- 期刊
ISO 13485:2016年版醫療器材品質管理系統新版解析
Analysis of the new version ISO 13485:2016 Medical Devices QMS Standard
參考文獻
ISO 13485:2016, Medical devices - Quality management systems - Requirements for regulatory purposes.
ISO 13485:2003, Medical devices - Quality management systems -Requirements for regulatory purposes.
ISO/TC 210/WG 1 N 233 wg1N233 Draft White Paper-ISOTransition Planning Guidance for ISO13485:2016