STANDARD OPERATING PROCEDURES FOR QUALITY AUDITS OF60Co EXTERNAL BEAM RADIOTHERAPY FACILITIES

摘要

The use of the radiotherapy implies the necessity of rigorous quality standards in its different components, aimedrnto provide the best possible treatment and avoid potential patient’s risks, that could even causing him the death.rnProjects of technical cooperation had been developed in Cuba support by the International Atomic EnergyrnAgency addresses to the implementation of Programs of Quality Assurance (PGC) in radiotherapy services. Thernestablishment of the National Quality Audit Program (PNAC) is a superior stage. The National Control Centerrnfor Medical Devices as the national regulator entity for the control and supervision of medical devices in thernNational Health System is the responsible for the making and execution of the PNAC. The audit modalityrnselected was the inspection visit in situ due to its intrinsic advantages, our geographical extension and the numberrnof radiotherapy services. This paper presents the methodology for the execution of the PNAC, in form of arnNormalized Procedure of Operation (PNO) that defines the objectives, scope, terms and definitions,rnresponsibilities, composition and selection of the auditor team, security’s conditions, materials and equipment,rnsteps of the audit execution, results calculation and interpretation, records, etc.