Auditoría de la calidad a los procesos del laboratorio clínico de la Cruz Roja Ecuatoriana de la junta provincial de Chimborazo bajo los estándares ISO 9001-2015, cantón Riobamba, periodo 2019

Abstract

This research project is an improvement proposal through the implementation of a Quality audit of procedures, based on the ISO 9001: 2015 standard, focused on section 8 (Operation), to the Clinical Laboratory area of the Ecuadorian Red Cross from the Provincial Board of Chimborazo, located in Riobamba city. The proposal starts from an initial diagnosis in the Clinical Laboratory, in which it exhibits irregularities by the compliance of mandatory ISO 9001: 2015, it is stated that the procedures manual which is applied in the activities is outdated for its implementation, causing not only labor risks they also cause displeasure to users who receive the service, it is taken into account that one of the main causes is the lack of its procedures manual in the entity, together there is also the professional negligence with patient diagnosis and treatment complications as well as incipience of equipment necessary for the DNA sample analysis, linked to apathy in personal biosecurity in collaborators. An evaluation procedure was established giving as a result of a level of compliance in clinical laboratory processes according to systematic ISO 9001: 2015, it is confirmed that 68% is acceptable based on the regulations established by the organization, and agencies that support health that is, on the other hand, 30% partially comply because there is no planning that shows that it has been imparted to the collaborators, there is also no adequate control to the management that implement emergency plans, supporting biosecurity, allowing risk reduction and paying attention to complaints or suggestions of users, 4% do not apply aspects within the present