ISO/TR 14969:2004 医学装置 质量管理系统 ISO 13485-2003的应用指南

标准编号：ISO/TR 14969:2004

中文名称：医学装置 质量管理系统 ISO 13485-2003的应用指南

英文名称：Medical devices — Quality management systems — Guidance on the application of ISO 13485: 2003

发布日期：2004-10

标准范围

ISO/TR 14969:2004提供了ISO 13485中质量管理体系要求的应用指南。它不会增加或改变ISO 13485的要求。它不包括用作监管检查或认证评估活动基础的要求。本指南可用于更好地理解ISO 13485的要求，并说明可用于满足ISO 13485要求的各种方法和方法。

ISO/TR 14969:2004 provides guidance for the application of the requirements for quality management systems contained in ISO 13485. It does not add to, or otherwise change, the requirements of ISO 13485. It does not include requirements to be used as the basis of regulatory inspection or certification assessment activities.This guidance can be used to better understand the requirements of ISO 13485 and to illustrate some of the variety of methods and approaches available for meeting the requirements of ISO 13485.

标准预览图