良好实验室规范与实验室认证

良好实验室规范(GLP)作为一个管理系统,已成为国际上从事非临床安全性研究和实验研究所共同遵循的规范。实施GLP的目的确保试验结果的准确性和可靠性,最重要的是实现试验数据的相互认可(MAD)。欧盟REACH法规中关于物质注册的规定,也对我国的实验室认证工作提出了更高的要求。本文就目前在国际社会上得到广泛承认和实施的经济合作与发展组织(OECD)提出的GLP原则的发展概况与我国由此转化的国家GLP系列标准,以及我国的GLP认证情况进行综述;同时将OECD GLP与ISO/IEC 17025进行比较,为相关的检测机构提供重要信息。     

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     

Implementation of ISO/IEC 17025 standard in a nuclear analytical laboratory: The KAERI experience

The practical experience on the implementation of ISO/IEC 17025 compliant quality system in a nuclear analytical laboratory of the Korea Atomic Energy Research Institute (KAERI) is described. This paper summarizes the need for a quality system and accreditation, the process of a quality system implementation, the quality system structures, and the formal accreditation of our laboratory by the Korean Laboratory Accreditation Scheme (KOLAS). Also, the improvements in the management, technical and service quality which resulted from implementation of this system are briefly reported.     

Accreditation of sampling activities

Since the introduction of ISO/IEC 17025 it is a requirement for all accredited laboratories to include sampling in their quality statements. It is well understood that sampling and handling of the sample are key factors in the validity of a result. The fact that many laboratories worldwide are not involved in sampling poses a challenge to accreditors liability. This article describes the Israel Laboratory Accreditation Authoritys (ISRAC) and other accreditors approaches to sampling.Presented at the Second International Conference on Metrology—Trends and Applications in Calibration and Testing Laboratories, 4–6 November 2003, Eilat, Israel.     

Experience of implementing of ISO/IEC 17025: conclusions and recommendations of a workshop

The first experiences of implementing of ISO/IEC 17025 have been obtained by the accreditation bodies and laboratories following the standard, and a workshop to discuss the experiences was arranged. This presentation gives the conclusions and recommendations from the workshop based on the lectures and discussions. In general, the adoption of ISO/IEC 17025 has been a smooth process. Received: 28 February 2002 Accepted: 2 March 2002     

Management review checklist for ISO/IEC 17025 and ISO 15189 quality-management systems

Management reviews are key processes in many quality-management systems, including laboratory-management systems, in accordance with ISO/IEC 17025 and ISO 15189. These reviews are fine opportunities to understand and manage all the inputs and outputs of a quality-management system. Laboratories often meet some difficulties fully exploiting the management-review process because either they do not realize the importance of this process or they do not have the experience to run this process in a way producing the intended results. This work presents a management review checklist which helps laboratories carry out an effective management review going through all the important aspects of the quality-management system.     

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.     

Certification of reference materials and accreditation of reference material producers: Questionable terminology leads to confusion

In the view of the Deutscher Kalibrierdienst (DKD) , a certifying body for reference materials can be considered to be a calibration laboratory. Therefore, accreditation of calibration laboratories in accordance with ISO/IEC 17025 is the most appropriate way to establish confidence in certificates for reference materials. If necessary, the criteria of ISO/IEC 17025 can be tailored to specific cases. There is no need to provide any new kind of reference-material specific accreditation. However, in view of the variety of reference materials and the practice existing in other countries, accreditation of testing laboratories and product certification bodies may optionally be acceptable as long as the same stringent principles with respect to traceability and measurement uncertainty are applied. Such accreditations but not accreditations of reference material producers (ISO Guide 34) are also covered by existing international mutual recognition arrangements (MRA).     

Implementation of ISO/IEC 17025 Standard for the accreditation of analytical laboratories in Russia

The history since 1992 and the current state of affairs of the Russian Accreditation system for analytical laboratories are described. Some national characteristics of the implementation of the ISO/IEC 17025 Standard in Russia are considered. The elucidation of some ISO/IEC 17025 Standard prepositions is presented to facilitate implementation of the Standard by accreditation bodies and analytical laboratories claiming accreditation.     

药代动力学实验室液相色谱串联质谱仪期间核查方法的建立

建立符合ISO17025认可要求的药代动力学实验室中液相色谱串联质谱仪的期间核查方法。采用仪器状态及性能核查、仪器比对及全国室间质评等手段,对液相色谱质谱联用仪检测结果的有效性及准确性进行评价。结果为仪器状态及性能核查指标全部合格;仪器比对采用API 3200QTrap与API 4000的测试数据进行比较,结果两组间精密度(ρ=0.072,P>0.05)及均值(ρ=0.380,P>0.05)均无差异;全国室间质评5组盲样的测试浓度均在允许范围内,全部合格通过。2019年度液相色谱质谱联用仪期间核查结果为满意。期间核查可系统评价液相色谱质谱联用仪的性能,提高检测质量,以满足CNAS CL-01:2018对药代动力学实验室仪器的要求。     

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.     

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.     

Implementation of a quality management system in meteorological practice in Serbia

An optional approach in the meteorological service Quality Management System (QMS) based on the case study of the Republic Hydrometeorological Service (MHS) of Serbia is presented and discussed in this paper. The idea is to use the ISO/IEC 17025 standard as a base for its QMS development. Main reasons for such a decision and the elements of the implemented solution are presented and discussed. Meteorological testing processes of the MHS of Serbia and relevant ISO/IEC 17025 scope of accreditation are presented. After establishing competencies in meteorological, environmental, and hydrological testing, the MHS of Serbia will develop an integrative ISO 9001 QMS. The Serbian case study could be taken into consideration as one of the options related to the future World Meteorological Organization Quality Management Framework.     

Influence of a quality system complying with the requirements of ISO/IEC 17025 standard on the management of a gamma-ray spectrometry laboratory

The motives for and the implementation of a quality system complying with the requirements of the ISO/IEC 17025 standard in a gamma-ray spectrometry laboratory are briefly described, as well as its influence on the laboratory's work and output. The use of the quality system as a tool for managing and controlling the state of the laboratory is described. Two examples of control and improvement of the laboratory's performance are given.     

Revision of ISO guide 25

 ISO/IEC guide 25 is the internationally recognised base document for the accreditation of laboratories. Laboratory accreditation is a system of peer assessment and a formal recognition that a laboratory is competent to perform specific tests or types of tests ISO/IEC guide 25 plays a fundamental role in the life of the analytical chemist and is pivotal to the acceptance of the philosophy "once tested everywhere accepted" and to ensuring the mutual acceptance of test data. Within the EU, the attainment of accreditation to ISO/IEC guide 25 has become a way of life and it is now mandatory for laboratories engaged in certain regulatory work areas. Guide 25 is currently under revision and over the past 2 years or so it has been the subject of much debate among the calibration and testing community and it has engendered a considerable amount of written and oral comments. The latest revision entitled "Draft International Standard ISO/IEC DIS 17025: General Requirements for the Competence of Testing and Calibration Laboratories" was circulated to national standard organisations for their "comment and approval" in mid 1998. Voting on this document commenced on 9 July and terminates on 9 December 1998. It is anticipated that a final draft could be circulated in 1999. In accordance with the Vienna agreement this is a parallel ISO/CEN enquiry. This paper will discuss the implications of the technical requirements of the current document for analytical chemistry with particular emphasis on, the strengths, weaknesses and deficits inherent in the draft circulated in July 1998.     

Development and accreditation to ISO/IEC 17025 calibration status of a melting point measurement facility for the UK

A melting point measurement facility for the UK has been developed and accredited to ISO/IEC 17025 Calibration status for the determination of the liquefaction temperature of pure substances from 35 to 250°C. The facility is based upon a commercial instrument, i.e. an oil bath fitted with an aluminium block (Isotech, model 798 EHT), a precision multimeter (Isotech TTI-7), a thermocouple directly inserted in the sample under investigation and a platinum resistance thermometer (PRT) tracking the block temperature. The homogeneity of temperature bath/block was investigated and the PRT used for the traceability of the measurements was calibrated by NPL and traceable to ITS-90. The process was validated using four current LGC Certified Reference Materials (CRMs):

Construction and development of a new single-column simulated moving bed system on the laboratory scale

Simulated moving bed (SMB) chromatography combines high productivity and high purities with reduced buffer consumption. We have developed a laboratory scale single column SMB (SC-SMB) unit with all four separation zones in one column. Distributors embedded within the chromatographic medium allow introduction and withdrawal of liquid between the zones. This single column unit exhibits homogenous packing in all zones, reduced headspace, less complex tubing, fewer valves, and almost undisturbed plug flow between the separation zones. The separation performance of the column was investigated with two different binary model mixtures. Furthermore, the SC-SMB unit is operated with a modified AKTA Explorer workstation, which has been specifically developed for the handling of biological fluids.     

化学项目式学习的课程、教学与评价系统研究——北京师范大学化学教育研究团队20年研究历程与成果

北京师范大学化学教育研究团队经过20年对项目式学习的不断探索,在项目式学习课程教材资源建设、项目式教学理论研究和教学案例开发、评价系统设计、培训模式创建和学术研究等方面取得了丰硕的成果,团队的研究和实践成果在全国范围内得到推广和应用,产生了积极广泛的影响力。     

Detection capability of tetracyclines analysed by a fluorescence technique: comparison between bilinear and trilinear partial least squares models

According to the committee decision of 12 August 2002 (2002/657/EC) the capability of detection, CCβ, must be set in all analytical methods not only at concentration levels close to zero but also at the maximum permitted limit (PL). In this work we describe a methodology which evaluates the capability of detection of a fluorescence technique with soft calibration models (bilinear and trilinear PLS) to determine tetracyclines (group B1 substances from annex 1 of Directive 96/23/EC). Its estimation is based on the generalisation of the procedure described in International Union of Pure and Applied Chemistry and in the ISO standard 11843 for univariate signals which evaluates the probabilities of false positive (α) and false negative (β). The capability of detection, CCβ, estimated from the second-order signal and the trilinear PLS model is 9.93 μg l⁻¹ of tetracycline, 17.75 μg l⁻¹ of oxytetracycline and 26.31 μg l⁻¹ of chlortetracycline, setting α and β at 0.05. The capability of detection, CCβ, determined around the PL (100 μg kg⁻¹ in milk and muscle) with the second-order signal is 109.4 μg l⁻¹ of tetracycline, 117.0 μg l⁻¹ of oxytetracycline and 124.9 μg l⁻¹ of chlortetracycline, setting α and β at 0.05. The results were compared with those obtained with zero and first-order signals. The effect of the interferences on the capability of detection was also analysed as well as the number of standards used to build the models and their calibration range.When a tetracycline is quantified in presence of uncalibrated ones by means of the trilinear PLS model the errors oscillate between 14.70% for TC and 9.57% for OTC.