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Commitment to QualityAt USP, our commitment to quality resonates in our quality policy.
Our commitment to not only meet, but exceed our customers' needs is also evident in the growing emphasis USP places on quality activities—those designed to increase the quality of our products and services. All these activities help to ensure USP is the "Standard of Quality". To demonstrate our commitment, we actively pursue compliance and registration to relevant International Standards Organization (ISO) standards. To this end, USP has achieved the following notable milestones:
Because USP sets quality standards for medicines, food ingredients, and dietary supplements that are used in over 130 countries around the world, it is crucial that USP itself complies with objectively applied quality standards for its operations. It is important to recognize that having a sound quality management system in place doesn't guarantee that mistakes won't happen. However, it does mean we expect a certain level of performance, and we strive to improve upon it daily. These activities are external validations of our systems from third-party sources that are experts in those areas. In this effort, USP partnered with BSI Management Systems for ISO 9001:2000 certification, and ANSI-ASQ National Accreditation Board/ACLASS for ISO 17025:2005 and Guide 34 RMP accreditation. Both are globally recognized leaders in the certification and accreditation of quality management systems in their respective areas. ISO 9001:2000 RegistrationUSP is officially certified to the ISO 9001:2000 "Quality Management Systems" standard. ISO 9001:2000 certification demonstrates that USP's quality management system provides effective management of internal processes to meet international quality requirements. The ISO 9001:2000 certification resulted from an extensive review of USP's quality management practices by BSI Management Systems. Download ISO 17025 AccreditationISO 17025:2005 "General Requirements for the Competence of Testing and Calibration Laboratories" is an international standard demonstrating that testing and calibration laboratories operate a quality system, are technically competent, and are able to generate technically valid results. The standard covers every aspect of laboratory management, from sample preparation to analytical testing proficiency, record keeping, and reports. It includes reviews of document control, corrective and preventive action, accommodation and environmental conditions, equipment, measurement uncertainty, evidence of traceability, and sampling, and authorizing that USP's testing and calibration results are technically valid. The ISO 17025 accreditation of the USP laboratories resulted from an extensive review of USP's laboratory practices. Download a copy of the ISO 17025:2005 certificate and scope of accreditation for each USP site: Rockville, MD USA
Hyderabad, India
Shanghai, China
ISO Guide 34 Reference Material Producer (RMP) AccreditationISO Guide 34 "General Requirements for the Competence of Reference Material Producers" is an international standard that sets out the general requirements with which a reference material producer must comply if it is to be recognized as competent to carry out the production of reference materials. It is recognized that each reference material needs to be characterized mainly to the level of accuracy required for its intended purpose (i.e. appropriate measurement uncertainty). RMP accreditation not only provides assurance of technical competence and good quality management practices, but demonstrates verification of critical production management of the RMP(s). The accreditation will involve compliance assessment against the requirements not only of ISO Guide 34, but also Guides 30 through 35 as well. In addition, this accreditation typically works in conjunction with ISO 17025. USP received this accreditation as an internationally accredited producer of Certified Reference Materials (CRM). The CRM designation represents additional rigor in the methods used to create, analyze and assign values to reference materials, many of which are well-characterized chemicals that form official USP standards. Download Download |
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Copyright © 2009 The United States Pharmacopeial Convention
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