环境监测实验室内部质量审核之我见

根据漯河市环境监测站实验室内部质量审核的工作体会,分析了环境监测实验室开展内部质量审核的意义,着重探讨了如何开展质量体系内部审核工作.     

流程图在实验室质量管理中的应用

通过文件控制程序的制定、合同评审程序的制定、内部审核过程的策划等,详细介绍了流程图在实验室质量管理工作中的应用。     

天然气检测实验室质量控制方式探讨

结合天然气检测工作实际情况,对天然气检测实验室质量控制方式进行了探讨。检测实验室质量控制分为内部质量控制和外部质量控制。检测实验室内部质量控制方式有重复检测、内部比对、使用有证标准物质、检测方法中规定的内部质量控制、不确定度评定及校准曲线等;外部质量控制方式有实验室间比对和测量审核两种方式。当评价精密度控制时,可使用重复检测、内部比对、检测方法中规定的内部质量控制等方式;当评价准确度时,可使用有证标准物质;当需对检测全过程进行评价时,可采用不确定度评定、校准曲线、实验室间比对、测量审核等方式。     

内部审核在计量体系中的作用

介绍内部审核制度在计量测试工作中的目的和作用，提出了内部审核工作应注意的事项，如内部审核工作计划的完整性，内部审核工作的有效性，管理者工作内容的全面性，以及后续工作的完善性。     

检测实验室如何开展质量体系内部审核工作

详细论述了审核的基本概念、开展质量体系内部审核工作的必要性、如何开展质量体系内部审核工作以及中国实验室国家认可委员会的有关政策。     

浅谈实验室内审工作的几点体会

检测实验室建立了质量管理体系,并依据该体系有序运行。在这个过程中,需要有一个自我发现问题、自我纠正并事前预防的机制,以验证管理体系运行的符合性,这个机制就是管理体系的内部审核(简称"内审")。内审工作的水平体现了实验室内部管理的能力。作为一种内部管理机制,内审对实验室日常运作的顺利进行及质量安全的保证具有不可估量的作用。因此如何做好内审工作,提高内审工作的质量就显得非常重要。本文结合实验室内审工     

水杨酸片溶出度测定测量审核结果分析与常见问题探讨

通过对2015—2020年开展的水杨酸片溶出度测定测量审核工作的回顾和梳理,阐述了水杨酸片溶出度测量审核工作的实施模式,分析了可能影响溶出度测定结果的因素,并就参与实验室存在的问题和相关的改进措施进行了探讨。水杨酸片溶出度测定测量审核是相关实验室提升溶出度测定检测能力的一种有效方法,在加强组织方质量管理体系的改进和建设方面也有积极的促进作用。     

协同评定试验在测量审核结果评价中的适用性

<正>测量审核是"一个参加者对被测物品(材料或制品)进行实际测试,其测试结果与参考值进行比较的活动",是对一个参加者进行"一对一"能力评价的能力验证计划~([1])。测量审核以其及时、高效和覆盖范围广的独特优势,逐渐成为实验室获得能力验证的重要途径~([2])。随着实验室认证、认可的快速发展,测量审核的需求逐年增加,广泛的样品种类及结果评价方式可以促进测量审核更好的发展。协同研究试验是实验室间进行的试验研究,这     

北京中实国金国际实验室能力验证研究有限公司

<正>北京中实国金国际实验室能力验证研究有限公司成立于2002年,是专业从事国际实验室能力验证、测量审核服务的研究中心。中实国金于2004年1月首次通过中国合格评定国家认可委员会的认可(No.CNAS PT0002),是国内具有能力验证提供者资格的第三方独立法人机构。     

氧氮氢气体分析项目NADCAP认证的技术要点

通过解析氧氮氢气体分析项目进行NADCAP认证所依据的相关标准及审核文件,并结合实验室实际认证工作经验,总结了该项目进行认证时在作业指导书、人员、设备、标准物质、能力矩阵及校准方式等几个方面的技术要点,并提出相应建议,为首次申请该试验项目NADCAP认证的实验室提供参考。     

Internal audits in private medical laboratory practice – a Finnish experience in 1996–2000

Internal audits inherently effect quality improvement, and concrete results can be expected by careful planning. As audits should improve the quality system in situ, the development of audits should not be neglected. ISO/IEC 17025 describes the objectives of internal audits and management reviews in more detail compared to the former standards EN 45001 and ISO/IEC Guide 25, although the main features are unchanged. This addresses continuous surveillance of the current practice. A brief questionnaire on vertical audits was distributed to 74 of 120 employees at a Finnish private medical laboratory, Medix Laboratories Ltd. A positive feed-back was received from the current management of audits. However, the study revealed that continuous supervision of audits is needed. Many employees were not willing to perform audits if they had no previous experience. Additionally, audits performed at the workbench were not considered as the best possible for fruitful discussions. Received: 20 February 2001 Accepted: 30 November 2001     

Statistical analysis of findings in external and internal audits and assessments in a testing laboratory

A statistical analysis of findings in assessments by an accreditation body, external audits and internal audits in an accredited testing laboratory for gamma-ray spectrometry is presented. The frequencies of observations reported in different areas were examined and analysed. The differences are interpreted in terms of the varying importance associated with the different areas as perceived by auditors and assessors.     

Communication: the essential factor when implementing management systems

Internal communication within a company is essential for the implementation and proper functioning of any ISO-based quality system. Moreover, staff empowerment and distribution of responsibilities are key points in the ISO 9000:2000 quality guides. Although not specifically mentioned in the quality guides, external communication plays a fundamental role in assuring customer satisfaction and obtaining good ideas to improve company performance. This paper has two main parts. First, the importance of internal and external communication is reviewed and it is shown that managers should allocate more resources to both areas. It is also demonstrated that environmental management systems are directly derived from the quality guides. Second, the results of an enquiry to assess the efforts being made by a group of Italian senior managers to improve internal and external communication are evaluated. Received: 8 March 2002 Accepted: 12 September 2002     

Accreditation of small laboratories

 This paper presents the result of an investigation concerning which areas of EN 45001 are considered as especially problematic by small laboratories (<10 employees). The investigation was performed by distributing questionnaires to European laboratories. To be able to differentiate between areas considered as problematic only by small laboratories and areas considered as problematic by laboratories in general, some questionnaires sent in by larger (>10 employees) laboratories were used. The determination of measurement uncertainties within reasonable efforts and the requirements to take part in round robin and proficiency testing were considered problematic by laboratories of all sizes. Training is an area where small laboratories have specific problems and so are the requirements for the identification of all equipment. Other problematic areas for small laboratories are areas were there are needs for personnel, e.g. appointing supervising personnel and expenditure for internal audits. The last area to be considered as problematic is matters concerning documentation. Finally some advice concerning assessment of small laboratories is given. Received: 25 February 2000 / Accepted: 20 April 2000     

Implementation of ISO 9002 for research in occupational epidemiology

 The Department of Epidemiology, which forms part of the French National Institute for Research and Safety (INRS), is involved in research on occupational risks. It provides results of industry-based epidemiological studies focused on the relationship between occupational exposure and diseases of the respiratory system, central and peripheral nervous systems and cancer. This paper describes the Quality Assurance System developed by our department, which has been successfully maintained and extended since being granted ISO 9002 certification by the French Association for Quality Assurance. The quality system includes procedures specific to epidemiological study conduct and scientific peer reviews. It has been designed in order to meet the required ISO elements, including quality aims and policy, quality procedures for management of personnel, sub-contractors and facilities, nonconformities, corrective and preventive actions, archiving and traceability and planning of internal quality audits. Improvements in management, technical and service quality have resulted from this process. Although epidemiological studies differ markedly from industrial production for which the standards were originally drawn up, we have found that Quality Assurance is both applicable and useful in epidemiological research on occupational risks. Therefore, we conclude that a certified Quality Assurance Scheme including scientific peer reviews can be recommended to ensure reliable epidemiological results. Received: 22 July 1998 · Accepted: 5 October 1998     

Analytical instrument maintenance and its implications

The various aspects of importance for the maintenance of analytical instruments for process control are discussed. This discussion is based on practical experience in a large industrial chemical company. Emphasis is placed on the organizational aspects and the continuous attention that is needed. Also, the significant role of audits is stressed.     

From quality inspection to quality assurance

Summary Systematic quality assurance, e.g. in accordance with the provisions of ISO 9000, requires not only the targeted use of quality as a management tool, but also a revised attitude to operational procedures. Although sophisticated checking of the final results of a procedure (e.g. results of analyses, sales products, reports) meets the legal requirements and often also the customers' requirements, this misses the chance of being able to influence the quality of a final result at the earliest possible stage. It is then only possible subsequently to take the uneconomic decision as to whether the result of the work is useable or must be discarded or the object reworked. Within quality assurance, all operations are to be considered as processes with the aim of arriving at a statistically controlled process. The advantages of statistical process control are explained by way of examples from analytical procedures and production. The status of internal audits is explained as it interrelates with process control.     

Field evaluations of the VDmax approach for substantiation of a 25 kGy sterilization dose and its application to other preselected doses

The International and European standards for radiation sterilization require evidence of the effectiveness of a minimum sterilization dose of 25 kGy but do not provide detailed guidance on how this evidence can be generated. An approach, designated VD_max, has recently been described and computer evaluated to provide safe and unambiguous substantiation of a 25 kGy sterilization dose. The approach has been further developed into a practical method, which has been subjected to field evaluations at three manufacturing facilities which produce different types of medical devices. The three facilities each used a different overall evaluation strategy: Facility A used VD_max for quarterly dose audits; Facility B compared VD_max and Method 1 in side-by-side parallel experiments; and Facility C, a new facility at start-up, used VD_max for initial substantiation of 25 kGy and subsequent quarterly dose audits. A common element at all three facilities was the use of 10 product units for irradiation in the verification dose experiment.

The field evaluations of the VD_max method were successful at all three facilities; they included many different types of medical devices/product families with a wide range of average bioburden and sample item portion values used in the verification dose experiments. Overall, around 500 verification dose experiments were performed and no failures were observed. In the side-by-side parallel experiments, the outcomes of the VD_max experiments were consistent with the outcomes observed with Method 1.

The VD_max approach has been extended to sterilization doses >25 and <25 kGy; verification doses have been derived for sterilization doses of 15, 20, 30, and 35 kGy. Widespread application of the VD_max method for doses other than 25 kGy must await controlled field evaluations and the development of appropriate specifications/standards.