化学检测实验室认可中涉及的检测方法、样品及结果报告

正CNAS-CL01-A002:2020《检测和校准实验室能力认可准则在化学检测领域的应用说明》(简称A002:2020)于2021年1月1日实施,2021年7月1日以后,所有受理、评审业务均应按新版文件执行。在过渡期内,由于化学检测的多样性和相对不确定性,实验室在按照CNAS-CL01-A002:2018《检测和校准实验室能力认可准则》及其化学应用说明老版文件A002:2018的要求进行实际运行时,容易忽略A002:2020中的一些关键点,如检测方法、     

法定计量检定机构计量授权与实验室认可管理体系文件整合的探讨

阐述法定计量检定机构计量授权与CNAS实验室认可的区别,对考核依据的文件JJF 1069–2012与CNAS–CL01:2006进行了分析比较,编制了条款对照表,并对管理体系文件兼容整合的方式及实施方法进行了探讨。由于两种考核依据的标准规范除个别要求外其它基本相同,故可按照任意一个考核规范的要求进行修订,兼容整合另一个管理体系,但要体现计量法制、过程管理等方面的要求。在实施管理体系文件整合时,应首先从质量手册开始,依次开展程序文件及其它文件的整合。     

化学检测实验室认可中的资源要求分析

<正>CNAS-CL01:2018《检测和校准实验室能力认可准则(ISO/IEC17025:2017)(以下简称CNAS-CL01:2018)于2018年3月1日发布。CNAS-CL 01-A002:2020《检测和校准实验室能力认可准则在化学检测领域的应用说明》(以下简称A002:2020)于2021年1月1日实施,2021年7月1日以后所有受理、评审均执行A002:2020。两个文件与其前一版相比,除了内容进行了调整外,结构也有较大变化,     

实验室间比对在确保结果有效性中的应用

<正>实验室间比对是指按照预先规定的条件,由两个或多个实验室对同一或相似物品进行测量或检测的组织、实施和评价。实验室间比对和能力验证是确保检测结果准确可靠的重要手段,并且可以发现与其他实验室间的差距。申请认可、资质认定或已获认可、资质认定的检验检测机构应尽可能参加实验室间的比对试验和能力验证活动。中国合格评定国家认可委员会(CNAS)在2018年发布的CNAS-CL01:2018《检测和校准实验室能力认可准则》[1]中要求,     

实验室认可基础、评审方法与发展趋势

从什么是实验室认可和中国实验室国家认可委员会、实验室评审认可依据和基本要求、实验室认可过程、现场评审技巧和国内外发展趋势五个方面对实验室认可作了介绍,可为我国实验室逐步实现与国际接轨的规范化管理提供借鉴。     

2018版实验室认可准则对设备管理的要求及应对措施

根据CNAS–CL01:2018实验室认可准则要求建立设备管理新方法。CNAS–CL01:2018实验室认可准则新增设备范畴、校准范围、校准方案要求和固定型号记录4项内容,涉及设备验证、检测设备要求、期间核查3方面5项管理内容的变动。从文件修订和应用改进提出设备管理需采取的措施,为CNAS–CL01:2018版实验室认可准则的顺利实施提供保障。     

Bootstrap方法在能力验证统计分析中的应用北大核心CSCD

由于经济全球化和高科技迅猛发展的需要,我国许多实验室已通过了中国合格评定国家认可委员会（CNAS）的认可,还有许多实验室正在准备认可。在实验室认可活动中利用实验室间比对的能力验证活动是一项非常重要的内容,它受到国际实验室认可合作组织及世界各国实验室认可组织的高度重视。能力验证是利用实验室间的比对来判定实验室和检查机构能力的活动[1-2],     

Bootstrap方法在能力验证统计分析中的应用

<正>由于经济全球化和高科技迅猛发展的需要,我国许多实验室已通过了中国合格评定国家认可委员会(CNAS)的认可,还有许多实验室正在准备认可。在实验室认可活动中利用实验室间比对的能力验证活动是一项非常重要的内容,它受到国际实验室认可合作组织及世界各国实验室认可组织的高度重视。能力验证是利用实验室间的比对来判定实验室和检查机构能力的活动[1-2],也是认可机构加入和维     

测试分析实验室认可

测试分析实验室的测试报告是否准确可靠及能否为各有关方面一致承认,是用户最为关心和迫切需要解决的问题。为此,许多工业化国家建立了测试分析实验室认可制度。各国的测试分析实验室认可制度虽不相同,但在原则上都有共同之处。它们都是由一定的实验室认可机构制订方案,经过评价审查予以认可并发给证书。测试分析实验室认可并不     

实验室管理系统结合短信平台在食品检测标准物质管理中的应用

食品检测实验室大量使用标准物质,而根据实验室认可及资质认定等文件规定,标准物质在使用管理上需要完备的记录链,数量众多的标准物质使实验室标准物质管理增加了难度。利用实验室管理系统与短信平台相结合的技术管理标准物质,构建标准物质采购、入库、验收、保存、使用等信息管理系统,使标准物质管理中物流与信息流保持同步,提高了实验室标准物质管理水平。     

Comparative analysis of laboratory accreditation in Bulgaria, Lithuania, Slovakia and Serbia and Montenegro

The development of an internationally recognized laboratory accreditation process, accompanied by a mutual recognition agreement (MRA), is an issue of great interest in Central and Eastern European countries. This paper presents a comparative analysis of laboratory accreditation in Bulgaria, Lithuania, Slovakia and Serbia and Montenegro. The basic analysis technique was preliminary laboratory accreditation assessment (PLAA). The analysis data were obtained via a questionnaire issued from January to June 2004, with the participation of accreditation bodies. Results from the study are presented in four sections: accreditation body standards, accreditation body organization, assessors and proficiency testing, and inter-laboratory comparisons. Research results for the countries were accessed using PLAA techniques and conformity/non conformity statements. The analysis verified that PLAA can provide low cost, rapid assessment of the key influencing factors in laboratory accreditation bodies.     

Laboratory authorization versus accreditation in transitional economies: case study of Serbia

Many CEE governments are still using various systems of laboratory authorization together with ISO/IEC 17025 laboratory accreditation. It is difficult to understand from the EU prospective, the existence of two parallel laboratory competence verification systems. The basic relations between laboratory accreditation and authorization: independence and succession have been defined. The case study of testing laboratory accreditation versus authorization in Serbia, has been presented and discussed. Relevant requests and procedures for water quality, food and air quality testing laboratory authorization were analysed in detail. Comparative analyses of accreditation and authorization have established: (i) independent relations, (ii) relevant regulation is in collision and barely legal, (iii) authorization is (technically) on the far lower level than accreditation is, and (iv) authorization requests cause high space and personnel costs. It has been concluded that it is not adequate to perform two policies at the same time: one EU oriented—laboratory accreditation, and one non-EU oriented—laboratory authorization. The policy proposal is that all CEE countries should abandon existing laboratory authorization procedures and replace them by accreditation. Proposed goal could be reached in rather a short transition process of 2–3 years.     

NATA: 50 years experience with accreditation

 Laboratory accreditation is becoming increasingly accepted around the world as a means of identifying technically competent laboratories. It is also being used as a mechanism for the acceptance of test data both nationally and internationally. The concept and mechanisms of accreditation have been developed over the past 50 years. The first national laboratory accreditation system appeared in Australia in 1947. This organisation, known as the National Association of Testing Authorities (NATA), has since taken a leading role in developing accreditation practices that are now used world-wide in evaluating testing, measurement and calibration laboratories. This paper examines the development of the world's first and largest laboratory accreditation system, and looks at the difficulties and triumphs in gaining acceptance and recognition by government and industry of the benefits of laboratory accreditation. Received: 24 June 1996 Accepted: 25 June 1996     

Accreditation in analytical laboratories: a critical assessment of its impact on human beings and techniques

Summary The relationships between Quality, Quality Assurance and Third Party Approval by accreditation based on formal application of EN 29002, EN 45001 and ISO Guide 25 are briefly outlined for analytical chemical laboratories working in the non-regulated area. The roles of human beings in laboratories and accreditation bodies are discussed and recommendations are made on how to minimize friction during accreditation processes. The structures of the European Accreditation Systems are reviewed and the efforts towards mutual recognition of the national accreditation bodies are described and critically assessed. The lack of competition based on free market conditions in the framework of company law is deplored. The assessment of laboratory systems, rather than assessing the activity of laboratories against technical standards, is recommended (unless it is otherwise requested). The beneficial effects of the process of accreditation on competence and quality of the activity of the laboratory are emphasized.     

实验室的认可和质量管理体系的建立与运行

简要介绍了实验室认可的发展情况，开展实验室认可的必要性，实验室的质量管理体系的建立、运行及认证认可。     

Accreditation: a challenge

 This paper describes a real accreditation case from VTT Chemical Technology in Finland. The laboratory has acquired accreditation according to ISO/IEC Guide 25 and EN 45001 for a variety of organic and inorganic environmental tests. The present paper summarizes the reasons for applying for accreditation and selecting the test methods, gives the costs involved, and describes some future developments and views. Also, some details of laboratory intercomparisons and quality system structures are briefly reported.     

Can single-operator laboratories comply with all of the requirements of ISO/IEC 17025:2005?

ISO/IEC 17025:2005 states that its requirements are “applicable to all laboratories regardless of the number of personnel” and would therefore include single-operator laboratories. However, there are reservations as to whether these laboratories can comply with all of the requirements without jeopardizing independence of judgement and impartiality. Similarly, there are some requirements of ISO/IEC 17025:2005 including staff supervision, internal communication processes and appointment of deputies that are considered unlikely to apply to a single-operator laboratory. The ISO/IEC 17025:2005 is widely used as the international standard of quality assurance by which accreditation bodies assess the competency of testing and calibration laboratories. There does, however, appear to exist, disagreement amongst accreditation experts when considering single-operator laboratories. Some accreditation bodies accredit single-operator laboratories, whilst others require additional human resources prior to granting accreditation. This discrepancy leads to unfair competition amongst laboratories as a single-operator laboratory by definition needs less resources (both human and financial) to achieve and maintain accreditation, compared with a laboratory where additional human resources need to be sought prior to and in order to maintain accreditation. The ISO/IEC 17025:2005 is in the process of being revised, and this is an opportune moment to address the issues aforementioned with the aim of removing ambiguity and enhancing clarity. In addition, the hope is to assist the accreditation bodies themselves to adopt a consensus approach when granting accreditation towards single-operator laboratories.     

Accreditation of types of tests

 DACH, the German accreditation body of chemistry, which was founded in 1992, has introduced a new model for the flexibilization of the scope of accreditation. This ensures that the accreditation of a laboratory also guarantees flexibility. Flexibilization of the scope of accreditation is of great importance, in particular if a great number of similar routine tests (standard methods) or non-routine tests are to be accredited. The main tool of flexibilization is the accreditation of types of tests. The accreditation of types of tests entitles laboratories to include additional test methods within the type of test accredited without informing the accreditation body immediately. Such information is provided at fixed surveillance intervals. The conditions for the accreditation of types of tests are described below.     

Assessors’ attitudes toward and experiences of national quality standards: a qualitative study in Iran

To establish a national accreditation system for medical laboratories, Iran has set national standards based on the international standard ISO 15189. Central to the accreditation process are the technical assessors. Their attitude in this regard and their experiences should be identified. This study aims to explore assessors’ attitudes toward national laboratory accreditation and their experiences of assessment process in order to identify current gaps and suggest required interventions to solve them. A qualitative study using an open-ended questionnaire was employed. A total of 150 assessors working in the General Directorate of Laboratory Affairs participated in the study. While almost all Iranian laboratory accreditation assessors were generally supportive about the necessity of laboratory accreditation and cited benefits of this process, they pointed to improvement areas including developing assessor selection and appraisal criteria, continuous training, taking into consideration the heterogeneity of laboratories throughout the country, participation of professional associations and adopting measures to increase laboratories’ involvement.     

Towards accreditation of clinical biochemistry in the public sector on the island of Mauritius

Medical laboratories of the public sector as well as of the private sector on the island of Mauritius are preparing for accreditation. The clinical laboratory of the Central Health laboratory of the Ministry of Health and Quality of Life has undergone a pre-assessment by experts of the International Atomic Energy Agency (IAEA) through the aegis of a project targeted to members of the Africa Region. Several shortcomings were identified and respective corrective actions were recommended for implementation within a given time frame. In addition to ensuring the competence of the laboratory, accreditation has various positive aspects such as an increased awareness of the staff to quality and better training opportunities. The pre-assessment exercise has provided a gap analysis, which is an important aspect in the preparation towards accreditation.