Guia para implantação de sistema de gestão da qualidade em setores de engenharia clínica de hospitais – Atendimento aos requisitos das normas ABNT NBR ISO 9001:2015 e ABNT NBR 15943:2011

Abstract

The objective of this work was to create a managerial practice tool that could assist Clinical Engineering professionals in performing their activities in hospital units, through the implementation of a Quality Management System applied to Health Technology Management. In order to achieve this objective, a guide for the implementation of the Quality Management System (QMS) was developed based on the ISO 9001: 2015 standard and on compliance with the provisions of the ABNT NBR 15943: 2011 standard, which addresses the guidelines for a health equipment management program. This Guide aims to assist hospital health professionals in the use of internationally accepted and recognized practices for quality management, as well as the application of good health equipment management practices, with the purpose of improving the quality of processes and engineering services in hospitals. A literature review was carried out to collect specific knowledge related to quality management and health equipment management. Then, for the development of the methodology, all the requirements of the two mentioned standards were studied and analyzed and a template tool was used to develop the proposed Guide, resulting in the elaboration and use of 52 documents, separated in 19 appendices and 33 attachments. All the documents prepared were correlated, through a single document, the Quality Manual (Model). The Quality Manual developed, in addition to bringing a step by step to the implementation of t he quality management system, also brings to the reader explanations about the requirements of ISO 9001: 2015 and practical examples of activities related to the requirements of the ABNT standard NBR 15943: 2011.