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IMPLEMENTING AN ISO 9001 MANAGEMENT SYSTEM IN PROCESSES OF ADDITIVE MANUFACTURING FOR MEDICAL USE

2015; INSTITUTO FEDERAL DE SÃO PAULO; Volume: 6; Issue: 4 Linguagem: Inglês

10.14807/ijmp.v6i4.344

ISSN

2236-269X

Autores

Ketinlly Yasmyne Nascimento Martins, Kléber Cavalcanti Nóbrega, Nadja Ma da Silva Oliveira Brito, Rodolfo Ramos Castelo Branco, Jorge Vicente Lopes da Silva,

Tópico(s)

Quality and Safety in Healthcare

Resumo

Based on a case study, this paper presents a methodology to adopt ISO 9001 standards for organizations which make use of additive manufacturing to build products for medical use. Starting with a conceptual model, guidelines were identified to guide planning and operation of the management system, as well as its maintenance and improvement.

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