JIS Q 13485:2005被替代
Medical devices - Quality management systems - Requirements for regulatory purposes
出版：Japanese Standards Association
專家解讀視頻
基本信息
標準編號： JIS Q 13485:2005
發布時間：2005/10/1 0:00:00
標準類別：Standard
出版單位：Japanese Standards Association
標準頁數：58
標準簡介
This Standard specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.
等同采用的國際標準
ISO 13485:2003 - Identical
