Statistical analysis on findings in the quality management system during inspection of IVD manufactures of China / 中国医疗器械杂志
Chinese Journal of Medical Instrumentation
; (6): 433-437, 2012.
Article
em Zh
| WPRIM
| ID: wpr-342909
Biblioteca responsável:
WPRO
ABSTRACT
<p><b>OBJECTIVE</b>To explore the current state and the mainly typical problems and vulnerable parts existed in the quality management systems (QMS) of local in vitro diagnostic reagent manufactures.</p><p><b>METHOD</b>To statistical analyze the problems found in the quality management system of in vitro diagnostic reagent manufactures through inspection organized by CCD, SFDA during the second half year of 2011.</p><p><b>RESULTS</b>The total level of the QMS of local IVD manufacturers has risen greatly in past recent years, but a lot of problems still existed. The main vulnerable issues existed in QMS of IVD are documentation and recorder control, design control and validation, producing process control, as well as monitoring and quality control etc, to which should be paid more attention in the future improvement made by the enterprises and supervision by the administration authorities.</p>
Texto completo:
1
Índice:
WPRIM
Assunto principal:
Vigilância de Produtos Comercializados
/
Controle de Qualidade
/
Padrões de Referência
/
China
/
Interpretação Estatística de Dados
/
Indicadores e Reagentes
Tipo de estudo:
Diagnostic_studies
País/Região como assunto:
Asia
Idioma:
Zh
Revista:
Chinese Journal of Medical Instrumentation
Ano de publicação:
2012
Tipo de documento:
Article