Accreditation of reference material producers

 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.     

The NATA scheme for accreditation of certifiers of reference materials

 Certified reference materials are widely used for the calibration of measuring equipment and for the evaluation or validation of measurement procedures. The use of reference materials makes possible the transfer of the values of measured or assigned quantities between testing, analytical and measurement laboratories, both nationally and internationally. There is an increasing number of reference materials producers in other countries, and a demonstration of their scientific and technical competence is now more widely considered to be a basic requirement for ensuring the quality of reference materials. This article outlines recent activities by international bodies and their culmination in a scheme of accreditation of certifiers of reference materials which has been developed by the National Association of Testing Authorities, Australia (NATA).     

The view of IRMM on accreditation of CRM producers

This article describes the views of IRMM on accreditation of CRM producers and the philosophy which is behind these views. More specifically, it explains the reasons for choosing ISO Guide 34 rather than ISO/IEC 17025 as the basis document for the proposed accreditation of its CRM activites. Received: 27 May 2002 Accepted: 11 July 2002 Acknowledgements Information on accreditation programmes in Australia and USA provided by Maree Stuart (NATA) and Randall V. Querry (AL2A) is greatly acknowledged. Correspondence to J. Pauwels     

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).     

Accreditation of RM producers: what does it mean?

A comparative study of different papers published in this special edition of ACQUAL "Accreditaton of RM producers" (see Editorial) is presented. The main question is: Is accreditation the key to guaranteeing the quality of RMs or is it certification? The arguments and different options of the authors are compared and evaluated against existing rules and present practice. In the conclusion options are given which depend on the type of RM producer (namely, laboratory or product certification body), and which could be acceptable to the community of analysts and metrologists, as well as to the market.     

How to approach membership of IAF/ILAC Arrangements: the peer evaluation system of IAF and ILAC for single accreditation bodies

Peer evaluation is used by the international accreditation organisations IAF and ILAC as a tool to harmonise the results of accreditation of conformity assessment bodies and as a control mechanism to ensure constantly competent services according to harmonized standards. Upon positive evaluation outcome, the accreditation body may join an Arrangement (MLA/MRA) between accreditation bodies, confirming systematic reliability and competence to the market. The objective of these Arrangements is that they will cover all accreditation bodies in all countries in the world, thus eliminating the need for suppliers of products or services to be certified in each country where they sell their products or services. This article is to aid single accreditation bodies wishing to sign these Arrangements in the future, and, furthermore, to communicate the procedure and the relevance of evaluation to the public in order to build up confidence in such Arrangements.     

Accreditation of reference material producers: the example of IRMM's Reference Materials Unit

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     

Flexibilization of the scope of accreditation: an important asset for food and water microbiology laboratories

Beltest, the Belgian accreditation body, has investigated flexibilization of the scope of accreditation for chemistry laboratories and food and water microbiology laboratories. This flexibilization, synonymous with test-type accreditation, allows a laboratory to add new test methods or retry previous test methods without having to undergo a new audit by Beltest. It has been used for nearly ten years by German and Swiss accreditation bodies. Flexibilization permits the validation of methods and results, given that the competence of the particular laboratory is already well established. This new concept in microbiology allows client’s needs to be adequately met, and facilitates the quick establishment of a method in several laboratories at once in case of a public health crisis. The first laboratory to participate at this investigation on the flexibilization concept, as a test of the concept, was the Belgian reference laboratory for food microbiology.     

A combination of accreditation and certification in an evolving process at EMPA: A management system to meet ISO 9001, ISO 14001 and EN 45001

 The Swiss Federal Laboratories for Materials Testing and Research (EMPA) have established a quality assurance system based on EN 45001 which meets the requirements for accreditation of all EMPA's testing activities. As testing is only a part of EMPA's range of activities, and is performed in decentralised departments, the system does not satisfy the management needs. The fundamental reorganisation of EMPA's St. Gallen site was used as an opportunity to implement an overall process-oriented management system which also included quality and the needs for accreditation. Later, an environmental management system was added and then certified for ISO 9001 and 14001. The system consists of a "Management Manual" for the St. Gallen site and a customised "Quality Manual" for each department. One of the key elements is a comprehensive review and planning procedure covering all business aspects.     

Implementing the GUM in the certification of reference materials: the revision of ISO Guide 35

The availability of certified reference materials, certified in accordance to the GUM is an important tool for the proper estimation of measurement uncertainty in routine analysis. Many CRMs may suffer from incomplete or wrongly estimated uncertainties, mainly due to lack of guidance on how to implement the GUM in the production of CRMs. In particular the inclusion of the impact of inhomogeneity and instability in the uncertainty budget is often missing. The ongoing revision of ISO Guide 35 aims to fill this gap in providing guidance how (batch) inhomogeneity and instability can be translated into measurement uncertainty. The structure of the current ISO Guide 35 has been maintained as far as possible, but major parts underwent revision to become better aligned with GUM and ISO Guide 34 (2000). Received: 9 April 2001 Accepted: 22 October 2001     

Production of “in house” reference materials for ELISA screening of bovine urine and liver samples for clenbuterol

Clenbuterol screening of bovines is done by analysis of urine, for monitoring living animals, and liver, for monitoring animals after slaughter. ELISA has generally been used as the main method for these purposes. Nevertheless, in Europe, methods must be validated according to Commission Decision (EC) 657/2007 criteria, i.e. by use of reference materials. Production of “in house” reference materials is a possibility, but the homogeneity, storage temperature, and period of stability of these materials must be investigated in the laboratory itself. This paper reports GC–MS evaluation of an “in-house”-produced batch of aliquots of bovine urine and liver, fortified with 10.0 ng/ml and 10.0 ng/g clenbuterol, respectively, and stored at ?20 °C and at ?60 °C. For urine stored for 20 weeks at ?20 °C and at 60 °C the stability of clenbuterol was proved at the 95% confidence level. For liver, however, it was demonstrated at the same confidence level that clenbuterol was highly unstable during storage for 20 weeks at either of the temperatures studied.     

A new phosphor with flower-like structure and luminescent properties of Sr<Subscript>2</Subscript>MgSi<Subscript>2</Subscript>O<Subscript>7</Subscript>: Eu<Superscript>2+</Superscript>, Dy<Superscript>3+</Superscript> long afterglow materials by sol–gel method

The flower-like phosphors of Sr₂MgSi₂O₇: Eu²⁺, Dy³⁺ with high brightness and long afterglow were obtained by sol–gel method. X-ray diffraction pattern (XRD) shows that single-phased Sr₂MgSi₂O₇ phosphor is prepared by sol–gel method under 1250 °C. Scanning electron microscope (SEM) indicates that the phosphor consists of nano-sized whiskers which are detected for the first time in Eu²⁺ and Dy³⁺ co-doped long-lasting phosphorescence silicates. Furthermore, the investigation on the mechanism indicates that the internal structure and gas, liquid and solid phase effect play important roles in the formation of flower-like Sr₂MgSi₂O₇: Eu²⁺, Dy³⁺ nanostructure. Finally, the optical properties of flower-like Sr₂MgSi₂O₇ nanostructure have been characterized by photoluminescence (PL) spectra.