二级学院大型仪器管理探索与实践

各国家重点实验室及高校的校级公共测试中心的大型仪器管理已经发展的较为成熟,但是二级学院的大型仪器设备管理还有待加强.就二级学院大型仪器的科学管理进行了探索与实践,旨在提高其利用率和共享性,充分发挥大型仪器的使用效益.     

理化分析测试实验室仪器设备的管理

仪器设备是实验室的重要资产,仪器设备管理是实验室正常运行的重要组成部分。从仪器设备的管理架构以及仪器设备的采购、验收、量值溯源、维护维修、报废等方面讨论了理化分析测试实验室仪器设备管理工作的重点和注意事项。     

食品检测实验室大型检测设备的管理探讨

从食品实验室大型设备定义、仪器设备购置、使用管理、人员管理、共享管理、网络化管理、设备报废7个方面对食品检测实验室大型检测设备的管理进行了探讨,尤其是对量值传递/溯源、仪器使用人员管理提出了建议.     

辉光放电质谱仪期间核查控制图在实验室质量控制中的应用

仪器设备的期间核查是实验室管理及实验室认证认可的一项基本要求,辉光放电质谱仪主要应用于高纯金属材料的分析,标样研制较为困难,使用高纯标准物质进行质量控制及期间核查的方法难以实现。对用液氮低温冷却离子源型的辉光放电质谱仪,使用纯钽片在进行日常仪器调试信号时得到的钨元素含量数据,用于绘制平均值-极差控制图作为实验室质量控制及期间核查的判定依据,以此评价仪器日常工作的性能状态,以保证检测结果的正确性和可靠性。     

地方弱势高校实验室建设和管理改革的实践与探索

总结了地方弱势高校以实验室体制改革为切入点,以实施仪器设备动态管理、推行项目论证和实行贵重仪器设备中心化管理为重点的实践与探索,建立了较为完善的实验室管理体系,达到了全面提高实验室建设和管理水平的改革目标.     

基础化学实验室中小型仪器设备的三种管理模式

针对基础化学实验室中小型仪器设备种类多、数量多、品牌复杂、管理难度大的特点,提出了三种管理模式,即全程化管理、分类管理和互联网+辅助管理。近年的实验室管理实践表明,这三种管理模式的有机结合和融合应用,使中小型仪器设备的管理趋于科学、规范、高效,显著提高了仪器设备的使用率和完好率,从而保障了基础化学实验教学的顺利运行和教学质量的提高。     

理化实验室仪器设备的期间核查方法——以气相色谱仪的核查为实例

CNAS-CL01《检测和校准实验室能力认可准则》[1]及《实验室资质认定评审准则》[2]中要求实验室进行测量设备的期间核查。所谓"仪器设备期间核查"就是在两次正规的检定/校准间隔的期间,进行仪器的核查。其意义在于检查测量仪器的校准状态在校准有效期内是否得到保持,增加保持设备校准状态的可信度,防止使用不符合技术规范要求的仪器设备。通过期间核查及时发现出现的量值失准及缩短失准后的追溯时间,当核查发现不允许的偏     

仪器设备档案管理

介绍仪器设备档案包含的内容、产生的阶段及组卷编目的方法,对如何按照《检测和校准实验室能力的通用要求》(GB/T 15481-2000)做好仪器设备档案的标准化、规范化、科学化管理进行探讨。     

物理化学实验仪器的改革

南京大学化学化工学院“基础物理化学实验”的改革包括三方面的内容：　　（１）实验课程结构的变化。　　（２）实验内容的更新。　　（３）实验仪器设备自动化。　　物理化学基础课由于实验多,做实验的学生人数多,因此需要大量的仪器。由于经费的紧张和国内少有适合教学的仪器,严重妨碍该实验室的发展。十几年来,我们共同开发了许多对物理化学实验使用方便、自动化程度高而且价廉的专用仪器,大大改变了物化实验室的面貌,开发的许多仪器已经在全国各高校广泛使用。１　运用现代传感器技术建立无汞实验室　　化学实验室的汞污染一直是…     

扫描电子显微镜运行和管理的实践与探索

扫描电子显微镜常用于观察样品的内部结构以及化学组成,是材料学领域不可缺少的现代分析测试仪器. 绍兴文理学院使用扫描电子显微镜已十多年,年平均运行有效机时在1 000 h以上,是学校利用率最高的仪器设备之一. 结合大型仪器设备管理运行中的经验以及目前存在的一些问题,从检测技术提升、仪器共享、评价体系等方面对仪器的管理制度进行探讨.     

How instrument manufactures help with accreditation and ISO certification

 To help users of laboratory instrumentation to obtain laboratory accreditation and International Organization of Standardization certification, instrument manufactures should develop a comprehensive compliance programme for their products that includes product features, documentation and services for equipment validation and qualification. Received: 5 October 1998 · Accepted: 20 October 1998     

Quality management, certification and accreditation in medical laboratories – the view of ECLM

 Increasing demands from health care planners and industrialists conducting clinical trials, as well as general competition, are forcing medical laboratories to seek third-party recognition of their quality management systems. There is a tendency to move from certification of a laboratory director, via certification of the laboratory quality system (ISO 9000 family), to accreditation needing proof of professional and technical competence in laboratory tasks. The requirements of accreditation are presented in several national schemes and in the European Standards series (EN 45 000) and the International Organization for Standardization's guide, ISO/IEC 25, to be amalgamated soon. The latter system provides transnational recognition through participation of the accrediting bodies in the European co-operation for Accreditation. Necessary supplementary guidelines exist for chemical laboratories (Eurachem) and medical laboratories CEAC/ECLM). Traceability and reliability of results are obtained by utilizing a global reference examination system and by participating in transdisciplinary work. The costs of achieving accreditation are considerable and mainly involve the production of quality handbooks and written work procedures by personnel. The rewards are an open system, smoother work, emphasis on prevention of mistakes, and satisfied stakeholders. Received: 5 October 1998 · Accepted: 20 October 1998     

计算机在化学实验室自动化管理方面的应用

介绍了计算机技术在化学实验室自动化管理方面的应用动态,包括国内外在实验室信息自动化管理系统（LIMS）、实验室化学药品与材料管理系统（MIS）和实验室设备维护与校正管理系统（IMCS）的最新进展,以及上述计算机系统在实验室自动化管理方面的特点和作用。     

实验室认可的发展与体会

介绍实验室认可的发展过程与发展趋势。实验室认可的内涵是按章行事、全员参与、服务客户、实施预防、强化技术和不断完善。全面、灵活、文件资料多和要求严格是实验室认可的特点。组织落实、文件编制、人员培训、仪器档案整理、量值溯源、内审及管理评审是实施实验室认可的重要工作。     

Integrating accreditation, good laboratory practice and good manufacturing practice in an industrial analytical laboratory

 The Analytical Laboratory of BASF is a central service unit for chemical analysis which can be used by all departments within the company. It carries out routine as well as non-routine work and has a high amount of R&D orders. A quality system conforming with GMP rules was installed in the 1970s, followed by a GLP system about 6 years later. In 1995 an EN 45001 certificate was granted, which also stated the conformity with ISO 9002. A "types of test" orientated system was chosen for accreditation. This was better suited to the needs of a testing laboratory with a high amount of non-routine work than a purely test-procedure orientated accreditation. An integrated quality system has now been developed from these activities. It has partly common elements and partly differing elements taking into account specific regulations. For example, instrument calibration, staff training, validation of test procedures and the use of computerized systems are covered by uniform rules. Other elements such as handling of samples and report generation are arranged according to the individual requirements of the various standards. Rules and regulations are laid down in a system of documents which comprise the quality manual, general standard operating procedures (SOPs), laboratory-specific SOPs and test procedures. The quality system has been accepted by other accreditiation bodies on application of special accreditations (workplace safety, biodegradable polymers). But it has had no advantageous influence on getting GLP certification. An integrated system is very complex and requires appreciable resources. Management of processes and documentation can only be handled by extensive use of computers. Frequent training of staff and internal audits are necessary to keep the system at an acceptable level. In order to reduce the complexity of quality management regulations a harmonization of the different quality systems would be desirable. Received: 1 October 1998 · Accepted: 10 January 1999     

A combination of accreditation and certification in an evolving process at EMPA: A management system to meet ISO 9001, ISO 14001 and EN 45001

 The Swiss Federal Laboratories for Materials Testing and Research (EMPA) have established a quality assurance system based on EN 45001 which meets the requirements for accreditation of all EMPA's testing activities. As testing is only a part of EMPA's range of activities, and is performed in decentralised departments, the system does not satisfy the management needs. The fundamental reorganisation of EMPA's St. Gallen site was used as an opportunity to implement an overall process-oriented management system which also included quality and the needs for accreditation. Later, an environmental management system was added and then certified for ISO 9001 and 14001. The system consists of a "Management Manual" for the St. Gallen site and a customised "Quality Manual" for each department. One of the key elements is a comprehensive review and planning procedure covering all business aspects.     

冷冻双束扫描电镜的开放与管理

带冷冻传输系统的双束扫描电镜可实现样品原生态下的高分辨图像采集,以及冷冻含水样品的超薄切片制备,而被广泛应用于生命、医学、食品、化学、材料等领域,在相关科学研究中逐渐体现出不可取代的地位. 介绍了带冷冻系统扫描电镜的基本配置,并重点从开放共享与成效、仪器常见故障及维护等方面详细阐述了仪器的科学管理,以提高仪器的使用效率,为同类型仪器的运行提供管理经验.     

ISO 17025: practical benefits of implementing a quality system

As a laboratory certified to ISO 9001:2000 and accredited to ISO 17025, rtech laboratories has incorporated an overall system for technical and quality management, which results in benefits observed in daily laboratory practices. Technical requirements were updated to include the addition of formal personnel training plans and detailed records, method development and validation procedures, measurement of method uncertainty, and a defined equipment calibration and maintenance program. In addition, a stronger definition of the sample preparation process was documented to maintain consistency in sampling, and a more rigorous quality control monitoring program was implemented for chemistry and microbiology. Management quality improvements focused on document control to maintain consistent analytical processes, improved monitoring of supplier performance, a contract review process for documenting customer requirements, and a system for handling customer comments and complaints, with continuous improvement through corrective and preventive action procedures and audits. Quarterly management review of corrective actions, nonconforming testing, and proficiency testing aid in determining long-term trending. The practical benefits of these technical and management quality improvements are seen on a daily basis in the laboratory. Faster identification and resolution of issues regarding methods, personnel or equipment, improved customer satisfaction, meeting quality requirements of specialized customers, and overall increased laboratory business are all the result of implementing an effective quality system.     

The Slovak National Accreditation System

 After the split of the Czechoslovak Federation, the Slovak National Accreditation System was established in November 1993, being the only system in this country executing accreditation and certification. This system is strictly based on EN 45 000 and covers testing laboratories from both the mandatory and voluntary areas of metrological laboratories, products testing and certification, quality systems, and good laboratory practice. It seeks to reach the level of compatibility accepted and recognized by EU member countries. The development and basic features of the Slovak National Accreditation System, its basic principles, and the structure and competence of accreditation bodies are described in this article.