校准/测试实验室认可现场评审关键环节的技术分析

实验室认可是经授权的权威机构对具有校准(检定)和(或)测试任务的实验室能力的正式承认。实验室的现场评审是实验室认可的关键环节。文章介绍了校准/测试实验室认可进行现场评审的一般流程和考核方法,提出在现场评审前后实验室需要做的准备工作,指出实验室在接受现场评审应注意的几个问题,为所需要做认可工作的实验室加强能力建设和提高技术及管理水平提供帮助。     

实验室评审的类型

从评审目的划分,实验室评审可分为以下类型:1·初次评审:也称初评,实验室认可机构为确定首次申请认可的实验室是否符合规定的认可要求而进行的评审。2·监督评审:也称监督访问或监督,实验室认可机构为验证实验室在获得认可的有效期内是否持续符合规定的认可要求而安排的定期或不定期抽查评审。监督评审的程序与认可评审略有不同,每次监督评审除了部分必查内容,其余可选择检查,因此,现场监督评审总人日数可酌情减少。监督评审的技术能力范围仅限于实验室已获认可的能力,现场评审时,一般不扩大评审范围,但在认可有效期内的几次监督评审应覆盖…     

迎接CNAS现场评审实验室应如何进行技术能力的准备

所谓实验室认可,是对校准和检测实验室有能力进行指定类型的校准和检测所做的一种正式承认。从这个定义不难看出,实验室认可不完全等同于ISO9000的体系审查,它不仅要建立质量管理体系,而且要保证所申报项目的技术能力。在实验室认可评审中,不论是初次评审还是扩项评审或复评审,都要进行技术能力的核查,这是实验室认可现场评审的重点,因此也应该是实验室迎审准备工作中的重点。     

如何做好检测实验室的管理评审

本文从CNAS-CL01:2018《检测和校准实验室能力认可准则》(ISO/IEC 17025:2017)及《检验检测机构资质认定评审准则》(国认实[2016]33号)有关实验室管理评审的要求出发,结合自己的工作体会,介绍了实验室开展管理评审的步骤、如何才能做好实验室管理评审,并对CNAS-CL01《检测和校准实验室能力认可准则》2018版与2006版对管理评审的要求进行了差异比较,提高了对检测实验室开展管理评审活动的认识。     

盲样在实验室评审中的应用

0　前言众所周知 ,今天无论国际还是国内的有关实验室认可机构多以ＩＳＯ/ＩＥＣ170 2 5或ＧＢ/Ｔ15 481为依据评审认可实验室。按照导则ＩＳＯ/ＩＥＣ170 2 5进行实验室评审确实能够对被评审的实验室其组织机构、资源、管理和试验能力有一个基本定位。而对于实验室的试验能力则可通过对其软件和硬件的评审以及现场试验和比对实验给予核实。在实验室评审过程中 ,特别是现场评审利用盲样测试可以更直接地反映被评审的实验室仪器设备和技术素质的实际水平。由原中国实验室国家认可委员会制订的ＣＡ ＣＬ2 0 1- 7- 99《对电磁兼容检测领域认可…     

如何有效实施实验室管理评审

管理评审是实施质量管理体系的重要活动之一,无疑是不可或缺的。GB/T 27025-2008《检测和校准实验室能力的通用要求》的4.15条款中明确给出了实验室有关管理评审的规定。为此,笔者认为,实验室管理评审如何做到有效性值得深入探讨。     

实验室认可评审的特点

1·必须依据确定的认可准则对实验室进行评估。CNAS等同采用ISO/IEC17025∶2005《检测和校准实验室能力的通用要求》(CNAS/C101∶2006)作为实验室认可准则,对实验室的认可评审必须依据认可准则来进行。2·对于从事特殊领域的实验室,实验室评审依据除认可准则外,还包括认可准则在特殊检测领域的应用说明。此外,实验室建立的质量管理体系文件(质量手册、程序文件及作业指导书等)也是评审的依据。3·实验室评审的一项重要内容,是对其申请认可范围的检测和校准技术能力进行评价。实验室的技术能力反映在其所拥有的充分且适宜的检测设备、…     

中国计量科学研究院通过国家实验室认可复评审

9月9～11日，由中国实验室国家认可委员会组织的10位专家组成的评审组．对中国计量科学研究院实验室检测、校准能力进行复评审。此次复评审工作是计量院在1999年通过中国实验室国家认可委员会评审并获得认可以来．按照5年周期．对该院实验室能力进行的复评审。     

实验室认可和实验室评审有什么关系？

对于某个实验室的认可．意味着认可机构需要审查该实验室是否达到了认可机构关于实验室质量管理体系和技术能力方面的要求．是否能够提供满足一定准确度和可信度的检测报告或校准证书。实验室评审是实验室认可的基础．实验室评审为实验室认可提供依据。     

实验室的能力验证

实验室能力验证,是确定实验室检测能力,完善实验室内部质量控制,补充评审员和专家对实验室现场评审。增加实验室自身可信心。通过能力验证活动计划、组织和评价对实验室的测量结果给出满意或者不满意。     

Kalibrierung,Abnahme und Zertifizierung

Reliable information on the accuracy of a gauge or on the specification conformity of a component can only be gained by testing. In order to ensure that results of different testing laboratories have been obtained under equivalent conditions and thus are generally valid, standardized testing procedures and calibrated gauges have to be employed. Furthermore, competence and know-how is mandatory. Experienced testing laboratories can obtain an official accreditation, e.g., by the German calibration service DKD. The present article first gives a brief overview over important terms of calibration and acceptance specifications, and then describes the testing laboratory for measurands of vacuum technology at the Fachhochschule in Giessen.     

Interlaboratory proficiency testing: Intercomparison in relation to the measurement of alumina,iron(III) oxide and Titania present in homogenised china clay

For establishing technical competence in testing and calibration, a laboratory has to participate in proficiency testing (PT) program from time to time. An intercomparison in the field of chemical analysis using classical and instrumental methods of analysis has been carried out by 17 accredited as well as non accredited laboratories in India as per requirement of National Accreditation Board for Testing and Calibration Laboratories(NABL), New Delhi. Central Glass and Ceramic Research Institute(CGCRI), Kolkata acted as a nodal laboratory and conducted this PT programme during 2000–2001. This paper reports the analytical results and statistical evaluation of the results using Z-score.     

The inspection of drug metabolism and pharmacokinetic studies.

Areas in which the regulations apply must be discussed to ensure that an overall standard of "good practice" is applied to Absorption Distribution Metabolism Excretion (ADME) as an integral part of the safety testing program. There are specific problems in adapting the toxicology regulations for drug metabolism and pharmacokinetic studies. In reviewing the laboratories and their experimental procedures, an attempt to identify, through an auditing approach, how a drug metabolism laboratory can comply with regulations is presented. It must be regarded as of paramount importance that all work be carried out to the highest standards to allow the largest margin of safety. With these experiences, ADME Laboratories "new" to Good Laboratory Practice can proceed along the compliance pathway with minimum trauma to man, animal, and machine.     

Die Kalibrierung von Vakuummessgeräten in Industrie und Forschung

The increasing economic demand for higher measurement accuracy and the demands of modern quality assurance systems require regular calibration of the measuring and testing gauges. Vacuum gauges are more and more utilized as measuring and testing gauges in manufacturing processes and research in order to get reliable and correct product specifications. Systematic and statistical measuring deviations can only be determined through calibration. The reliability of test results is not only dependent on the accuracy, precision, repeatability and reproducibility but also depends on the competence of the tester and correctness of the testing method. Therefore, the confidence in the validity of the measurement results and in the competence of the calibration laboratory is a decisive factor. The calibration of vacuum gauges and the traceability to national standard is done through a series of comparison measurements. The calibration laboratories of the German calibration service (DKD), which are accredited by the Physikalische‐Technische Bundesanstalt (PTB), are distinguished by their technical expertise and high quality standard. The DKD‐calibration certificates offer reliable measurement results including the measuring uncertainty and are accepted by the accreditation bodies of the member states of the European co‐operation for Accreditation (EA). The typical requirements on a calibration laboratory for vacuum gauges are explained exemplarily for the DKD‐calibration laboratory of VACUUBRAND GMBH + CO KG company.     

Some supplier quality assurance assessment issues

An investigation has been carried out in thirteen suppliers of plant systems and equipment for one-off construction projects, to determine the benefits and problems of applying quality assurance. This paper reports the findings of the investigation. These suppliers and the major purchasing agents are confronted with special quality assurance problems such as multiple auditing and inspection which are allied to the one-off nature of the items supplied. It is pointed out that this sample of suppliers is commonly encountering four to five external audits each year and that there is some dissatisfaction with the professional competence of some auditors and many inspectors employed on non-nuclear contracts.     

国内检测实验室的现状与发展趋势

本文阐述了国际与国内第三方检测机构(实验室)现状,分析了当前国内第三方检测机构(实验室)存在的问题,提出了有针对性的解决方法,并对该行业的发展趋势做了合理的分析与指引,使国内第三方检测机构(实验室)更有目标性及更加规范化地健康发展。     

The INRIM Role of Inter-laboratory Comparison Provider for Electrical Power and Energy at Industrial Frequency: A Two-Year Activity Report

The technical surveillance of secondary calibration laboratories accredited according to the ISO/IEC 17025 standard for electrical power and energy at industrial frequency is very important, as these measurements are the basis of the commercial relations between an electricity supplier and a user. An effective technical surveillance requires the execution of inter-laboratory comparisons (ILCs). With them, it is possible to verify the competence of the laboratories and the correctness of the dissemination process from the national standards of power and energy, usually maintained at national metrology institutes, to these laboratories. The paper deals with the ILCs that the National Institute of Metrological Research (INRIM) provided and carried out as reference measurements provider for Italian accredited laboratories for power and energy (active and reactive) at industrial frequency. The ILCs were carried out involving various instrument types and at different uncertainty levels. The 2σ relative uncertainties of the INRIM calibrations ranged from 1.0?×?10^?4 to 1.5?×?10^?3. The ILCs had satisfactory results confirming the correctness of both the dissemination from INRIM and the accreditation process by the Italian accreditation body for calibration laboratories.     

校准领域能力验证发展现状及展望

阐述了我国校准领域开展能力验证的目的意义以及认可机构对实验室参加能力验证的要求,介绍了校准领域能力验证的现状,并对该领域能力验证未来发展进行了展望.     

Portable,highly stable,transistorized oscillator with several fixed frequencies

Summary The above highly-stable transistorized oscillator can be widely used in radio measuring laboratories, and especially in mobile laboratories, for testing equipment in situ. It can be assembled in other ways involving a smaller size and weight.     

一种天然橡胶硫化胶密度检测能力验证的统计分析

采用稳健统计技术对全国59家实验室橡胶密度能力验证结果进行统计分析,结果显示满意的为55家,结果可疑或离群的为4家。并对结果出现可疑或离群的原因进行了分析。