21 CFR 820 - 820.5 Quality System
Original text
Expert opinion
Each manufacturer shall establish and maintain a quality system that is appropriate for the specific medical device(s) designed or manufactured, and that meets the requirements of this part.
The 21 CFR 820 is both regulation and quality management system. Thus, the industry is calling it Quality System Regulation (QSR).
To establish is understood within the QSR as to have written procedures established and implemented. The quality system must be maintained in order that it fulfills the requirements in the QSR.
