標準號：ISO/TR 14969-2004
中文標準名稱：醫療裝置.質量管理系統.ISO 13485-2003應用指南
英文標準名稱：Medical devices - Quality mangement systems - Guidance on the application of ISO 13485: 2003
標準類型：C30
發布日期：1999/12/31 12:00:00
實施日期：1999/12/31 12:00:00
中國標準分類號：C30
國際標準分類號：03.120.10;11.040.01
適用范圍：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.