Terumo Cardiovascular Group

About Terumo CVS' Consent Decree

The Role Of A Quality System

A Quality System is an integrated set of structures, processes and procedures created by a medical device manufacturer to control all aspects of its operations with the intent of ensuring:

  • The products it distributes meet all intended specifications
  • Every process produces a predictable result, without variation
  • The manufacturing process is compliant with Quality System Regulation and current Good Manufacturing Processes
Quality System

Kimberly A. Trautman, FDA, Quality System Regulation,
21 CFR 820, Basic Introduction

The simplified illustration of a Quality System (at top) shows the interrelationships between some of the key “subsystems” with a Quality System. In reality, the Quality System Regulation defines fourteen such sub-systems, or “subparts” as they are referred to in the Regulation. A manufacturer creates processes and procedures to ensure predictable results for every task within each and that all subsystems are properly integrated.

The scope and scale of a manufacturer’s Quality System must be commensurate with the complexity of the devices, the size and complexity of the organization, and the risks presented by the devices. It is worth noting that heart-lung machines and related products are considered life-sustaining devices and, as such, are subject to the most stringent assessments of risk and require the most robust Quality System.