Healthcare quality and ISO/IEC 17020
Abstract Medical devices with a measuring function have to be periodically inspected. Periodical inspection of these devices is necessary to protect the end users as well as personnel who use them for establishing diagnoses for patient treatment. Incorrect and imprecise measuring results can lead to misdiagnosis, and therefore to wrong treatment. To avoid these unwanted situations, medical devices with the measuring function have to be regularly inspected in accordance with the prescribed inspection procedures. These procedures have to be approved by a state authorized body responsible for this area. Also, medical devices with measuring function in some countries are a part of the legal metrology system. Because of the high importance of these devices, their inspection needs to be carried out by inspection bodies with proven competences. The most reliable way of proving competences is through the fulfillment of requirements resulting from ISO/IEC 17020. This chapter briefly elaborates on the requirements arising from this standard as well as the mode for its implementation. This chapter aims to facilitate the implantation of the ISO/IEC 17020 standard for future inspection bodies for performing the inspection in a competent and impartial manner. Accurate and precise medical devices with measuring function will enable professional personnel to properly establish diagnoses for patient treatment. There are many advantages of regular inspection of medical devices, and the greatest advantage is the protection of the patient’s lives.