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USP achieves continued ISO 9001:2008 certification

The U.S. Pharmacopeial Convention (USP) headquarters has been recommended for continued certification of its quality management system in accordance with ISO 9001:2008 based on a successful surveillance audit by the BSI Group in August.

The ISO 9001:2008 certification demonstrates that USP's quality management system is evident under the standard and provides effective management of internal processes to meet international quality requirements. This certification reflects USP's continued commitment to the highest standards of quality. USP first achieved ISO 9001 certification in 2004 for its quality management system. It also first achieved ISO 17025 accreditation in 2004 for competence in laboratory testing and calibration. All of USP's global sites are audited against ISO standards.

USP's ISO 9001:2008 accrediting body is the independent registrar, the BSI Group. Additionally, USP's ISO 17025:2005 accrediting body is ACLASS, one of three ANSI-ASQ National Accreditation Boards.

USP is a nonprofit, scientific organization that develops public standards to help ensure the identity, strength, quality and purity of pharmaceuticals, food ingredients and dietary supplements in the United States and worldwide.

“As an organization that sets quality standards for use around the world, we feel it is imperative that we, too, adhere to the highest quality of standards in all the work that we do,” said Roger L. Williams, M.D., USP's chief executive officer. “I commend the staff for their diligence in helping to ensure USP's internal processes are up to par with this rigorous international standard.”

To achieve this accreditation, auditors looked at USP's information technology security plan, the implementation of tools for improved reporting in finance/accounting, organizational operation manuals, among others. USP headquarters passed the ISO 9001:2008 continued accreditation with zero non-conformities and zero opportunities for improvement, which are the best results that can be achieved from the surveillance audit.
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