iso iec17025 2005 利用ISO/IEC17025积极促进实验室内部管理
ISO IEC17025 2005 uses ISO / IEC17025 actively promote the inner management of laboratories
ISO/IEC17025从组织、管理体系、评审、采购、服务、改进、审核等各方面对实验室的管理提出了指导性的要求,突出了实验室管理的适用性、公正性、安全性、回溯性、完整性、可控性等影响实验室检测效率和质量的核心要素。在这一管理体系下,传统的手工或半电子化(办公软件)的模式越来越难以满足实验室管理的要求。好的LIMS除了能够帮助解决实验室的信息管理问题,在维护实验室的认证地位上也将扮演重要的角色。
ISO / IEC17025 from the organization, management system, assessment, procurement, services, improvement, the audit of the laboratory management guidance put forward requirements, highlight the laboratory management application, fairness, security, retrospective, integrity, controllability and other effects of laboratory detection efficiency and the quality of the core elements. In this system, the traditional manual or semi-automatic electronic ( office software ) model is more and more difficult to meet the requirements of the laboratory management. A good LIMS can help to solve the problems of information management in the laboratory, laboratory certification status also will play an important role.
1、适用性
In 1, the applicability of
适用性指的是实验室的管理体系应覆盖实验室在固定设施内、离开其固定设施的场所,或在相关的临时或移动设施中进行的工作。从LIMS的角度来看,这是一个首先要考虑的系统适用范围的问题。
Applicability refers to the laboratory management system should cover the laboratory at permanent facilities, leaving the facility fixed places, or in a related temporary or mobile facilities for work. From a LIMS perspective, this is a must consider the application range of the system problems.
一个好的LIMS设计,应该将实验室业务所涉及的所有活动和信息都纳入其管理范畴,以分析测试业务流程为核心,将人员、试剂、实验方法、实验环境、标准等影响分析数据的因素有机地结合起来,建立开放标准的实验室管理平台,为实验室提供全方位的业务流程管理服务,包括样品受理、检测与分析流程控制、检测结果验证与分析、仪器检测数据自动化采集、仪器设备监控、标准样品和实验耗材管理、实验室知识与标准管理、实验室供应链管理、第三方实验室客户关系管理、报表处理和历史数据挖掘与分析、实验室相关机构接口集成等,以帮助实验室全面管理和控制影响质量的核心要素和流程。
A good LIMS design, should the lab business involved in all activities and information into their management category, to analysis and testing business process as the core, the personnel, reagents, experimental methods, experimental environment, standard data element analysis of effect of organic ground union rises, build open standard laboratory management platform, for the the laboratory offers a full range of business process management services, including the sample receiving, process control, detection and analysis of test results, test and analysis instrument for the detection of automatic data collection, equipment monitoring, standard samples and laboratory supplies, laboratory management, laboratory knowledge and standard management of supply chain management, customer relationship management, third party laboratory report processing and historical data mining and analysis of laboratory related institutions, interface integration, to aid the laboratory comprehensive management and control of affecting the quality of the core element and process.
2、公正性
2, fairness
公正性是指实验室及其员工不受任何可能影响其技术判断的、不正当的商业、财务或其他方面的压力,第三方检测或校准实验室不应当参与任何可能损害其判断独立性和检测或校准诚信度的活动。
Justice refers to the laboratory and its staff from any possible influence their technical judgement, unfair business, financial or other pressures, the third party testing or calibration laboratory should not participate in any possible damage to the independence of judgement and integrity of the test or calibration activities.
实验室作为一个独立的检测机构,为保证其公正性,检测活动中所产生的任何信息都应当有完整的记录,包括样品登录信息、样品测试需求、测试标准、客户信息、仪器信息、检测人员信息、收费标准、测试数据、结果分析与验证、测试报告等等。因此,好的LIMS应当以流程为核心,将这些信息串联起来,并对测试过程中发生的所有活动以事件、日志、数据记录、审核记录、变更记录的形式归档。对实验室管理来讲,这一方面是保证公正性的措施,另一方面也是对实验室的一种法律保护手段。
Laboratory as an independent testing agency, in order to ensure the impartiality, testing activities arising out of any information should have complete records, including sample login information, sample test requirement, test standard, customer information, equipment information, testing personnel information, standards, test data, the results of analysis and test, test report and so on. Therefore, a good LIMS should take process as the core, the information together, and the test process occurring in all events to event, log, data record, audit records, change records in the form of filing. The laboratory management is concerned, on the one hand is to ensure fairness measures, but also to the laboratory as a means of legal protection.
iso iec17025 2005 利用ISO/IEC17025积极促进实验室内部管理
发布时间: 2011-12-23 01:48 点击:
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