chapter  23
22 Pages

Quality System Regulations Requirements and Compliance

Each manufacturer must establish and maintain a quality system that is appropriate for the specific medical devices designed or manufactured.

The regulations make it clear that it is the responsibility of executive management to establish a quality system and to ensure that it is both implemented and understood at all levels of the organization. A member of management must be appointed whose assigned role is to ensure that the quality system requirements are effectively established and maintained, and to report to management on the system. The use of the term establish indicates that the requirements must be documented, either in writing or electronically, and then implemented.