浅谈实验室质量体系的自我评价

随着实验室认可工作的深入开展，不少实验室都按照ISO／IEC17025：1999的要求建立了质量体系，并通过对不符合项的控制、采取纠正和预防措施以及开展质量体系审核、管理评审工作对质量体系进行持续改进，不断提高质量体系的运行质量。但是，在质量体系管理过程中，对质量体系运行质量的     

核岛机电安装施工质量体系文件建立的方法与实践

本文结合田湾核电站核岛机电安装工程总结了施工质量体系文件的建立、管理以及具体实践经验,可为同类工程施工质量体系文件的建立与管理提供参考.     

如何编制程序文件和作业指导书

组织(机构)建立质量体系是基础,而实施质量体系,维持质量体系,改进质量体系是关键,有计划地监控质量体系,有效地审核和评审质量体系是保障.如何建立质量体系及编制质量体系文件,虽然没有什么"准则"、"规范"来强制某种模式,但也有"指南"来作某些指导和建议,如GB/T19023-1996(idtiSO10013:1995)<质量手册编制指南>及2001年ISO颁布的技术报告:ISO/TR10013<质量管理体系文件指南>.该指南较为详细地描述了质量手册、程序文件、作业指导书、表格及质量计划等质量管理体系文件的编制建议.     

控制原理在实验室质量管理中的应用

本文结合实验室质量体系实践经验,从管理学的基本职能之一———“控制”来阐述体系受控的意义,探讨如何建立一套有效的实验室体系日常管理控制系统。本文对检测实验室建立有效的质量体系、评估质量体系的有效性具有借鉴意义。     

试析房地产开发企业质量保证框架及主要质量体系要素（续）

三、房地产开发企业的主要质量体系要素及其内容: 房地产开发企业的经营活动从一开始到最终的过程都是开放式的,因此在房地产企业中建立质量体系时,选取的要素应当考虑到内外部的相互作用和依赖,抓住主要要素建立体系框架。我们认为,房地产开发企业的主要质量体系要素     

控制原理在实验室质量管理中的应用

本文结合实验室质量体系实践经验，从管理学的基本职能之一——“控制”来阐述体系受控的意义，探讨如何建立一套有效的实验室体系日常管理控制系统。本文对检测实验室建立有效的质量体系、评估质量体系的有效性具有借鉴意义。     

新时期军工质量管理体系建设

本文从现行质量管理体系存在的一些不足、质量体系的策划与实施、质量体系的审核和评价、持续改进质量管理体系和全面提升质量管理体系的有效性等方面,对如何建立、实施和保持新时期质量管理体系提出了建议和做法。     

如何做好质量认证中的测量设备管理

文章阐述了计量工作在质量体系中的重要地位，测量设备管理是计量检测体系的主要环节，探讨了在建立质量体系过程中，如何加强测量设备管理工作，分析了GB／T19000族标准中，对测量设备质量的控制要求和所需的控制范围。     

服务业质量体系必须以顾客为核心

ISO9004-2第五部分,一开头就指出了服务业建立质量体系的关键,并用一个“三角四圈”图来加以说明(见下图)。文中指出:“图中表示出顾客是质量体系三个关键方面的焦点,还表示,只有当管理者职责、人员和物质资源以及质量体系结构三者相互协调时,才能保证顾客满意。”这段话是ISO9004-2的关键,它道出了服务业建立质量体系和工业企业之间的最主要的区别。     

如何有效完成实验室质量体系文件编制工作

目前，国际上通行的实验室认可准则就是ISO／IFC17025：1999《测试和校准实验室能力的通用要求》。申请认可的实验室根据此标准建立的质量体系，是文件化的管理体系。实验室须把该标准中所包含的质量管理要素和技术要素融入到本实验室的实际系统工作中，编制质量体系文件，以指导本实验室的工作，确保一切活动有章可循，有据可查。可见，编制好各级质量体系文件是建立、运行质量体系的关键。     

Metrological Assurance as a Base for Building a Quality System

We consider the role of metrological assurance of quality systems in the initial stage of development, based on the ISO 9000 standards. Most of the quality system elements must be developed with account for the requirements of the standardizing documents for metrological assurance of production. The body of actual standardizing documents of the state measurement traceability system given is expedient for use when developing company quality systems.     

Quality assurance systems for individual monitoring services

The International Basic Safety Standards for Protection Against Ionizing Radiation and for the Safety of Radiation Sources (BSS) require, inter alia, the establishment and implementation of quality assurance programmes to ensure that protection and safety requirements are met. The findings and conclusions of the International Conference on Topical Issues in Nuclear and Radiation Safety held in Vienna in 1998 includes, among others, the following recommendation concerning occupational radiation protection: The BSS require a quality assurance (QA) programme to be established as part of radiological protection. Extensive guidance for the development of a QA system is given in reports of ISO and IEC, but further guidance is needed on the interpretation and implementation of these standards. This paper is focused on the available international standards on quality assurance and on the work the IAEA is currently carrying out for their implementation in radiation monitoring services.     

Quality assurance in pharmaceutical powder processing: Current developments

Abstract

Pharmacopoeia1 requirements relating to standardization of the physical performance of oral dosage forms containing powders are usually limited to tests on the final product.

Such tests are aimed at ensuring that all tablets or capsules have the correct, nominal, drug content and that the drug is released into solution within a specified time. Whilst dissolution or disintegration test to assess drug release can only be carried out on a finished dosage form, content uniformity tests currently carried out on tablets or capsules alone could also be usefully carried out earlier on component powders at different stages during processing. The aim of developing a quality assurance procedure for quantifying the homogeneity of powders prior to tablet compaction or encapsulation would be to pin-point more precisely the part of a process where content uniformity problems arise. Secondly, a good quality assurance procedure would provide full mechanistic information about the behaviour of a given powder system, so that appropriate remedies could be applied.

Eleven different methods of testing homogeneity of powder mixes have been cited in pharmaceutically oriented literature and these will be reviewed in terms of their usefulness as routine quality assurance procedures for drug content uniformity. Of these 11 methods, 2 test methods were considered to be especially useful: one based on a flow test and the other on vibration analysis. This techniques has been validated using a complete vibration analysis and testing rig under conditions encountered during routine powder processing.

It would be desirable to see standard powder mixes tested on apparatus of the same design in different laboratories as a means of assessing the reproducibility of the proposed quality assurance method when used by different personnel.     

Mapping quality assurance systems: A methodology

This paper reports on a method (quality management activity planning—Q-MAP) for mapping quality assurance procedures, information flows and responsibilities. A comparison is made of the ICAM definition (IDEF) method and Q-MAP as to their suitability for mapping quality assurance systems and fostering the advancement of the quality improvement process. The achievements arising from the use of Q-MAP at Garrett Automotive Limited are examined. It is pointed out that the involvement of employees in the preparation of Q-MAP diagrams has led to improvements in processes and procedures by eliminating differences between actual and documented work practices and that a wider cross-section of employees are now familiar with the company's quality assurance system.     

Development of a quality assurance programme for external personal dosimetry in Slovenia

In order to improve the quality of individual monitoring and to achieve harmonisation with the new international standards, important components of a quality assurance system are considered and are presented as a result of cooperation of different institutions. The components are quality assurance and routine quality control of monitoring systems, and the creation of a central state dose register of workers.     

Quality management systems for higher education?

Quality, its assurance, management and assessment, has become a topical issue in higher education. This paper outlines some of the issues involved in setting up quality management systems in an educational environment. In discussion of quality audit and assessment in higher education is followed by a brief review of current approaches to quality management in industry. The Engineering Professors' Conference (EPC) approach to quality assurance in higher education is introduced, to provide a conceptual framework for quality system development. A case study of the implementation of a quality system in one university engineering department is provided. Finally some practical conclusions are drawn, which should help a department set up its own quality system     

Subjective and objective measures of image quality in digital fluoroscopy

There are numerous methods for assessing image quality in diagnostic X ray. In our study we assessed how imaging quality assurance methods perform in practice. Physics assessments were based on IPEM protocols using Leeds test objects. Clinical assessment was based on a questionnaire. A total of 15 systems in three European locations were assessed, covering a range of image intensifier-TV digital fluoroscopy units. Analysis of 274 clinical questionnaires showed that clinical and physics assessments did not place systems in the same order, based on a given image quality parameter. In almost all the comparisons, low level correlation was measured for statistical comparison of rank order (rs < 0.3). However, broad agreement was observed between physics and clinical assessments for image quality associated with contrast and noise. This study emphasises the importance of maintaining links with clinical assessment, when developing quality assurance metrics, and measuring the mutual performance of clinical and physical assessments of image quality.     

面向重组的质量保证计划建模环境

本文提出了解决了质量计划建模工具的关键技术。讨论了敏捷企业根据质量保证计划快速重组的方法和工作流技术在质量保证系统中的应用,并对质量计划建模工具如何根据质量管理流程的设计和实现特点做了阐述。     

日本农产品质量安全保障体系

本文分析了日本农产品质量安全保障体系,包括监管、法律法规、质量标准、认证.为了解日本农产品质量保障体系提供参考     

研究反应堆安全运行管理的策略

描述安全管理策略中安全化、纵深防御、质量保证的特点,简要介绍研究反应堆安全运行管理的任务分配和管理体系,指出研究反应堆的安全运行管理应注重研究“安全化-纵深防御-质量保证”的交互作用并遵守安全、可靠、高效和经济性的管理要求。