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Accreditation of reference material producers: an update 总被引:1,自引:0,他引:1
Henry F. Steger 《Accreditation and quality assurance》2005,10(5):252-254
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R. F. Walker 《Accreditation and quality assurance》1999,4(8):360-365
The use of reference materials is the most pragmatic means by which the analyst can achieve comparability of data. Reference
material producers therefore need to have adequate quality systems in place for ensuring the reliability of their materials.
In order to provide guidance to both producers and assessors, ISO Guide 34 has recently been produced detailing the quality
system requirements for the production of reference materials. CITAC, REMCO and ILAC are now collaborating in the revision
of this guide to produce a free-standing document detailing the general requirements for the competence of reference material
producers. This paper discusses some of the more important issues described in these documents. The possible formation of
an international register containing details of a reference material producer's quality system status is also discussed. 相似文献
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The accreditation of testing and calibration laboratories to ISO/IEC 17025 is increasingly calling for the accreditation of reference material (RM) producers. Two international guides, ISO Guide 34 (2000) " General requirements for the competence of reference material producers" issued by the ISO Committee on Reference Materials and ILAC-G 12 " Guidelines for the requirements for the competence of reference material producers" issued by the International Laboratory Accreditation Cooperation (ILAC), are already in use for this purpose. Recently however initiatives have been launched to accredit RM producers to ISO 17025 as calibration laboratories and it has been suggested that a combination of ISO/IEC 17025 " General requirements for the competence of testing and calibration laboratories" and ISO Guide 34 may be the best option. This publication is an expression of the position of the ISO Committee on Reference Materials (ISO/REMCO) on the standards and guides currently in use in the accreditation of RM producers. The paper discusses the advantages and disadvantages of these standards and guides from the perspective of benefit to RM producers and RM users. In conclusion, the use of ISO Guide 34 alone or in combination with ILAC-G 12 is the preferred system for the accreditation of RM producers. Therefore ISO/REMCO strongly encourages all accreditation bodies to adopt ISO Guide 34. 相似文献
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Thomas P J Linsinger Alexander Bernreuther Philippe Corbisier Marta Dabrio Håkan Emteborg Andrea Held Andrée Lamberty Gaida Lapitajs Marina Ricci Gert Roebben Stefanie Trapmann Franz Ulberth Hendrik Emons 《Accreditation and quality assurance》2007,12(3-4):167-174
The potential approaches for third-party assessment of reference material producers are revisited and the activities of the
Reference Materials (RM) Unit of the Institute for Reference Materials and Measurements (IRMM) to obtain accreditation to
ISO Guide 34 and ISO 17025 are described. Accreditation was related to the Unit as all matrix RM activities of the institute
are concentrated there. A management system was established that allows sufficient flexibility to be applicable to a wide
range of RMs while being precise enough to ensure compliance with ISO Guides 30, 31 and especially 34 and 35. Accreditation
was achieved in 2004 with independent scopes for testing and RM production and was confirmed and extended in 2005. The key
aspects of the RM Unit's management system for RM production are presented.
Presented at BERM-10, April 2006, Charleston, SC, USA 相似文献
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N. Sagara T. Kondo M. Saeki I. Inamoto K. Kakita 《Accreditation and quality assurance》1997,2(3):120-129
ISO 9000 series strictly requires traceability to national or international measurement standards. It is becoming more necessary
to make clear the concept of traceability of measurement standards with respect to chemical composition and to accredit the
reference material producers. In Japan, the accreditation system for reference material producers is considered to satisfy
the requirement of ISO Guide 34, ISO 9000 series and ISO/IEC Guide 25, while the producer fulfills the concept of traceability
of measurement standards. This paper describes the production of iron and steel reference materials in Japan relating to the
international standardization of methods (written standards) and accreditation of reference material producers.
Received: 11 October 1996 Accepted: 5 December 1996 相似文献
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Manfred Golze 《Accreditation and quality assurance》2003,8(9):420-421
A third-party assessment of reference materials (RMs) and their production is not of the highest priority for RM users. But if RM producers do want a third-party involvement this should be realised within the frame of existing conformity assessment schemes. Nevertheless, the right and responsibility of the laboratories to select the most appropriate RMs for their tasks must not be restricted by accreditation bodies or other interested parties. 相似文献
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The National Analytical Reference Laboratory of the Australian Government Analytical Laboratories was initially accredited to ILAC Guide G 12:2000 in January 2000 and is currently accredited to ISO Guide 34 (2000) for the production of a range of pure organic substance reference materials. This paper discusses the practical challenges and rewards of developing and implementing a quality system for reference material production and discusses some of the barriers, and potential solutions, to more general implementation of third-party accreditation. 相似文献
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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). 相似文献
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Geoffrey R. Scollary 《Analytical and bioanalytical chemistry》1997,357(2):224-226
Post-graduate education in analytical chemistry in Australian universities does not have a high profile at the national level,
yet there is a significant demand from employers for graduates with qualifications in analytical chemistry. To meet this demand,
some specialist courses such as Graduate Diplomas and course work Master’s degrees have been established. These courses however
have a research component which is less than 50% of the total program. On the other hand, the traditional Master of Science
and Doctor of Philosophy degrees are research only degrees and follow on from a fourth year (Honours year) of university study
which may or may not have a course work component in analytical chemistry. The absence of course work past Year 4 produces
graduates with a high degree of specialisation but with a limited view of the relationship between analytical chemistry and
the social and R&D needs which drive research in analytical chemistry. It is argued that there should be a course work component
in Years 5, 6 and 7 and that this course work component should address both discipline and general skills issues.
Received: 15 January 1996/Accepted: 28 January 1996 相似文献
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Geoffrey R. Scollary 《Fresenius' Journal of Analytical Chemistry》1997,357(2):224-226
Post-graduate education in analytical chemistry in Australian universities does not have a high profile at the national level,
yet there is a significant demand from employers for graduates with qualifications in analytical chemistry. To meet this demand,
some specialist courses such as Graduate Diplomas and course work Master’s degrees have been established. These courses however
have a research component which is less than 50% of the total program. On the other hand, the traditional Master of Science
and Doctor of Philosophy degrees are research only degrees and follow on from a fourth year (Honours year) of university study
which may or may not have a course work component in analytical chemistry. The absence of course work past Year 4 produces
graduates with a high degree of specialisation but with a limited view of the relationship between analytical chemistry and
the social and R&D needs which drive research in analytical chemistry. It is argued that there should be a course work component
in Years 5, 6 and 7 and that this course work component should address both discipline and general skills issues.
Received: 15 January 1996/Accepted: 28 January 1996 相似文献
15.
Terry Spencer 《Accreditation and quality assurance》2005,10(6):308-314
This presentation deals with issues of comparability and traceability in food analysis in Australia from several perspectives. This includes the current national (Australian) and increasingly international (Codex) performance-based approach to food analysis. The Australian food regulatory process will be described, particularly those aspects that impact on the analysis of food in a regulatory sense. This section will also describe two areas where specific methods have been mandated in legislation and discuss two case studies where the analytical method has impacted on the elaboration of standards. Other areas to be covered include regulation/requirements relating to supply/availability of reference materials, the use of proficiency testing as a means of ensuring comparability, and, finally, some thoughts on what role BIPM/CCQM may play in the analysis of food.Electronic Supplementary Material Supplementary material is available for this article at
相似文献
Terry SpencerEmail: Phone: +612-6213-6102Fax: +612-6213-6815 |
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Wim P. Cofino 《Mikrochimica acta》1996,123(1-4):151-161
The comparability of data from accredited laboratories is not always as good as customers would desire. A number of reasons for this fact are given. Clients of laboratories do not specify methodology, which may lead to the application of systematically different methods or to methodology with improper performance characteristics. Laboratories do not always validate methodology sufficiently which is, however, among others provoked by a lack of reference materials. It is argued that accreditation cannot enforce comparability on itself, but needs to be embedded in a measurement infrastructure. The quality systems which underly accreditation form a basic element. In addition, adequate methods, good laboratory performance studies and certified reference materials are required. 相似文献
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Summary Carbon has been determined in the certified reference sample Euro CRM Pure Iron 097-1 to 3.98 g C/g (R = 0.15 at P = 95%) by combustion of the sample portion with subsequent indication of the CO2 by coulometry. A calibration material based on primary sources of carbon was used with a sufficient small interval of uncertainty of the accuracy and an adequate weighing system. The blank could be kept sufficiently small with a fraction of 23% of the total analytical signal. The surface carbon of the 097-1 was determined to approximately 50% of the total carbon. This result of total carbon is considerably lower than the values in the certificate reading up to 20 g/g. This reflects the strong tendency to too high values in the certificates of reference steels with contents of carbon up to 100 g/g. Examples are given.
Herstellung von Referenzmaterial — Bestimmung von Kohle in Stählen und reinem Eisen im Bereich von 1–100 g/g mit primärer Kalibrierung相似文献