標準號：BIP 2071-2005
中文標準名稱：醫療器械:ISO 13485和ISO 9001
英文標準名稱：Medical devices: ISO 13485 and ISO 9001
標準類型：C30
發布日期：2005/6/1 12:00:00
實施日期：2005/6/1 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 book is for those who are responsible for seeking compliance with the requirements of the quality management systems standard ISO 13485 on medical devices. There are many aspects of this standard that are identical to ISO 9001, meaning that accredited certification to both standards can be achieved at the same time, relatively easily. In addition the continual improvement aspect of ISO 9001 can offer real gains and competitive advantage to those who manufacture and service medical devices. The book takes the reader through the clauses of both standards, providing essential information on ISO 13485, ISO 9001 and quality management system auditing.