Standard procedure of operation for the accomplishment of audit of quality in facilities of teletherapy with isotopic units of 60Co

The use of the radiotherapy implies the necessity of rigorous quality standards in its different components, aiming to provide the best possible treatment and avoid potential patient's risks, that could even cause his/her death. Projects of technical cooperation have been developed in Cuba support by the International Atomic Energy Agency addresses to the implementation of Programs of Quality Assurance in radiotherapy services. The establishment of the National Quality Audit Program (PNAC) is a superior stage. The National Control Center for Medical Devices as the national regulator entity for the control and supervision of medical devices in the National Health System is the responsible for the making and execution of the PNAC. The audit modality selected was the inspection visit in situ due to its intrinsic advantages, our geographical extension and the number of radiotherapy services. This paper presents the methodology for the execution of the PNAC, in form of a Normalized Procedure of Operation that defines the objectives, scope, terms and definitions, responsibilities, composition and selection of the auditor team, security's conditions, materials and equipment, steps of the audit execution, results calculation and interpretation, records, etc. (author)