Introduction to the new ISO 33400 series of standards: outcome of the transformation of the ISO/REMCO Guides for the production and use of reference materials

The need for reference materials for quality control of analysis of foodstuffs has been stressed frequently. This has been particularly true in the phycotoxins field, where there is a great shortage of both pure calibration standards and reference materials. Worldwide there are very few independent bodies that produce certified reference materials for phycotoxins, the main producers currently being the National Research Council Canada and the Japanese Food Research Laboratory. Limited availability of contaminated shellfish and algae, as well as the time and knowledge necessary for the production of adequate reference materials, continuously lead to limited editions of certified reference materials and even more limited production of in-house reference materials. The restricted availability of in-house quality control materials promotes the rapid use of the limited certified reference materials, which in turn hampers the production of the suite of materials required globally for complete protection of public health. This paper outlines the various options that analysts can pursue in the use of reference materials for internal and external quality control, with a view to optimising the efforts of both reference materials users and reference materials producers. For this purpose, the logical sequence is reviewed from the discovery of a new bioactive compound in shellfish, through initial method development up to regulation for food safety purposes including accepted reference methods. Subsequently, the requirements for and efforts typically spent in the production and characterisation of laboratory reference materials, certified reference materials and other test materials used in inter-laboratory studies or proficiency testing, in the area of marine biotoxins are evaluated. Particular emphasis is put on practical advice for the preparation of in-house reference materials. The intricate link between reference material characterisation and method performance is outlined to give guidance on the appropriate in-house method validation in the rapidly developing field of phycotoxins.

The Use of Matrix Reference Materials in Environmental Analytical Processes: A. Fajgelj, M. Parkany (Eds.), RSC, Cambridge, 1999, pp. x+206, ISBN 0-85404-739-5

The International Organisation for Standardisation (ISO) is a federation of national standards bodies that has developed a number of international agreements concerning the standardisation of various commercial and scientific activities which have been published as technical standards and guides. Several of the documents describe the way in which measurements should be made to ensure that all laboratories measuring the same quantity in the same material will produce results that are in harmony with one another. Others describe universally accepted practices for the production and use of reference materials. A summary of the ISO guides most relevant to the production of geochemical reference materials is presented; producers of these materials are encouraged to accept these guides in the interest of increasing the credibility and status of reference materials available to the geoanalytical community.

Vitamins are essential nutrients commonly found in food products in general and health supplements in particular. In order to accurately evaluate product quality, laboratories need to use reference material in analysis, proficiency assessment, method validation and ensure the validity of the results. The use of reference materials plays an important role in the quality control of test results and is a mandatory requirement for laboratories wishing to demonstrate appropriate competence as required by ISO/IEC 17025:2017. The need to provide reference materials for laboratories is huge. However, at present, there are very few domestic organizations that can produce reference materials, while the cost of buying reference materials from reputable firms in the world is expensive. In this study, we introduced the procedure and production reference materials for the analysis of B-group vitamins (B1, B2, B6). These reference materials were evaluated for homogeneity and stability in 322 days. The certified values are consistent with the concentrations of substances present in normal samples in practice. The measurement uncertainty ranges from 14.5 - 23.3 %. The reference materials can be used for internal quality control for domestic laboratories and is also a premise for further research on standard samples with different matrix and analytical criteria.

The function of solid sampling graphite furnace atomic absorption spectrometry (SS-GFAAS) in the laboratory-internal preparation, production and standardization of several animal tissue reference materials is described. SS-GFAAS is successfully applied in the production of a bovine liver reference material with a low content of Pb and Cd. The lab-internal production of 5 bovine teeth and 2 bovine bone reference materials illustrates some of the basic problems entailed in the analysis of Pb in osseus matrices and in the production of the reference material itself. In the production of muscle tissue reference material focal or generalized calcification is a serious source of endogenous Pb contamination. This is shown, by way of example, in the calcification of the larval states of Taenia saginata (Cysticercus bovis) in the bovine muscle. Finally, as further examples of the application of SS-GFAAS, the lab-internal production of reference material from bovine blood and equine renal cortex is described.

The function of solid sampling graphite furnace atomic absorption spectrometry (SS-GFAAS) in the laboratory-internal preparation, production and standardization of bovine liver reference material is described. Analytical quality assurance was achieved by using a wet digestion decomposition procedure and GFAAS (WD-GFAAS) as well as three different methods of SS-GFAAS. It will be shown, that SS-GFAAS is an adequate and efficacious method of analytical quality control in the production of reference materials. Details are given about the preliminary steps of sample selection and preparation, applying SS-GFAAS both as a screening method and for the detection of contamination during the production of the reference materials. The element contents of the four bovine liver materials measured after decomposition with nitric acid in the open system by GFAAS and also by Flame-AAS, using the ‘slotted tube atom trap’, are compared statistically with the results obtained by SS-GFAAS. In solid sampling analyses three different systems were applied: a solid sampling ZAA-spectrometer with platform-boat, a D2AA-spectrometer with solid sampling graphite tube and platform-drawer and an autoprobe-D2AA-spectrometer with solid sampling autoprobe and graphite tube.

Chapter 12 - Production, role and use of reference materials for nanoparticle characterization

Quality system requirements for the production of reference materials

Final dissolved organic carbon broad community intercalibration and preliminary use of DOC reference materials

Some Aspects Of the use of Reference Measurements and Reference Materials in “Euregios”

The 12th international symposium on biological and environmental reference materials (BERM 12), which was held at Keble College, Oxford, UK on 7–10 July 2009, continued a series which began in 1983 and has been held on a regular basis since then. The event originated as an informal gathering of interested scientists, particularly those working in Europe and the USA between which the meetings alternated every 2 or 3 years. More recently, BERM has been steered by a permanent committee comprising many of the major reference material producers and other key players. Asia has seen rapidly increasing interest in the field and the BERM 11 meeting was held in Japan. Hence, BERM 12 was a truly global forum which addressed the development of biological and environmental reference materials and their use in the calibration, validation and quality assurance of analytical measurements. As with previous symposia, the scientific programme for BERM 12 encouraged discussion of issues ranging widely from novel methods for the manufacture and certification of reference materials to topics such as quality assurance and international harmonization. This special issue of ACQUAL focuses attention on some aspects of BERM 12 of interest to both the suppliers and the users of reference materials. The topics include undertaking stability studies, metrological traceability, approaches to certification, and the use of reference materials in proficiency testing. A reoccurring theme in these papers and many presentations at the symposium is the importance, to both reference material producers and users, of the guides and standards prepared by the ISO Reference Materials Committee, REMCO. Unfortunately, it is also apparent that several of the presently available documents lack clarity and give rise to confusion due, for example, to conflicting requirements between different guides. Many of the delegates to ISO REMCO also participated in BERM 12 and should be aware of the issues. One reason for the present situation is the lack of discussion of new guidance with its potential users, such as those who attend BERM. The pages of ACQUAL would provide an ideal forum to obtain a broad church of views on key concepts before these documents are finalised. I hope that those concerned will use this and other possibilities to ensure that by the next BERM meeting in 2012 we have a coherent set of guides and standards which meet the needs of all concerned with reference materials. This will play a major part in achieving the ultimate goal of both BERM and ISO REMCO, namely improving the reliability of analytical data. Mike Sargent Chairman, BERM 12 Scientific Committee Guest Editor

The use of (certified) reference materials and quality control materials can form a suitable basis for evaluating measurement uncertainty of routine measurements. In particular when these materials are used for quality control purposes, it is not always evident how the quality control data can be used in the uncertainty budget of a routine measurement. Current guidance documents on the evaluation of measurement uncertainty and the use of reference materials treat this subject only in part, or in very generic terms. ISO/REMCO has established a new working group that will provide practical guidance and examples on how to use quality control data in the evaluation of measurement uncertainty. A short introduction to the subject is given.

This chapter aims at a description of the application and proper use of reference materials in gas analysis. It is not a treatise on gas analysis; there are numerous and excellent textbooks available dealing with that subject ([7.1] and [7.2], to name just two). Here, gas analytical techniques will only be mentioned if relevant to the use of gaseous reference materials.

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.

15.3 - Reference Materials in Geochemical and Environmental Research