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Accreditation and Quality Assurance: Journal for Quality, Comparability and Reliability in Chemical Measurement (v.8, #9)
Accreditation of RM producers: what does it mean? by Patrice Ackermann (pp. 394-404).
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.
Keywords: Reference materials; Accreditation; Certification; Testing or calibration laboratory; Product certification body
Accreditation of reference material producers: an Australian perspective by Maree Ann Stuart; Rod Millar; Gary Price (pp. 405-407).
The National Association of Testing Authorities, Australia has operated an accreditation program for reference material producers since 1997 with accreditation now being offered to ISO Guide 34 (2000). This paper discusses the benefits and disadvantages to both the producers and the users of reference materials (testing laboratories) and their clients of a formal system of third-party accreditation of reference material producers. The merits of using ISO Guide 34 (2000) rather than ISO/IEC 17025 as the core standard in the accreditation process are discussed.
Keywords: Reference material; Accreditation; Producer
Certification of reference materials and accreditation of reference material producers: Questionable terminology leads to confusion by Klaus Brinkmann; Martin Czaske; Wolfgang Bosch (pp. 408-412).
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).
Keywords: Reference material; Accreditation; Reference material producer; ISO Guide 34; ISO/IEC 17025
Accreditation of reference material producers or certification of reference materials?
by Anita Schmidt (pp. 413-414).
Accreditation of reference material producers: Let's get it right! by Henry F. Steger (pp. 415-419).
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.
Keywords: Accreditation; Reference material producer; ISO Guide 34; ISO/REMCO
The accreditation of reference material producers — EUROLAB's position by Manfred Golze (pp. 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.
Keywords: RM producers; Third-party assessment; Reference Materials
Stand alone accreditation of RM producers: arguments against it by Bernd Steffen (pp. 422-423).
Accreditation has a special responsibility in the European conformity assessment system. Before starting a new activity like stand alone accreditation of reference material producers, the consequences for the market place should be considered.
Keywords: Reference materials; Accreditation; Product certification; ILAC; EA–EUROLAB–EURACHEM–EUROMET–RM–Group
Implementation of ISO Guide 34: Accreditation for reference material production by Steven Westwood; Bernard King; Bruce Noble (pp. 424-427).
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.
Keywords: Reference materials production; ISO Guide 34; Accreditation; Quality assurance; Anabolic steroids; Forensic drugs
The selection and use of reference materials - a basic guide for laboratories and accreditation bodies
(pp. 429-433).
The external review committee on pure reference materials at the National Analytical Reference Laboratory by D. Brynn Hibbert; Steven Westwood (pp. 434-435).
The preceding paper described the implementation of a quality assurance system suitable for accreditation to ISO Guide 34 by the Pure Substance Reference Material (PSRM) team of the National Analytical Reference Laboratory (NARL). One of the key components of this system has been the establishment of an external advisory committee that scrutinises each candidate material that is to be offered as a reference material. At the time of writing 190 reference materials were available from NARL, including a range of illicit drugs and agricultural chemicals in addition to anabolic steroids and their metabolites, and all have been reviewed by the external committee prior to final approval by the accredited production signatory.
Keywords: Reference Materials; External Review Committee; Accreditation of RM laboratories
Objectives and roles of "accreditation" and "certification" of laboratories
by Graeme Drake (pp. 441-441).