Definitions used in quality management of blood establishments: A report of the ISBT Quality Management Working Party.

Background and objectives: The International Society of Blood Transfusion (ISBT) Quality Management Working Party (QM-WP) initiated a project to harmonize the definitions commonly used in quality management within blood establishments (BEs) around the world. A working group was established with the aim of providing simple, unambiguous definitions that can be applied in a standardized way.

Materials and methods: Common references available internationally were consulted in drafting a list of definitions relating to quality management. The criteria for selecting the most appropriate definition included clarity, simplicity, comprehensiveness and optimal applicability.

Results: The resulting list of definitions was published on the ISBT website in July 2023, with reference sources quoted for each definition. Individual references can be accessed via links appearing at the end of the document.

Conclusion: BEs are encouraged to utilize the document when developing internal quality system documents. The list is not prescriptive but is meant to serve as a recommendation. It is understood, however, that establishments in some countries are obliged to follow national legislation and terminology. It is the intention of the ISBT QM-WP to periodically review the list of definitions, performing updates when required.