The internal audit of the quality management system in a medical devices distributor: a case study

Detalhes bibliográficos
Autor(a) principal: Silva, Alex Sander Lopes da
Data de Publicação: 2021
Outros Autores: Andrade, Jucimar Casimiro de, Benevides, Clícia Maria de Jesus
Tipo de documento: Artigo
Idioma: por
Título da fonte: Research, Society and Development
Texto Completo: https://rsdjournal.org/index.php/rsd/article/view/23999
Resumo: The medical devices market is a sector in which regulatory agencies exert great pressure on quality control and management, in order to prevent damage to individual and collective health. Thus, internal audits are seen as fundamental for monitoring and improving the quality of products, services and quality management systems (QMS). The present study, carried out between January and February 2021, aimed to investigate the impact of AUDIN on the maintenance and improvement of the QMS of a healthcare products distributor located in Salvador/BA. It was observed that the QMS of the case under analysis follows the parameters defined by RDC 16/2013, with the AUDIN results as guidelines for promoting the PDCA cycle. Non-conformities (NC) were identified in 8% of the audited requirements, all with the development of an action plan, survey of corrective and preventive measures and evaluation of effectiveness, showing 60% and 80% effectiveness, after seven and twenty days, respectively, from which it is concluded that AUDIN showed great effectiveness for the detection and correction of NC in the QMS, helping to prevent damage to the individual and collective health of users.
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spelling The internal audit of the quality management system in a medical devices distributor: a case studyAuditoria interna del sistema de gestíon de la calidad en la distribución de productos sanitarios: caso de estudioAuditoria interna do sistema de gestão da qualidade na distribuição de produtos para saúde: estudo de caso Auditoria internaGestión de la calidadSalud pública.Internal auditQuality managementCollective health.Auditoria internaGestão da qualidadeSaúde coletiva.The medical devices market is a sector in which regulatory agencies exert great pressure on quality control and management, in order to prevent damage to individual and collective health. Thus, internal audits are seen as fundamental for monitoring and improving the quality of products, services and quality management systems (QMS). The present study, carried out between January and February 2021, aimed to investigate the impact of AUDIN on the maintenance and improvement of the QMS of a healthcare products distributor located in Salvador/BA. It was observed that the QMS of the case under analysis follows the parameters defined by RDC 16/2013, with the AUDIN results as guidelines for promoting the PDCA cycle. Non-conformities (NC) were identified in 8% of the audited requirements, all with the development of an action plan, survey of corrective and preventive measures and evaluation of effectiveness, showing 60% and 80% effectiveness, after seven and twenty days, respectively, from which it is concluded that AUDIN showed great effectiveness for the detection and correction of NC in the QMS, helping to prevent damage to the individual and collective health of users.O mercado de produtos sanitários é um setor em que os organismos reguladores exercem uma grande pressão sobre o controle e a gestão da qualidade, com o fim de prevenir daños para a saúde individual e coletiva. Assim, as auditorías internas (AUDIN) são consideradas fundamentais para monitorar e melhorar a qualidade dos produtos, serviços e sistemas de gestão da qualidade (SGC). O presente estúdio, realizado entre enero e fevereiro de 2021, tuvo como objetivo investigar o impacto de AUDIN na manutenção e mejora do SGC de um distribuidor de produtos sanitários ubicado em Salvador / BA. Veja que o SGC do caso na análise siguió os parâmetros definidos por el RDC 16/2013, com os resultados do AUDIN como pautas para impulsar o ciclo PDCA. Se identificação de não conformidades (NC) em 8% dos requisitos auditados, todo ello com o desarrollo de um plano de ação, relevamiento de medidas corretivas e preventivas e avaliação de efectividad, mostrando uma efectividad del 60% y 80%, after the siete and veinte. Aí, respectivamente, de los cuales se concluye que o AUDIN mostrou gran efectividad para a detecção e correcção de NC no SGC, ayudando a prevenir daños a la salud individual y colectiva de los usuarios.O mercado de produtos para saúde é um setor no qual as agências regulatórias exercem grande pressão sobre o      controle e a gestão da qualidade, a fim de prevenir danos à saúde individual e coletiva. Assim, as auditorias internas (AUDIN) são apontadas como fundamentais para o monitoramento e o aprimoramento da qualidade de produtos, serviços e sistemas de gestão da qualidade (SGQ). O presente estudo, realizado entre janeiro e fevereiro de 2021, visou investigar o impacto da AUDIN na manutenção e no aprimoramento do SGQ de uma empresa distribuidora de produtos para saúde localizada em Salvador/BA. Observou-se que o SGQ do caso em análise seguia os parâmetros definidos pela RDC 16/2013, tendo os resultados das AUDIN como norteadores para promoção do ciclo PDCA. Foram identificadas não-conformidades (NC) pontuais em 8% dos requisitos auditados, todos com desenvolvimento de plano de ação, levantamento de medidas corretivas e preventivas e avaliação de eficácia, apresentando eficácia de 60% e 80%, após sete e vinte dias, respectivamente, de onde se conclui que a AUDIN apresentou grande efetividade para a detecção e correção de NC no SGQ, auxiliando na prevenção de danos à saúde individual e coletiva dos usuários.Research, Society and Development2021-12-04info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionapplication/pdfhttps://rsdjournal.org/index.php/rsd/article/view/2399910.33448/rsd-v10i16.23999Research, Society and Development; Vol. 10 No. 16; e177101623999Research, Society and Development; Vol. 10 Núm. 16; e177101623999Research, Society and Development; v. 10 n. 16; e1771016239992525-3409reponame:Research, Society and Developmentinstname:Universidade Federal de Itajubá (UNIFEI)instacron:UNIFEIporhttps://rsdjournal.org/index.php/rsd/article/view/23999/20618Copyright (c) 2021 Alex Sander Lopes da Silva; Jucimar Casimiro de Andrade; Clícia Maria de Jesus Benevideshttps://creativecommons.org/licenses/by/4.0info:eu-repo/semantics/openAccessSilva, Alex Sander Lopes da Andrade, Jucimar Casimiro de Benevides, Clícia Maria de Jesus 2021-12-20T11:03:07Zoai:ojs.pkp.sfu.ca:article/23999Revistahttps://rsdjournal.org/index.php/rsd/indexPUBhttps://rsdjournal.org/index.php/rsd/oairsd.articles@gmail.com2525-34092525-3409opendoar:2024-01-17T09:42:41.614426Research, Society and Development - Universidade Federal de Itajubá (UNIFEI)false
dc.title.none.fl_str_mv The internal audit of the quality management system in a medical devices distributor: a case study
Auditoria interna del sistema de gestíon de la calidad en la distribución de productos sanitarios: caso de estudio
Auditoria interna do sistema de gestão da qualidade na distribuição de produtos para saúde: estudo de caso
title The internal audit of the quality management system in a medical devices distributor: a case study
spellingShingle The internal audit of the quality management system in a medical devices distributor: a case study
Silva, Alex Sander Lopes da
Auditoria interna
Gestión de la calidad
Salud pública.
Internal audit
Quality management
Collective health.
Auditoria interna
Gestão da qualidade
Saúde coletiva.
title_short The internal audit of the quality management system in a medical devices distributor: a case study
title_full The internal audit of the quality management system in a medical devices distributor: a case study
title_fullStr The internal audit of the quality management system in a medical devices distributor: a case study
title_full_unstemmed The internal audit of the quality management system in a medical devices distributor: a case study
title_sort The internal audit of the quality management system in a medical devices distributor: a case study
author Silva, Alex Sander Lopes da
author_facet Silva, Alex Sander Lopes da
Andrade, Jucimar Casimiro de
Benevides, Clícia Maria de Jesus
author_role author
author2 Andrade, Jucimar Casimiro de
Benevides, Clícia Maria de Jesus
author2_role author
author
dc.contributor.author.fl_str_mv Silva, Alex Sander Lopes da
Andrade, Jucimar Casimiro de
Benevides, Clícia Maria de Jesus
dc.subject.por.fl_str_mv Auditoria interna
Gestión de la calidad
Salud pública.
Internal audit
Quality management
Collective health.
Auditoria interna
Gestão da qualidade
Saúde coletiva.
topic Auditoria interna
Gestión de la calidad
Salud pública.
Internal audit
Quality management
Collective health.
Auditoria interna
Gestão da qualidade
Saúde coletiva.
description The medical devices market is a sector in which regulatory agencies exert great pressure on quality control and management, in order to prevent damage to individual and collective health. Thus, internal audits are seen as fundamental for monitoring and improving the quality of products, services and quality management systems (QMS). The present study, carried out between January and February 2021, aimed to investigate the impact of AUDIN on the maintenance and improvement of the QMS of a healthcare products distributor located in Salvador/BA. It was observed that the QMS of the case under analysis follows the parameters defined by RDC 16/2013, with the AUDIN results as guidelines for promoting the PDCA cycle. Non-conformities (NC) were identified in 8% of the audited requirements, all with the development of an action plan, survey of corrective and preventive measures and evaluation of effectiveness, showing 60% and 80% effectiveness, after seven and twenty days, respectively, from which it is concluded that AUDIN showed great effectiveness for the detection and correction of NC in the QMS, helping to prevent damage to the individual and collective health of users.
publishDate 2021
dc.date.none.fl_str_mv 2021-12-04
dc.type.driver.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.uri.fl_str_mv https://rsdjournal.org/index.php/rsd/article/view/23999
10.33448/rsd-v10i16.23999
url https://rsdjournal.org/index.php/rsd/article/view/23999
identifier_str_mv 10.33448/rsd-v10i16.23999
dc.language.iso.fl_str_mv por
language por
dc.relation.none.fl_str_mv https://rsdjournal.org/index.php/rsd/article/view/23999/20618
dc.rights.driver.fl_str_mv https://creativecommons.org/licenses/by/4.0
info:eu-repo/semantics/openAccess
rights_invalid_str_mv https://creativecommons.org/licenses/by/4.0
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
dc.publisher.none.fl_str_mv Research, Society and Development
publisher.none.fl_str_mv Research, Society and Development
dc.source.none.fl_str_mv Research, Society and Development; Vol. 10 No. 16; e177101623999
Research, Society and Development; Vol. 10 Núm. 16; e177101623999
Research, Society and Development; v. 10 n. 16; e177101623999
2525-3409
reponame:Research, Society and Development
instname:Universidade Federal de Itajubá (UNIFEI)
instacron:UNIFEI
instname_str Universidade Federal de Itajubá (UNIFEI)
instacron_str UNIFEI
institution UNIFEI
reponame_str Research, Society and Development
collection Research, Society and Development
repository.name.fl_str_mv Research, Society and Development - Universidade Federal de Itajubá (UNIFEI)
repository.mail.fl_str_mv rsd.articles@gmail.com
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