Desenvolvimento de metodologia para aplicação dos requisitos da ISO 13485, da RDC ANVISA 665/2022 e do programa MDSAP em sistemas de gestão da qualidade

Abstract

INTRODUCTION: Adapting or implementing a Quality Management System (QMS) in accordance with applicable standards and resolutions is a challenge for many companies, factories, laboratories, and technology centers. This is partly because these standards and resolutions do not describe how their requirements must be met. Instead, they provide general guidelines that are not always correctly interpreted by organizations. In the context of the healthcare sector, this problem intensifies because the set of requirements to implement or adapt a QMS aimed at medical devices, considering the nature of these products, is complex and requires the application of rigorous quality processes throughout the organizational structure. Additionally, it is necessary to comply with more than one regulation at the same time. From this perspective, the present work aims to develop a methodology that establishes steps and describes methods to apply, in any QMS linked to medical devices, the requirements of ISO 13485 and RDC ANVISA resolution nº 665/2022, individually or together, as well as well as the Medical Device Single Audit Program (MDSAP) with commercialization scope for Brazil. In addition, this work describes the case study used to verify the effectiveness of this methodology. In this case study, the QMS of the Medical Device Manufacturing Unit (UFDM) of the Center for Strategic Health Technologies (NUTES) of the State University of Paraíba (UEPB) was adapted according to the proposed approaches and was then subjected to processes auditing necessary to obtain the Certification of Good Manufacturing Practices (CBPF) from Anvisa via the MDSAP program and the certification of the ISO 13485 standard. OBJECTIVES: To develop and establish, in a case study, a methodology for applying the requirements of ISO 13485, RDC ANVISA No. 665/2022, and/or the MDSAP program to quality management systems of healthcare sector organizations. METHODOLOGY: The research in this work adheres to a qualitative approach, outlined through a case study. RESULTS AND DISCUSSIONS: The results of this work include a correlation matrix between terms of resolution RDC ANVISA No. 665/2022 and ABNT NBR ISO 13485:2016 that have the same meaning; a sequence of stages for implementing the requirements of the MDSAP program and/or RDC ANVISA No. 665/2022 and ABNT NBR ISO 13485:2016, separately or together; as well as a guide with practical approaches for applying the requirements of these regulations. Additionally, the description of the conducted case study, which contains information about the NUTES Medical Device Manufacturing Unit, and the challenges faced during the audit and certification processes, is also considered part of the results. CONCLUSION: The proposed methodology was successfully developed. Proof of this is that the UFDM QMS was subjected to certification audits and no non-compliance was detected by external auditors. As a result, NUTES obtained both the Good Manufacturing Practices Certification from Anvisa via the MDSAP program and the certification relating to ISO 13485.