实验室认可的要求与准备

介绍实验室质量体系的构成、实验室认可的要求，以及申请实验室认可应准备的相应资料及现场评审时应注意的事项。     

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。     

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。     

认可机制下实验室人员培训工作的组织与开展

针对部分实验室在人员培训工作中存在的培训模式不清、培训机制不健全、培训质量较低的问题,系统地分析了计量实验室人员培训所涉及的主要类别、内容及要求等。对培训工作的流程逐个进行详尽地描述,分内部培训和外部培训两个方面对培训中应注意的问题进行重点说明,为广大计量实验室管理人员开展人员培训工作提供借鉴。     

标准物质和实验室认可

论述了标准物质的定义及其在实验室认可中的作用,并介绍了标准物质在实际使用过程中应注意的事项。     

汕头检验检疫局食品实验室顺利通过评审

不久前,中国合格评定国家认可委员会委派两位评审专家对汕头局技术中心食品实验室进行了监督暨扩项评审。     

实验室认可量值溯源中几个问题的探讨

介绍量值溯源的含义,总结实验室量值溯源中常见的几个问题,提出了保证量值溯源有效性的措施和建议。     

实验室资质认定评审过程中共性问题的探讨

基层市、县级检测机构在检测/校准的一些关键点上存在着概念混淆和认识不足的问题,笔者就这些问题进行了一般性探讨,经分析认为,基层市、县级检测机构的生存和发展的必要保证是对人员的培训.     

2011年实验室资质认定评审工作要求

为了进一步提升实验室资质认定（国家计量认证）评审活动的质量和效率,规范行政审批流程,有关2011年实验室资质认定（国家计量认证）评审工作要求如下。     

中国认可实验室4255个居世界首位

不久前,国际认可论坛（IAF）和国际实验室认可合作组织（ILAC）联合大会在沪召开。ILAC和IAF是国际认证认可界的权威组织。长期以来,ILAC和IAF积极倡导在全球范围内建立一致、有效的合格评定认可体系,形成国际多边互认机制,促进认可的合格评定结果获得广泛的国际承认,从而达到减少贸易技术壁垒、促进国际经济贸易发展的目的。     

Joint Commission International accreditation: a laboratory perspective

Joint Commission International accreditation (JCIA) offers the international community a standards-based, objective process for evaluating healthcare organizations. The eleven JCIA standards are functionally organized. The standards are grouped by functions related to the provision of patient care and functions covering the provision of a safe, effective, and well-managed organization. The focus of the JCIA survey process is on the whole organization rather than on individual departments/services. The survey is carried out by trained and experienced healthcare peers. Healthcare organizations worldwide should be encouraged to seek accreditation such as that offered by JCIA. Where affordable, laboratories that are part of larger healthcare organizations should strive to achieve independent laboratory accreditation. The perspective of a laboratory undergoing a JCIA survey is briefly presented. Presented at the conference Quality in the Spotlight, March 2007, Antwerp, Belgium.     

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.     

Development of laboratory accreditation in the United States

 Laboratory accreditation in the United States is an old profession. Users and regulators have, it seems, been concerned about the quality of test data they obtain from laboratories for well over half a century. These users have developed many different systems to meet their needs. As a result, there is much duplication of effort and overlapping in accreditation requirements and many laboratories have to maintain current accreditation from a number of organizations. A number of attempts have been made over the years to reduce this duplication, but it still remains. In the meantime, rapid progress has been made internationally to recognize laboratory accreditation systems in different countries. This paper describes this situation and speculates on the future, considering the international thrust to simplify and consolidate conformity assessment procedures. Received: 26 May 1998 · Accepted: 6 June 1998     

The experience of accreditation of an analytical laboratory at the Argentine Atomic Energy Commission

The implementation of a quality system based on the ISO/IEC 17025:1999 standard is a growing necessity for analytical laboratories to demonstrate their technical competence. In 2001, the Nuclear Analytical Techniques Group of the Argentine Atomic Energy Commission obtained the recognition of the International Atomic Energy Agency in the application of neutron activation analysis and the accreditation by the national accreditation body. The importance of the participation of the group in the Agency's Regional Programme for Latin America, ARCAL XXVI on Quality Assurance in Analytical laboratories is discussed, as well as the activities performed to attain these objectives. Some improvements worth mentioning resulted from the implementation of the quality system and, following the premise of continuous improvement, changes were introduced aiming at the laboratory re-accreditation.     

The College of American Pathologists laboratory accreditation program

The College of American Pathologists (CAP) operates voluntary programs in proficiency testing (PT) and quality monitors, which are briefly described. Additionally, a peer-based laboratory accreditation program covers over 6,100 clinical laboratories. Participation requires successful PT and on-site inspections using a series of 18 checklists structured along traditional subdisciplines of laboratory medicine and anatomic pathology. The laboratory general checklist contains over 250 questions covering broad issues affecting all disciplines. Among these are three items within the computer services section that specifically probe the laboratory’s use of autoverification. Data autoverification is defined as the process by which the computer performs the initial verification of test results; any data that fall outside of set parameters should be reviewed by the human operator. Central to these questions is the role of the laboratory director in approving the rules and validation. CAP does not define the specific technical details, recognizing the uniqueness of each laboratory setting and the patients it serves. Received: 8 August 2002 Accepted: 10 August 2002 Presented at the European Conference on Quality in the Spotlight in Medical Laboratories, 7–9 October 2001, Antwerp, Belgium Correspondence to A. Rabinovitch     

Sense and nonsense of laboratory accreditation

 An open mind is essential for the implementation and improvement of total quality management. Leadership, as such, is of no value without a vision concerning corporate culture and human resources. Therefore, constant communication between partners within a corporate body is the cornerstone for empowerment. The evaluation of ideas and complaints is considered to be essential for the identification of strengths and weaknesses of a system, whereas, competition and benchmarking may reveal surprising opportunities for improvement. We discuss the idea that customer-oriented efficiency in a hospital environment may be classified as a critical success factor.     

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     

Is accreditation useful for quality improvement?

 The Laboratory of the Government Chemist (UK) and the Institute for Reference Measurements and Materials (Belgium) evaluated the correlation between accreditation and performance in proficiency tests. It was concluded that accreditation does not have the expected positive effect on the quality of laboratory results. In this journal discussions conducted on this subject during the CITAC workshop at Pittcon in 1998, were published. No satisfactory explanation for this phenomenon was put forward. In this article, it is proposed that the main effect of accreditation is a decrease of intralaboratory spread. The effect on the trueness of laboratory results is not significant due to the lack of certified reference materials and the low frequency of participation in proficiency tests. Proficiency tests cannot be used to find a correlation between accreditation status and quality without changing the set-up of the proficiency test.     

Experience of implementing ISO 17025 for the accreditation of a university testing laboratory

The experience of implementing a quality system on ISO 17025, and the accreditation of some tests for a university laboratory, is presented in the example of the Environmental Radiology Laboratory. Such implementation in a university institution is a difficult task, since the setting and environment are both unfavourable. The particularities are the collaboration of many independent units of the university, and the involvement of teachers and young researchers who have to coordinate all these different tasks, which makes the number of people working quite variable. Some specific aspects of the system are discussed. The conclusion is that implementation of a quality system on ISO 17025 and accreditation are completely achievable, and are helpful activities to put university members in touch with the real world and broaden their minds, which in the end has a positive impact on research studies and academic content.