ISO/TR 14969-2004 医疗装置.质量管理系统.ISO 13485-2003应用指南

标准号：ISO/TR 14969-2004
中文标准名称：医疗装置.质量管理系统.ISO 13485-2003应用指南
英文标准名称：Medical devices - Quality mangement systems - Guidance on the application of ISO 13485: 2003
标准类型：C30
发布日期：1999/12/31 12:00:00
实施日期：1999/12/31 12:00:00
中国标准分类号：C30
国际标准分类号：03.120.10;11.040.01
适用范围：This Technical Report provides guidance for the application of the requirements for quality managementsystems contained in ISO 13485. It does not add to, or otherwise change, the requirements of ISO 13485.This Technical Report does not include requirements to be used as the basis of regulatory inspection orcertification assessment activities.NOTE The terms “should”, “can” and “might” within this Technical Report are used as follows. “Should” is used toindicate that, amongst several possibilities to meet a requirement in ISO 13485, one is recommended as being particularlysuitable, without mentioning or excluding others, or that a certain course of action is preferred but not necessarily required.“Can” and “might” are used to indicate possibilities or options. These terms do not indicate requirements.This guidance can be used to better understand the requirements of ISO 13485 and to illustrate some of thevariety of methods and approaches available for meeting the requirements of ISO 13485.