Metodologia para adoção de sistemas de gestão baseada na ISO 9001 em organizações de manufatura aditiva aplicadas à saúde

Abstract

This study aimed to present a methodology for implementation of Quality Management Systems (QMS) based on ISO 9001 for Additive Manufacturing organizations (MA) in health. The research was motivated by the need that the 3D Technologies Laboratory (LT3D) of the Center for Strategic Technologies in Health - NUTES presented in improving the quality of processes it has played, through the implementation of a QMS. To achieve this goal, specific objectives in order to assist the implementation were developed. One was the application of a case study in Three-dimensional technologies division (DT3D) of Renato Archer's Information Technology Center (CTI), which is certified by ISO 9001. The Other was the creation of a system design showing all the activities necessary for the production of biomodel which is the product manufactured in LT3D through MA, and correlate with the requirements of ISO 9001: 2008, thereby facilitating the understanding of the whole process. Also it took place throughout the modeling of business process through management model by BPM Business Process (Business Process Management) through the BPMN notation (Business Process Model and Notation). The steps of the proposed methodology were guided to make clear the activities critical to implementing a QMS, this model differs from the others by having the step of a system design that correlates all business process events for the production of biomodel, with requirements ISO 9001: 2008 , making it easier to understand what you want to have as a focus for implementation of a QMS for Additive Manufacturing organizations in health.