A quality management (QM) program is an integral part of a continually improving organization. The CDRH Quality Management Program provides tools and resources to help improve the consistency of our operations, make sound choices concerning quality, measure our progress in meeting quality objectives, identify what is working or what is not working and assist in bringing identified issues to a satisfactory resolution.
The CDRH Quality Framework
The CDRH Quality Management Framework is intended to facilitate the establishment of the CDRH Quality Management Program as it outlines quality principles and practices that apply to our work. While many at CDRH already use some of these principles and practices, the Quality Framework shows how these principles and practices work together, providing a clear quality roadmap for CDRH.
The principles and practices described in CDRH’s Quality Framework address our quality policy and objectives, management review, competencies and training, process document control, feedback, evaluation, corrective action and preventive action, process improvement, measurement, and data analysis.
CDRH intends to apply the framework and develop the program over time. Full implementation will require on-going effort and is resource dependent.