ISO/TR 14969:2004《医疗器械质量管理体系YY/T0287-2003应用指南》简介

Introduction of ISO/TR 14969:2004 Medical devices-Quality management systems-Guidance on the application of YY/T0287-2003

YY/T 0287-2003《医疗器械质量管理体系用于法规的要求》是医疗器械行业的质量管理体系的认证标准,最新国际标准ISO/TR 14969:2004为上述标准的应用提供了指南,本文对其做了简单介绍。

YY/T0287-2003 quality management system using in regulation's request is a certification standard for the quality management system of medical devices sector. The new international standard ISO/TR 14969:2004 provides a enchiridion of it. This article gives a brief introduction about it.