摘要
目的:探讨检验/检测机构标准查新和标准确认的管理模式。方法:根据我所检验(检测)/标准(方法)控制管理的实践经验,从标准库的建立与完善、标准变更确认管理、标准查新的落实与监督检查机制、工作中遇到的问题及解决方法等4个方面进行探讨分析。结果与结论:重视标准变更后的方法确认和方法验证工作;加强标准查新和标准确认管理,使其真正发挥预防措施的作用;主动关注和追踪国内、国际食品药品安全领域的重大事件和问题产品在国际上的技术检测标准,为决策层安排实验室新项目的扩项和配置足够的资源做准备,以真正做到满足为社会大众和政府监管服务的要求。
Objective：To discuss the management model of standard novelty search and standard conifrmation for inspection/testing institutions. Methods：Based on our practical experience of the inspection （testing）/standard （method） control management, the following 4 aspects were discussed： establishment and improvement of standard library;management of the conifrmation for the standard changing;implementation and supervision of standard novelty search;problems and solutions in work. Results and Conclusion：Institutes should pay more attention to validation and verification after standard changes, strengthen the management of standard novelty search and standard conifrmation in order to exert the role of preventive measures, pay active attention to and keep track of the domestic and international important events in the ifeld of food and drug safety, focus on the international technical inspection standards for the defective products, provide support and preparation for the decision makers who plan expansion of new laboratory projects and allocate sufifcient resources, in order to truly meet the requirements of the public and the government supervision service.
出处
《中国药事》
CAS
2015年第4期369-373,共5页
Chinese Pharmaceutical Affairs
关键词
CNAS认可
标准查新
标准确认
检验机构
实验室管理
检测质量控制
CNAS accreditation
standard novelty search
standard conifrmation
inspection agency
laboratory management
detection quality control
