如何把握质量体系认证在医疗设备招标中的实用价值  

Value of Quality System Certification for Medical Equipment Bidding

作　　者：王晓坤[1] 宋晓英[1] 杨晓亚[1] 

机构地区：[1]解放军451医院,西安710054

出　　处：《医疗卫生装备》2013年第3期117-118,122,共3页Chinese Medical Equipment Journal

摘　　要：目的:针对政府集中招标出现的各种现象,剖析深层次的原因,找出应对的方法和改进措施,澄清对质量管理体系认证的含混知识。方法:采用对比、层层递进的方式明确指出了质量管理体系认证的必充性。结果:科学、客观地论证了质量管理体系的可靠性、实用性,准确、详实地阐明了ISO 13485发展的历史进程。结论:使评委在评标过程做到心中有数、赋分有据,进一步提升了政府集中采购的公信力,体现了质量管理体系的价值。Objective To make clear the quality system certification to improve medical equipment bidding.Methods The non-essential nature of the quality system certification was discussed by comparison and recursion.Results The reliability and practicality of the quality system certification were demonstrated,with the history of ISO13485 described.Conclusion The bidding of medical equipment is facilitated by the understanding of the quality system certification,with the enhanced credibility of the government centralized procurement.

关 键 词：质量管理体系 ISO 13485 政府招标 

分 类 号：R197.39[医药卫生—卫生事业管理] F203[医药卫生—公共卫生与预防医学]