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医疗器械生产质量管理规范
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2009年12月16日,国家食品药品监督管理局就发布了《医疗器械生产质量管理规范(试行)》;《医疗器械生产质量管理规范检查管理办法(试行)》。2014年2月12日国务院审议通过《医疗器械监督管理条例(修订草案)》。此后,国家总局的《医疗器械生产监督管理办法》更加详细地规定了医疗器械生产企业建立生产质量管理体系的要求。作者岳伟参加了《医疗器械生产质量管理规范》及其两个《实施细则》的起草工作。在长年工作中,几乎每天都会接到许多电话或...
2009年12月16日,国家食品药品监督管理局就发布了《医疗器械生产质量管理规范(试行)》;《医疗器械生产质量管理规范检查管理办法(试行)》。2014年2月12日国务院审议通过《医疗器械监督管理条例(修订草案)》。此后,国家总局的《医疗器械生产监督管理办法》更加详细地规定了医疗器械生产企业建立生产质量管理体系的要求。作者岳伟参加了《医疗器械生产质量管理规范》及其两个《实施细则》的起草工作。在长年工作中,几乎每天都会接到许多电话或邮件咨询,要求讲解上述这些规范及其细则的条款。不解决这些问题,不解决企业的疑问,必然会对全面执行新法规、全面推行质量管理规范、全面促进医疗器械产业创新发展产生影响。《<医疗器械生产质量管理规范>的解析和应用》出版,对解决以上问题,大有帮助。
岳伟,男,1955年1月出生。毕业于上海市第二工业大学,工学学士。长期从事于医疗器械工业生产的科研、管理。曾经担任上海医用核子仪器厂技术副厂长、上海医用激光仪器厂技术副厂长;自1990年代末从事医疗器械行政管理工作,担任上海市医药管理局科学技术处、对外经济合作处主任科员;上海市医药管理局综合处副处长;上海市食品药品监督管理局办公室副主任、信息中心主任。原上海市食品药品监督管理局医疗器械监管处处长。 现受聘为: ·上海医疗器械行业协会法务咨询顾问; ·国家食品药品监督管理总局高级研修学院客座教授; ·上海医疗器械高等专科学院客座教授; ·上海市科委科学技术专家; ·上海市浦东新区科技局科学技术专家; ·国家免费计划生育药具政府采购评审专家; ·张江专项发展资金专家等。
前言绪论章 总则第二章 机构与人员第三章 厂房与设施第四章 设备第五章 文件管理第六章 设计开发第七章 采购第八章 生产管理第九章 质量控制第十章 销售和售后服务第十一章 不合格产品控制第十二章 分析和改进第十三章 附则附录 医疗器械生产质量管理规范
在我长期的医疗器械管理工作中,对企业的质量管理体系的建立和运行占了较大的比重,具有了丰富的经历,也积累了一些经验。早在1985年,我在上海医用核子仪器厂担任技术副厂长时,我们工厂因为生产蒸汽压力消毒器而需要申请类压力容器生产许可证。在申请压力容器生产许可证和接受劳动安全监管部门组织的认证过程中,从产品设计文件、质量管理文件、原材料采购和检验、生产过程中的质量控制、生产过程的记录等各个方面做了大量的工作。现在回忆起来,实际上就是为压力容器的生产建立了一套完整的质量管理体系。那个时候,为了建立质量管理手册、为了建立金属材料实验室、为了对压力容器进行无损探伤等等,进行了大量的工作。虽然顺利地完成了取证的任务,但是对质量管理体系还是似懂非懂。1987年我国的GBlT19000系列质量管理体系标准正式发布以后,在全国掀起了一次宣传和学习的高潮,这时我已经担任了上海医用激光仪器厂的技术副厂长,所以在组织学习、贯彻实施中也做了许多工作。但是,真正对医疗器械生产质量管理体系的理解,是在2005年参加了国家认证认可机构组织的质量管理体系审核员学习和考核。通过系统地学习质量管理体系审核知识和质量管理体系标准,并经过实习审核员和正式审核员的考核,获得了国家审核员的资格。从2005年起,我担任上海市食品药品监督管理局医疗器械监管处处长的职务,直接担当起在上海市医疗器械行业推进建立医疗器械生产质量管理体系的工作。在十几年持续的工作中,不断地学习,不断地实践,并参加了国家相关医疗器械生产质量管理规范文件的研究、起草、解释、实施的工作。在长期的工作实践中,看到我国医疗器械生产企业随着质量管理规范的推行,企业的质量管理水平不断提高,医疗器械产品的水平也在不断提高,对此颇有感触。同时也看到在实施医疗器械生产质量管理规范中,产生了许多矛盾和问题,也有许多误解和误判,也对一些企业造成了伤害和损失。所以,在今天国家食品药品监督管理总局再次发布《医疗器械生产质量管理规范》时,我产生了一个强烈的想法,总结几十年来自己工作的经验和处理过的案例,对《医疗器械生产质量管理规范》的具体内容做一个原理上的解析,以求准确、全面地理解每一条款的基本原理和内涵。同时,对每一条款在执行应用中的要点,所涉及的范围和内容,需要引用的法规或知识等写出来。结果就写成了本书。
在2015年全国“两会”上,总理提出,在行政管理上应当“大道至简,有权不可任性”。在医疗器械质量体系的管理上也应当树立这种理念。特别是对行政检查人员而言,一定要把医疗器械生产企业的质量管理体系的精髓理解清楚,做到科学、适宜、实事求是。我们应当特别注意,在检查质量管理体系时,当向生产企业提出存在“不合格”或者“严重缺陷”时,就应当有能力说明什么是“合格”或者“正确的应当如何”。这样企业才会信服,也会不断提高质量管理体系的水平。所以,如果本书能够让检查员说出不任性的,而是科学的检查结果,我将很欣慰。
在写本书的时候,我也是顾虑重重,因为我的文字水平不高,论述非常直白。至今在《医疗器械生产质量管理规范》的学习宣讲上,尚没有人展开进行权威解说,所以感到自己有点不知天高地厚,不自量力。再加上自己认识能力十分有限,常有管窥之见,还存在一些偏见。所以,很可能本书出版之后,会引起很多争论,也有人会否定我的部分观点。但是,仔细一想,如果本书出版以后,能够引起同行的议论,终使得国家行政监管的权威部门对实施《医疗器械生产质量管理规范》做出权威、详尽的解说,何尝不是一件好事啊。
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