PIMENTEL, C. A.; http://lattes.cnpq.br/2241223148404540; PIMENTEL, Cristiane Agra.
Résumé:
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.
