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  5. CDRH Quality Management Program
  1. Center for Devices and Radiological Health

CDRH Quality Management Program

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.

CDRH Quality Policy

CDRH is committed to delivering high-quality products and services to its customers in pursuit of achieving its Mission and Vision. It is the responsibility of every CDRH manager, supervisor, and employee to pursue quality in the performance of our jobs. To do so, everyone at CDRH must understand what quality means to the Center and how the choices we make affect quality.

CDRH is committed to implementing and continually improving the Quality Management System (QMS), fully meeting the requirements of ISO 9001, Quality Management Systems Requirements standard. The QMS is the vehicle to fulfill our [top management’s] commitment to continually improve the quality of our products and services. It provides processes to improve the consistency of our operations, help us make sound choices concerning quality, measure our progress in meeting quality objectives, identify best practices and opportunities for improvement, and bring identified issues to a satisfactory resolution. We monitor and review our performance relative to quality objectives and make timely adjustments as required to better fulfill the needs and expectations of our customers and stakeholders as we pursue organizational excellence.

CDRH Quality Objectives

CDRH’s quality objectives align with our quality policy and the strategic direction of CDRH and will evolve over time as the QMS matures and the Center achieves its goal to establish a culture of quality and operational excellence. The quality objectives focus on effectiveness of the Quality Management System (QMS) and developing baseline measures of quality:

  • Meet the needs and expectations of our customers and achieve and maintain customer satisfaction;
  • Maintain an effective program through a focus on risk management and continual improvement;
  • Achieve and sustain a culture of quality and operational excellence.

For questions or additional information about the CDRH QM program, please email CDRH-QM@fda.hhs.gov.

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