Risk based quality management: the way forward to improve quality in medical laboratories

Abstract

Risk based quality management: the way forward to improve quality in medical laboratories Risk based quality management is not new. Many different standards including CLSI standard EP23-A, ISO 14971, ISO 31000, and ISO 22367 address risk management in laboratories. Risk and safety are addressed in quality management systems, introduced to provide accreditation and recog-nition of health care institutions. Laboratory quality is different from other quality targets as quality of a test report begins and ends with the same indi-vidual; the patient. Therefore, it is a closed loop having direct repercussions to the patient. In addition, medical laboratories are unique in safety as there are biohazards and chemical hazards. When managing laboratories, we should ensure patient safety as the top priority while ensuring safety of the employees and the environment. The latest version of ISO15189:2022 standard emphasises more on safety and risks. The pro-bability of hazards occurring should be under-stood, and the repercussions of a risk should be given consideration. Combining probability of occurrence and repercussions of risks will enable laboratories to prioritise and plan actions. This