Diagnóstico para acreditação na norma NBR ISO-IEC 17025:2005: estudo de caso das próteses mamárias no laboratório CERTBIO.

Abstract

Biomaterials produced to be applied as medical devices must attend the requirements of quality, safety and efficacy. In this context includes breast implants. The standardization processes in laboratories responsible for the certification of these biomaterials through the implementation of specific rules have major impact on process quality and safety and strategic performance of laboratories. Thus, this study aims to conduct a diagnosis at CERTBIO Laboratory to have an accreditation process on breast implants in the standard ISO / IEC 17025: 2005. An addition study at technical part was conducted to see the performance of suppliers at volatile material determination and validation the method of this test. In terms of methodology we conducted a case study of descriptive and exploratory nature. The results demonstrate that the implementation of the above requirement associated with a management system in the certification process of breast implants in CERTBIO, promoted the reduction in the delivery performance, greater standardization of processes, greater customer satisfaction and better control the supply procurement process. Moreover, in the part of technical studies, it was shown that all suppliers have attended to the determination of volatile matter test specification, but the number 1 was extremely better performance as to the results; however it did not see any difference between these variances. While the validated test of this method, recommended to continue analyzing gel and membrane. Thus, it could be proved that after accreditation process, the CERTBIO laboratory has become an international reference in biomaterials , as well as excellence in quality and reliability of the services performed.