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Accreditation and Quality Assurance: Journal for Quality, Comparability and Reliability in Chemical Measurement (v.10, #11)
Quality system implementation in Member States of the IAEA by Matthias Rossbach; Jane Gerardo-Abaya; Aleš Fajgelj; Peter Bode; Peter Vermaercke; Michael Bickel (pp. 583-589).
The International Atomic Energy Agency (IAEA), through its Technical Co-operation Programme, has supported the establishment of many nuclear analytical and complementary laboratories in Member States. This included the development of capabilities for the use of various nuclear analytical techniques that include alpha, beta, and gamma spectrometry; radiochemical analysis; neutron activation analysis; energy dispersive X-ray fluorescence analysis; and total reflection X-ray fluorescence. As economic, ecological, medical, and legal decisions are frequently based on laboratory results, they need to be based on accepted national and international standards.The IAEA has taken up this important issue to enhance and foster the competitiveness of nuclear analytical laboratories with the consideration that non-nuclear capabilities are equally important. The projects aim at enhanced quality awareness, a concise system for documentation, establishment of standard operating procedures, procedures for validation of methods, surveillance of method performance, systems for sample management, regular qualification of personnel, client liaison and safety. These projects follow the ISO/IEC 17025 standard and promote participating laboratories to maintain a self-sufficient quality system by which they might be able to obtain national accreditation.This contribution describes the general concept of these projects and discusses some of the results achieved.
Keywords: Technical cooperation; Quality systems; Accreditation; IAEA; Member States
The experience of accreditation of an analytical laboratory at the Argentine Atomic Energy Commission by Sara M. Resnizky; Rita R. Plá; Raquel C. Jasan; Sonia E. Hevia; Mónica A. Moreno; Rodrigo Invenizzi (pp. 590-593).
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.
Keywords: Quality system; Laboratory accreditation; Neutron activation analysis
Quality system implementation in a Brazilian university laboratory by Elisabete A. De Nadai Fernandes; Márcio Arruda Bacchi; Fábio Sileno Tagliaferro; Cláudio Luiz Gonzaga; Elvis Joacir De França; Paulo Cesar Favaro; Adriana de Angelis Fogaça (pp. 594-598).
The introduction of quality systems in laboratories at universities is a difficult task. Test services for external customers are provided to generate additional budget, and there may be a clear awareness about the need for systematic QA/QC actions. However, offering services is not of the highest priority within most university environments. The staff performance is commonly evaluated on basis of published papers and teaching activities, giving little or no weight for the test services. Therefore, implementation of a quality system is often pushed back to a lower priority leading to postponement. The efforts for creating a quality system in a laboratory from a Brazilian university are described in this paper, along with the results produced.
On the way to formal accreditation by Nora Vajda; Marta Balla; Zsuzsa Molnar; Denes Bodizs (pp. 599-602).
The Radiochemical Laboratory participated in the Technical Co-operation (TC) Project on Quality Control and Quality Assurance for Nuclear Analytical Techniques RER/2/004 organized by the International Atomic Energy Agency (IAEA) during the period June 1999 and September 2001. Motivations, major goals of participation in the project, milestones of implementation of the project, establishing the quality system, improvements fulfilling both technical and management requirements as well as major achievements for future activities of the laboratory with respect to technical and financial conditions are discussed in detail.
Keywords: Alpha-; Beta-and gamma spectrometry; Neutron activation analysis; Radionuclides; Method-validation; Accreditation
Implementation of ISO/IEC 17025 standard in a nuclear analytical laboratory: The KAERI experience by Kun Ho Chung; Geun Sik Choi; Wanno Lee; Young Hyun Cho; Chang Woo Lee (pp. 603-605).
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.
Keywords: ISO/IEC 17025 Standard; Implementation experience; Accreditation; Nuclear analytical laboratory; KOLAS
Towards accreditation of clinical biochemistry in the public sector on the island of Mauritius by F. Hemraj; D. L. Dhondee (pp. 606-608).
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.
Keywords: Clinical biochemistry; Accreditation; ISO/IEC 17025; Technical competence; Quality Policy; Quality Management
Influence of a quality system complying with the requirements of ISO/IEC 17025 standard on the management of a gamma-ray spectrometry laboratory by D. Glavič-Cindro; M. Korun (pp. 609-612).
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.
Keywords: ISO 17025; Gamma spectrometry; Quality system; Accreditation
Establishment of a quality system at the Nuclear Analytical Laboratories of the Atomic Energy Authority, Sri Lanka by M. C. Shirani Seneviratne (pp. 613-616).
A quality system according to the requirements of ISO/IEC guidelines has been introduced at the Nuclear Analytical Laboratories of the Atomic Energy Authority, which has received appreciation from International Atomic Energy Agency (IAEA) inspection evaluation reports (RAS/2/010) showing a positive indication to accreditation. The quality system has achieved the “analytical quality” through technical competence by non-conformance management. The experience in the progression towards achieving a quality system is described with examples from zero level to a positive index. This nuclear analytical service laboratory shows long-term stability of performance and enhances its credibility to customers, through the quality system.
Evaluation of laboratory performance in IMEP water interlaboratory comparisons by Martina Bednarova; Yetunde Aregbe; Caroline Harper; Philip D. P. Taylor (pp. 617-626).
The aim of International Evaluation Programme (IMEP) is to present objectively the quality of chemical measurements. Participants in IMEP compare their reported measurement results with independent external certified reference values with demonstrated traceability and uncertainty, as evaluated according to international guidelines. Three major interlaboratory comparisons (ILCs), IMEP-6, IMEP-9 and IMEP-12, on trace elements in water were carried out from 1994 to 2000. Participants' results for Cd, Fe and Pb concentrations from these three different IMEP water ILCs were compared by means of suitable performance indicators. The performance evaluation criteria were set according to the requirements stated in the Council Directive 98/83/EC of 3 November 1998 on the quality of water intended for human consumption. Two different performance indicators were selected for evaluation of the individual participants' results: the commonly used z-score and the not so well-known E n number. The group performance indicator is based on the variation of z-scores. To assess the individual measurement performance, not only the deviation of the reported measurement values from the certified reference value, but also criteria for maximum and minimum acceptable uncertainties were taken into account. The participants' performance is also reviewed by means of using a simple graphical tool, called “Naji-plots”.
Keywords: Measurement performance evaluation; IMEP; Naji-plots; E n number; Uncertainty; Trace elements; Water directive
Uncertainty of determination of palladium in road dust sample by inductively coupled plasma mass spectrometry by Jan Polák; Oto Mestek; Miloslav Suchánek (pp. 627-632).
The determination of palladium in a road dust sample taken close to the highway (w Pd=450 ng g−1) was carried out by the ICP-MS method after sample decomposition by aqua-regia. Analyses were evaluated by two methods: external calibration accompanied with mathematical correction of spectral interferences (EC) and isotope dilution measurement after separation of Pd by extraction to dibutyl sulfide solution (ID). In both cases, the uncertainties and accuracy of results were investigated. Although in the case of ideally homogeneous sample the repeatability of EC results (11 ng g−1 Pd) was somewhat lower than those of ID results (16 ng g−1 Pd), the uncertainties of results of both techniques were almost the same and they reached the level of 19 ng g−1 Pd. The main uncertainty source of the EC method is represented by the correction of spectral interferences. In case of real non-homogeneous sample, the main uncertainty component represents the soil sampling. The uncertainty of results (approx. 75 ng g−1 Pd) only slightly exceeded the repeatability (approx. 70 ng g−1 Pd). The accuracy of results was proven by analyses of CRM TDB–1 Diabas Rock (in case of ID) and by the standard addition method (in case of EC).
Keywords: Palladium; Isotope dilution; Mass spectrometry; Soils; Uncertainty
Traceability system for elemental analysis by Heinrich Kipphardt; Ralf Matschat; Olaf Rienitz; Detlef Schiel; Wolfgang Gernand; Dietmar Oeter (pp. 633-639).
A complete metrological traceability system for measurement results of chemical analysis was set up. Core components are pure substances (national standards) characterised at the highest metrological level, primary solutions prepared from these pure substances and secondary solutions deduced from the primary solutions and intended for sale. The relative uncertainty of the element mass fraction of the primary substances and solutions is < 0.01 and < 0.05%, respectively. For the certification of transfer solutions and for stability testing, a precision measurement method for element contents has been developed by means of optical emission spectrometry (ICP OES) by which uncertainties between 0.1 and 0.05% can be achieved. The dissemination to field laboratories is effected with the aid of a calibration laboratory of the German Calibration Service (DKD) which certifies the element content of the secondary solutions with an uncertainty ≤ 0.3%. Calibration with these solutions enables the user to establish traceability of his measurement results to the International System of Units (SI). Currently, the system comprises Cu, Fe, Bi, Ga, Si, Na, K, Sn, W, and Pb.
Keywords: Elemental analysis; Traceability; Elemental calibration solutions; Pure substances; Precision measurement of elements