficiency and effectiveness.  Though based on ISO 9001, 13485 represents the requirements that medical device manufacturers must incorporate into their quality management systems.  13485 certification aligns a company’s QMS to the requirements of the FDA’s Quality System Regulation (QSR) requirements as well as other international regulatory requirements. QMS ensures products are manufactured in a consistent manner and the ISO 13485 certification serves to create a management system that can be thought of as a framework on which to build compliance to various regulatory and customer requirements.