A comprehensive Quality System is the core foundation for setting the structure, procedures, processes and resources of an organization for controlling the quality of products and for maintaining continuous quality improvement.

Traditionally, pharmaceutical and medical device manufacturing industries have implemented Quality Systems to comply with the U.S. Food and Drug Administration (FDA) regulations. These statutes provide the necessary framework for implementing a system that meets FDA's expectations but do not suffice for international practices.

This project proposes the development of a comprehensive, compliant, and harmonized Quality System for implementation in pharmaceutical - medical device manufacturing organizations. The system is built using the new FDA's Quality Systems approach and it is evaluated against International Organization for Standardization (ISO) and International Conference on Harmonization (ICH) Quality Systems Standards for possible enhancements and to determine global compliance. This paper discusses why a quality system is needed and how organizations may benefit from it.