As discussed in the Laboratory Quality Management Systems Handbook6, CLSI, CDC, and WHO have addressed 12 quality system essentials in the quality management system model. These 12 system essentials are the building blocks for laboratory quality management. This model was developed to be compatible with International Organization for Standardization (ISO) laboratory standard, ISO 15189. (ISO 15189 is an international standard, not mandatory in the United States, but highly recommended. In contrast, adherence to the Clinical Laboratory Improvement Amendments [CLIA] is mandatory in the US.) A strong supporting organizational structure, as well as competent laboratory management and staff, must be involved in the provision of necessary resources required to drive the quality management system and to continually improve the system's effectiveness.
Purchasing and inventory are listed as one segment of 12 quality system essentials, useful for obtaining the previously mentioned items, personnel, and services needed to keep a clinical laboratory working...in addition to careful management of inventory and providing efficient and cost-effective high-quality laboratory operations.
To provide standardization among medical laboratories, ISO 15189 was developed in 2003 as an international standard. It has been revised several times since its inception. ISO 15189 contains sections for organization, management, personnel, and laboratory equipment. While additional sections specifically address purchasing and inventory such as contract review, referral laboratories, and external services and supplies - the building block where vendor relationships occur. Adequate processes must be in place.7
