本书适用于那些负责寻求符合医疗设备质量管理体系标准ISO 13485要求的人。本标准有许多方面与ISO 9001相同，这意味着可以相对容易地同时获得两个标准的认证。此外，ISO 9001的持续改进可以为制造和服务医疗设备的人提供真正的收益和竞争优势。本书向读者介绍了这两个标准的条款，提供了有关ISO 13485、ISO 9001和质量管理体系审核的基本信息。 交叉引用:ISO 13485ISO 9001

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.Cross References:ISO 13485ISO 9001