Iso 13485:2003

Abstract

If you would like to write for this, or any other Emerald publication, then please use our Emerald for Authors service information about how to choose which publication to write for and submission guidelines are available for all. Please visit www.emeraldinsight.com/authors for more information. About Emerald www.emeraldinsight.comEmerald is a global publisher linking research and practice to the benefit of society. The company manages a portfolio of more than 290 journals and over 2,350 books and book series volumes, as well as providing an extensive range of online products and additional customer resources and services.Emerald is both COUNTER 4 and TRANSFER compliant. The organization is a partner of the Committee on Publication Ethics (COPE) and also works with Portico and the LOCKSS initiative for digital archive preservation. Abstract Purpose -The purpose of this paper is to provide an understanding on implementation and operation of ISO 13485:2003 -"Medical Devices -Quality Management System -Requirements for Regulatory Purposes" -in the perspective of medical device industries in Malaysia. The study is focused on the Malaysian Small and Medium Enterprises (SMEs) which currently have accredited to ISO 9001:2000 quality management systems. Design/methodology/approach -Literature research and comparative analysis between ISO 13485:2003 and ISO 9001:2000 standard and requirements. A reference model is developed to assist the Malaysian SMEs towards ISO 13485:2003 accreditation.Findings -Unlike ISO 9001:2000, ISO 13485:2003 stresses the safety and efficacy of medical devices that are being produced. For this reason risk management is an essential process that needs to be adopted into the ISO 13485:2003 quality management system. Moreover, to demonstrate the effectiveness of the ISO 13485:2003 implementation, this standard has placed great emphasis on documentation requirements which are more prescriptive in insisting on the use of formal procedures. Originality/value -The paper provides guidelines to ISO 13485:2003 implementations as well as risk management approaches for small and medium-sized businesses of Malaysian medical device manufacturers, which at the same time maintains its ISO 9001:2000 certification.

Pengembangan Mobile Learning Barusikung Berbasis Android pada Materi Bangun Ruang Sisi Lengkung

“…Kenyataan yang menunjuk bahwa banyak siswa mengalami kesulitan dalam materi geometri juga dapat dilihat dari hasil survei Programme for Internasional Student Assessment (PISA) (2000) yang menunjukkan bahwa siswa lemah dalam materi tersebut, khususnya dalam pemahaman bentuk dan ruang. Padahal bentuk dan ruang mempunyai pengaruh positif terhadap kesuksesan siswa dalam memahami bentuk abstrak sebuah bangun ruang termasuk unsur dan sketsanya (Alias dkk., 2002;Afriansyah, 2015;Razak & Kamaruddin, 2018;Mulyo, Sari, & Syarifuddin, 2019;Nanang & Sukandar, 2020).…”

Análise da contribuição da indústria 4.0 para a sustentabilidade

“…mas a partir de 2003 surgia a primeira norma de padronização mundial voltada para dispositivos médicos, a ISO 13485:2003 -Dispositivos Médicos -Sistema de Gestão da Qualidade.Requisitos para propostas regulatórias. A norma abordava com mais ênfase os tópicos de segurança, responsabilidade, gestão de risco e rastreabilidade(RAZAK et al, 2009), considerados como requisitos fundamentais para a indústria de fabricação de próteses ortopédicas.Quanto à regulação de ordem sanitária, a Agência Nacional de Vigilância Sanitária(ANVISA) é o órgão responsável pela regulação dos dispositivos para saúde e seus fabricantes no Brasil. O anuente utiliza de Resoluções da Diretoria Colegiada (RDC) para delimitar os contornos dos processos e produtos a fim de garantir a segurança da aplicação, como a RDC 16:2013 que norteia as Boas Práticas de Fabricação para os fabricantes do segmento e a RDC 185/01 que divide os produtos por grau de risco.…”