Quality Policy & ISO Accreditation
USP Quality Policy
At USP, our commitment to quality resonates in our 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/ACLASS for ISO 17025:2005 and Guide 34 RMP 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 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 certificates and scopes of accreditation for each USP site:
- Rockville, MD, USA
- Hyderabad, India
- Shanghai, China
- São Paulo, Brazil
Accreditation to ISO Guide 34 Reference Material Producers (RMP)
ISO 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.