Transcription of Medical devices — Quality management systems ...
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Medical devices — Quality management systems ...
international ISO. STANDARD 13485. Second edition 2003-07-15. Medical devices Quality management systems Requirements for regulatory purposes Dispositifs m dicaux Syst mes de management de la qualit . Exigences des fins r glementaires Reference number ISO 13485:2003(E). ISO 2003. ISO 13485:2003(E). PDF disclaimer This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing.
ISO 13485:2003(E) © ISO 2003 — All rights reserved v 0 Introduction 0.1 General This International Standard specifies requirements for a quality management system that can be used by an
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