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     

Implementation of Good Laboratory Practices (NIT-DICLA-035, Inmetro) in a technological platforms network: the Fiocruz experience

The technological platforms network (TPN) of the Oswaldo Cruz Foundation was developed as the result of the need to provide technical and scientific services to the Brazilian public health and health research networks through the use of high cost, state-of-the-art, multiuser equipment. In order to improve the quality of the services offered, a quality management system (QMS) was implemented in a group of subunits of the TPN. To achieve the planned objectives, a review of all the existing guidelines was carried out first, which led to the choice of a Brazilian guideline: Inmetro NIT-DICLA-035, ??Good Laboratory Practices?? (GLP). The next steps were the choice of the platform subunits (Pilot Project), the drafting of relevant documentation, and the creation of a quality assurance structure as well as other activities. It was clear that a proper interpretation and understanding of GLP in these platforms could make a difference in the efficacy and effectiveness of the system defined. The expertise gained through the implementation of QMS in the Pilot Project has enabled GLP implementation in the other TPN subunit platforms.     

加强实验室管理工作初探

实验室管理是科研工作的重要保障,对实验室实行科学系统的管理是规范实验秩序、保证实验室正常运行和提高实验效果的必要手段.阐述了实验室管理的基本任务.提出了加强实验室管理的建议.     

The quality-management system in research implemented in the food and food process quality research laboratory of the French Food Safety Agency

The French Food Safety Agency is a public body incorporating 12 laboratories that perform research to support expertise and public decisions taken in the fields of sanitary safety of food, animal health, and veterinary drugs. On the request of the General Management of the Agency a quality-management system in research (QMSR) is being implemented in the Food and Food Process Quality Research Laboratory. The experimental QMSR is based on existing standards and documents, describing the provisions required for scientific and technical competence, quality management, and project management. Furthermore, this QMSR also incorporates specific notions of great importance for research activities such as the positive and negative non-conformities, the non-confirmation of hypotheses, and the principle of evaluation of a research activity by peers for both quality and scientific aspects.     

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.     

The quality-management system in research implemented in the food and food process quality research laboratory of the French Food Safety Agency

The French Food Safety Agency is a public body incorporating 12 laboratories that perform research to support expertise and public decisions taken in the fields of sanitary safety of food, animal health, and veterinary drugs. On the request of the General Management of the Agency a quality-management system in research (QMSR) is being implemented in the Food and Food Process Quality Research Laboratory. The experimental QMSR is based on existing standards and documents, describing the provisions required for scientific and technical competence, quality management, and project management. Furthermore, this QMSR also incorporates specific notions of great importance for research activities such as the positive and negative non-conformities, the non-confirmation of hypotheses, and the principle of evaluation of a research activity by peers for both quality and scientific aspects.

     

三维三层次全开放实验教学模式下大学生创新能力的培养——以中级无机化学实验为例

The "three-dimensional and three-level fully open" laboratory teaching mode, namely a fully open mode including three-dimensionson time, space and content as well asthree-levels from basic laboratory, professional laboratory to scientific research laboratory, aims to motivate undergraduate students to fully participate in scientific research from time and "space", and to take the fully open mode including contents and instruments based on the individual needs and development of students. Through the exploration and practice for many years, it is found that the laboratory teaching mode is conducive to bring the principle part-students-into full play and to cultivate the students' scientific research and innovative ability, and furthermore to enrich the connotation of "Project of Undergraduate Teaching Quality". Thus, it can provide qualified talents with innovative spirit and ability, together with competitive strength for the construction of an innovation-oriented country in the future.     

Implementation of ISO 9001 in a medical testing laboratory

 The Department of Clinical Chemistry and Molecular Genetics, within the Institute of Clinical Pathology and Medical Research at Westmead Hospital, is a medical testing laboratory operating within the public sector health system of New South Wales, Australia. It provides acute-care pathology services to Westmead Hospital (a 900-bed tertiary referral university teaching hospital) as well as to three district hospitals and three rural hospitals. In addition to these core clinical chemistry services, it offers approximately 150 specialised biochemistry, pharmacology, toxicology, trace metal and molecular genetics assays as a reference laboratory service. In 1993, the Department became Australia's first medical testing laboratory to be registered to ISO 9001-1987/AS3901-1987. In 1995, this certification was extended to AS/NZS ISO 9001-1994. We are currently preparing for further accreditation to ISO/IEC Guide 25-1990, with additional supplementary requirements for medical testing. This paper describes the Quality System that the Department developed and which has been successfully maintained and extended since original certification. Important features of the Quality System are: 1. Primary design of the Quality System to meet medical and customer needs, with subsequent addition of required ISO elements. 2. Use of national Quality Award criteria to identify key business processes. 3. Development of integrated technical non-conformance, customer complaint, staff suggestion, and quality system corrective action procedures. 4. Implementation without external resources. Our conclusions are that ISO 9000 Quality Systems can be applied to medical testing laboratories, and can be implemented with minimum resource costs. Improvements in technical and service quality and business performance have resulted from this process. However, implementation of ISO 9000 at the level of individual Departments is not ideal. Greater improvements are possible when this process is undertaken at the level of the entire organisation. Received: 9 September 1996 Accepted: 5 October 1996     

Quality issues in proficiency testing

 Proficiency testing is a means of assessing the ability of laboratories to competently perform specific tests and/or measurements. It supplements a laboratory's own internal quality control procedure by providing an additional external audit of their testing capability and provides laboratories with a sound basis for continuous improvement. It is also a means towards achieving comparability of measurement between laboratories. Participation is one of the few ways in which a laboratory can compare its performance with that of other laboratories. Good performance in proficiency testing schemes provides independent evidence and hence reassurance to the laboratory and its clients that its procedures, test methods and other laboratory operations are under control. For test results to have any credibility, they must be traceable to a standard of measurement, preferably in terms of SI units, and must be accompanied by a statement of uncertainty. Analytical chemists are coming to realise that this is just as true in their field as it is for physical measurements, and applies equally to proficiency testing results and laboratory test reports. Recent approaches toward ensuring the quality and comparability of proficiency testing schemes and the means of evaluating proficiency test results are described. These have led to the drafting of guidelines and subsequently to the development of international requirements for the competence of scheme providers. Received: 2 January 1999 · Accepted: 7 April 1999     

The operational status of the IMS radionuclide particulate network

A worldwide radionuclide network of 80 stations, 40 of which with noble-gas-detection capability, and part of the International Monitoring System (IMS) has been designed to monitor compliance to the Comprehensive Nuclear-Test-Ban Treaty (CTBT). Pending entry into force of the Treaty, the certified stations are provisionally operated. With about 70% of the network operational global coverage has been reached and an overall operating experience of more than 250 station year for the particulate network has been accumulated. To ensure minimum down time any operational problems are addressed within the organizations’ Operations and Maintenance Support System. Within this support system the operational performance is continuously assessed as well as particular problems identified. To address these problems, equipment failures, operational procedures, maintenance and sparing plans, and equipment obsolescence are continuously reviewed and improved. The current operational status of the network as well as the support strategy is presented.     

Current experiences with a quality management system for non-clinical research and development in pharmaceutical industry

Quality management is one of the most important issues in pharmaceutical research as it determines the validity and reliability of data, data and data evaluation being the central products of all research activities. In this business it is of outstanding importance to generate valid data for the assessment of drug development candidates to assure that the huge financial investment, which is based on such assessments, can be successful. Efficacy and safety of products are the final goals of such developments. Therefore, Merck/Merck Serono implemented an additional specifically developed quality management system that covers all areas and locations in Merck Serono Research that were not yet regulated by an existing regulatory quality management system, e.g. GLP (Good Laboratory Practice). The system is known under the name Merck Serono Research-Quality Management System (MSR-QMS). Thus, we describe the implementation process of MSR-QMS as a research specific quality management system in a global company. Furthermore, the implementation process in one specific research department will be highlighted. Using a practical example, the validation of an analytical instrument in a MSR-QMS-regulated research laboratory will be shown and compared to a validation process in a strictly GLP-regulated area. A summary of the experiences with the new quality system will complete this article and the advantages of high quality research results in industry will be discussed.     

ISO 17025: practical benefits of implementing a quality system

As a laboratory certified to ISO 9001:2000 and accredited to ISO 17025, rtech laboratories has incorporated an overall system for technical and quality management, which results in benefits observed in daily laboratory practices. Technical requirements were updated to include the addition of formal personnel training plans and detailed records, method development and validation procedures, measurement of method uncertainty, and a defined equipment calibration and maintenance program. In addition, a stronger definition of the sample preparation process was documented to maintain consistency in sampling, and a more rigorous quality control monitoring program was implemented for chemistry and microbiology. Management quality improvements focused on document control to maintain consistent analytical processes, improved monitoring of supplier performance, a contract review process for documenting customer requirements, and a system for handling customer comments and complaints, with continuous improvement through corrective and preventive action procedures and audits. Quarterly management review of corrective actions, nonconforming testing, and proficiency testing aid in determining long-term trending. The practical benefits of these technical and management quality improvements are seen on a daily basis in the laboratory. Faster identification and resolution of issues regarding methods, personnel or equipment, improved customer satisfaction, meeting quality requirements of specialized customers, and overall increased laboratory business are all the result of implementing an effective quality system.     

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.     

The establishment of quality systems in veterinary diagnostic testing laboratories in developing countries: experiences with the FAO/IAEA External Quality Assurance Programme

Quality systems, established to internationally accepted standards, are one mechanism that can assist in evaluations of the sustainability of technology transfer, the proficiency of the user, and the reliability and comparability of data generated, resulting in potential enhancement of laboratory credibility. The means of interpreting existing standards and implementing quality systems in developing country veterinary diagnostic laboratories has become a significant adjunct to the technology transfer element within the Food and Agriculture/ International Atomic Energy Agency, FAO/IAEA programme. The FAO/IAEA External Quality Assurance Programme (EQAP) is given as an example for an initial step towards enhancing the “quality” culture in developing country veterinary laboratories. In 1995 the EQAP began as an effort to assure that test results emanating from laboratories using FAO/IAEA ELISA kits for animal disease diagnosis are valid. For this purpose 15 international external quality-assurance rounds have been performed to date for a variety of animal diseases e.g. Rinderpest, brucellosis, trypanosomosis, and foot-and-mouth disease (FMD). Results indicate that the EQAP is a valuable tool in the assessment of both the results provided by, and use of the ELISA kits provided through, the joint FAO/IAEA programme. Furthermore EQAP can assist laboratory diagnosticians to enhance quality control/quality assurance (QC/QA) procedures for conducting FAO/IAEA ELISAs and to advise on the implementation of similar QC/QA procedures in other laboratory activities. Based on the experiences made during the implementation of the EQAP a proposal for establishing a quality system standard was ratified through the World Organization for Animal Health (OIE) general conference in May 2000. The OIE Standard On Management And Technical Requirements For Laboratories Conducting Tests For Infectious Animal Diseases is based on ISO 17025 and provides a clear formula for establishing quality systems in veterinary diagnostic laboratories world-wide.     

QASKI – the quality assurance system of the National Institute of Chemistry

 The quality assurance system (QASKI) developed and implemented in the National Institute of Chemistry is presented. It tries to eliminate the incompatibilies between the present methods of quality assurance used in research and development institutes such as good laboratory practice and accreditation. Since 1991, QASKI has been used for internal accreditation of laboratories located in the institute, regardless of the fact that some of them deal with routine analyses and others with research and development. Every laboratory that wishes to ensure the credibility of its research or routine work enters QASKI and at the same time chooses an external method of approval. All interested laboratories, study directors, principal investigators, internal auditing staff, heads of documentation, quality assurance unit staff, the Director of the institute and the Quality Management Board participate in the internal system.     

Introduction for the special issue on the Antwerp Conferences

Quality management of laboratory medicine has become a hot topic at many conferences. Also, many national and international organizations have created working groups and committees with the task of working out standards, guidelines or recommendations for quality management of medical laboratories. We have observed that there is a great deal of interest not only from professional and scientific organizations directly involved in medical laboratory tests, but also from accreditation and certification bodies, from test laboratories in general, from in vitro diagnostic devices (IVD) manufacturers and their associations, and from other medical laboratory suppliers. However, we found that all these parties were discussing from their own point of view, without taking into account the position of other involved partners and that there was a need for creating a discussion forum for quality management in clinical laboratories. So in 1995, we started the Antwerp conferences on quality (r)evolution in clinical laboratories. The aim was to bring together all concerned partners and to establish a forum for brainstorming, independently of any pressure group. The leitmotif for the Antwerp conferences (Fig. 1) is a chain model showing the interfaces and relationships between all the partners involved in laboratory tests. During the conferences, this chain model has been examined from different angles and a summary of the concepts evolving from the discussions can be found in the conference abstracts and conference review reports in this journal. A Selection of ideas emerging from these conferences are presented below. Received: 5 October 1998 · Accepted: 20 October 1998     

Clinical quality vs analytical performance: what are the right targets and target values?

For optimal performance of laboratory tests, testing processes should be designed to provide clinically useful quality and QC procedures should be selected to assure that the necessary clinical quality is achieved in routine production. One important issue is how to define clinical quality. Today’s practice guidelines, quality regulations, and quality standards provide some targets for analytical quality, but they fail to adequately address clinical quality. Target values for precision and accuracy are not the same as clinical quality, though analytical performance certainly contributes to the clinical quality of test results. How can we proceed in our quest to improve quality when there are inconsistencies and inadequacies in the specifications found in practice guidelines, regulations, and standards? Today target values are often being set for the wrong targets. A better approach is possible if we focus on test interpretation guidelines to define clinical quality, then derive specifications for the accuracy and precision that are appropriate for the method, as well the QC rules and numbers of control measurements that are necessary to guarantee the desired quality will be achieved in routine operation of the testing process.     

开放式大型仪器平台管理探索与实践

大型仪器设备是高校的重要资源,是教育教学与科学研究的重要支撑,探索高效便捷的大型仪器管理方式,提高仪器的使用率和使用价值是管理者的共同追求. 结合浙江大学高分子科学与工程学系实验中心平台的管理实践,探索了利用社交软件辅助开放式实验平台管理的方式,同时结合社交平台的辅助功能实现了实验平台优质、高效、便捷的管理,大大提升了仪器的使用率,提高了平台管理人员的工作效率.     

大气环境降水监测的质量控制方法

根据《环境监测质量管理规定》、《江苏省环境监测质量管理实施细则》及环境监测技术规范的要求,探讨了降水监测采样、样品保存技术、实验室分析的质量控制方法。采用不同采样方法、不同采样器同时采集15场降水,其降雨量、电导率、pH值的比对监测结果合格率均大于90%。经试验,降水各组分有效保存时间不同,其中NO_3~-,NH_4~+为3 d;F~-,Cl~-,SO_4~(2-)为14d;K~+,Na~+,Ca~(2+),Mg~(2+)为30 d。选择2家实验室对降水样品、空白样品、标准样品同时测试,结果显示,空白测定结果均低于方法检出限,标准曲线相关性系数r≥0.999 0,测定结果的相对标准偏差为1.4%~5.9%(n=6),加标回收率为89.8%~106%,标准样品的分析结果均合格。该方法能保证降水监测结果准确、可靠,满足HJ/T 165-2004《酸沉降监测技术规范》的要求。