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USP Announces ISO Registration for Quality Business Process

April 14, 2004 --Rockville, Md. - The United States Pharmacopeia (USP) is pleased to announce it has successfully completed registration to the prestigious International Organization for Standardization (ISO) 9001:2000 standard for Quality Management Systems.

Certification to ISO 9001:2000 requires companies to implement a quality management system that accounts for a range of activities including staff training, customer requirements, product design and development, and delivering products and services. Meeting the standard's rigorous demands demonstrates that USP's quality management system provides effective and efficient management of internal processes to ensure USP's products and services meet international quality requirements.

"One of the objectives of USP is for our products and services to be recognized globally for their quality attributes," said P. Steven Lane, director of quality assurance. "ISO registration provides external validation that our internal processes meet world-class standards for quality management practices."

Following an extensive internal review of business and quality management practices, USP partnered with the BSI Management Systems, a globally recognized leader in management system certification, to become officially registered to the ISO 9001:2000 Quality Management Systems standard. USP's overall business operations and infrastructure comply with all customer quality requirements and regulations for its products and services.

"ISO registration is an important achievement for USP," said Roger L. Williams, M.D., executive vice president and chief executive officer of USP. "This achievement will benefit our customers and other stakeholders in many ways and will certainly help us prepare for the next phase of ISO registration."

USP has also committed to registration to ISO 17025, which will demonstrate compliance in the science laboratories. Completion of this registration is expected by the end of 2004.

ISO, the world's largest developer of quality and environmental standards for business, government, and society, is an international network for the national standards institutes of 148 countries coordinated by the Central Secretariat in Geneva, Switzerland.
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USP-Advancing Public Health Since 1820
The United States Pharmacopeia (USP) is a nonprofit, nongovernmental, standard-setting organization that advances public health by ensuring the quality and consistency of medicines, promoting the safe and proper use of medications, and verifying ingredients in dietary supplements. These standards, which are recognized worldwide, are developed by a unique process of public involvement through the contributions of volunteers representing pharmacy, medicine, and other health care professions, as well as science, academia, government, the pharmaceutical industry, and consumer organizations. For more information about USP and its four public health programs, visit

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