Clinical and Laboratory Standards Institute guideline QMS21—Purchasing and Inventory Management provides laboratories with guidance on developing processes for qualifying and selecting suppliers of laboratory equipment, instruments, reagents, consumable materials, other products, and services obtained from external sources; procuring, receiving, and managing inventory; and monitoring supplier performance. Laboratories need efficient and effective purchasing and inventory management processes to provide timely and high-quality services to their customers and meet regulatory, accreditation, and customer requirements.

This guideline is applicable to medical laboratories of any size, complexity, or specialty, including point-of-care testing (POCT). However, because the concepts behind purchasing and inventory requirements are generic, other types of laboratories, such as public health, research, food, environmental, and veterinary laboratories, can also use this guideline.

This guideline provides information for procuring equipment, instruments, reagents, consumable materials, other products, and services from external sources and also provides information about inventory management processes for externally procured or internally prepared items. Chapter 5 presents key features of electronic inventory management systems.

This guideline references procurement and inventory management of blood components and cellular therapy products but does not provide technical details. However, the purchasing and inventory management concepts presented in this guideline can be used by laboratories that support provision of these products.

QMS21 is a guideline for how to implement requirements established in international standards, and by regulatory and accrediting organizations for managing laboratory work processes. QMS21 is not a standard; that is, this guideline does not set requirements for purchasing and inventory management processes and procedures. Instead, this guideline describes what laboratories need to do to meet published regulations, accreditation requirements, and international standards2-13 for purchasing and inventory management, and provides suggestions and examples for fulfilling the requirements.

This guideline does not provide detailed information on how to make a business case for the purchase of expensive capital items such as equipment, instruments, test systems, or information systems. It does not discuss the purchase of other business units.