Quality Policy & ISO Accreditation
USP Quality Policy
The United States Pharmacopeial (USP) Convention improves the health of people around the world through public standards and related programs that help ensure the quality, safety, and benefit of medicines and foods. USP, operating under a rigorous quality management system and practices, is committed to continuous improvement and to providing quality products and services to our customers, volunteers, and stakeholders, with the goal of having the quality of such products and services considered outstanding worldwide.
We strive to not only meet, but exceed, customer, volunteer, and stakeholder needs. To this end, we continually pursue and implement activities designed to increase the quality of our products and services, as well as ensure that USP is the “Standard of Quality.”
To help honor this quality commitment, we actively pursue compliance and registration to relevant standards of the International Organization of Standardization (ISO). Since USP sets quality standards for medicines, food ingredients, and dietary supplements that are used in more than 140 countries, we feel it is crucial that USP itself complies with these international quality standards for its operations.
USP has partnered with BSI Management Systems for ISO 9001:2008 certification and ANSI–ASQ National Accreditation Board for ISO 17025:2005 accreditation. These globally recognized leaders in the certification and accreditation of quality management systems, provide USP with objective, third-party validations of our systems.
Certification to ISO 17100:2015
The translation process for the Spanish edition of the United States Pharmacopeia—National Formulary (USP-NF) is certified to ISO 17100:2015 as of the 40th edition of the USP and the 35th edition of the NF.
Certification to ISO 9001:2008
USP is officially certified to the ISO 9001:2008 “Quality Management Systems” standard. ISO 9001:2008 certification demonstrates that USP's quality management system provides effective management of internal processes to meet international quality requirements. The ISO 9001:2008 certification resulted from an extensive review of USP's quality management practices by BSI Management Systems
Accreditation to ISO 17025:2005
ISO 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.
ISO 17025:2005 Accreditation for each USP site: