USP Quality Policy
At USP, our Quality Policy is defined and driven by the following organizational principles:
We rely on robust public input and independent, scientific decision-making to develop and deliver standards, programs and services which are timely, effective, and meet or exceed our users’ needs and expectations.
We build mutually beneficial relationships with our customers, stakeholders and volunteers to advance our shared public health goals.
We drive continual improvement based on applicable requirements, a rigorous quality management system, well-defined measurements, best practices, and user feedback.
We reinforce the use of best preventive practices at all levels and ensure reliable risk management.
We achieve our public health mission through our ongoing commitment to these principles.
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 the following international quality standards for its operations.
USP has partnered with TUV Rheinland for ISO 9001:2015 certification and ANSI–ASQ National Accreditation Board for ISO 17025-2017 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 9001:2015
USP is ISO 9001:2015 certificated with TUV Rheinland. USP's quality management system provides effective management of internal processes to meet international quality requirements. The ISO 9001:2015 certification resulted from an extensive review of USP's quality management practices.
Accreditation to ISO 17025:2017
ISO 17025:2017 “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 17025:2017 Accreditation for each USP site:
- USP–U.S.: ISO 17025:2017 Accreditation (Rockville)
- USP–India: ISO 17025:2017 Accreditation (Hyderabad)