CFSAN Laboratory Quality Manual Third Edition
The use of a quality systems approach is increasing within the Food and Drug Administration (FDA). To help enhance consistency, efficiency and effectiveness of day-to-day work, the FDA has adopted a quality system model and established an FDA-level committee to help employ this quality system initiative.
The Center for Food Safety and Applied Nutrition (CFSAN) Quality System (QS) provides guidance to:
(1) design and develop processes, products, and services related to CFSAN’s mission, the FDA’s regulatory mission, and to critical management and administrative support services, and (2) continually improve and strengthen product and service quality. This Laboratory Quality Manual contains the required information to implement quality principles and practices throughout CFSAN’s laboratories. This manual serves as a key element in the implementation of a Quality Management System (QMS). The anticipated audience for this manual includes those in the public, regulated industry, counterpart agencies, CFSAN scientists and other FDA staff members who wish to understand CFSAN QMS.
Training is an essential element of QS implementation. For CFSAN, training is necessary prior to achieving accountability for the policies and procedures described in this manual. For others, general information about quality systems may be found on the Internet at:
American Society for Quality, “Learn About Quality” (www.asq.org)
