The Eurachem reading list

9. Quality assurance and accreditation

Standards

  • ISO 13485:2016 Medical devices -- Quality management systems -- Requirements for regulatory purposes (www.iso.org)
  • ISO 78-2:1999. Chemistry -- Layouts for standards ­-- Part 2: Methods of chemical analysis. (www.iso.org)
  • ISO 9000:2015. Quality management systems -- Fundamentals and vocabulary. (www.iso.org)
  • ISO 9001:2015. Quality management systems - Requirements (and Corrigendum 1:2009). (www.iso.org)
  • ISO 9004:2018. Quality management -- Quality of an organization -- Guidance to achieve sustained success. (www.iso.org)
  • ISO 15189:2012. Medical laboratories -- Requirements for quality and competence. (www.iso.org)
  • ISO 15193:2009. In vitro diagnostic medical devices -- Measurement of quantities in samples of biological origin -- Requirements for content and presentation of reference measurement procedures. (www.iso.org)
  • 15194:2009. In vitro diagnostic medical devices -- Measurement of quantities in samples of biological origin -- Requirements for certified reference materials and the content of supporting documentation. (www.iso.org)
  • ISO 15195:2003. Laboratory medicine -- Requirements for reference measurement laboratories. (www.iso.org)
  • ISO/IEC 17000:2004. Conformity assessment. Vocabulary and general principles. (www.iso.org)
  • ISO/IEC 17011:2017. Conformity assessment -- Requirements for accreditation bodies accrediting conformity assessment bodies (www.iso.org)
  • ISO/IEC 17024:2012. Conformity assessment -- General requirements for bodies operating certification of persons. (www.iso.org)
  • ISO/IEC 17025:2017. General requirements for the competence of calibrating and testing laboratories (www.iso.org)

Guides

  • Handbook ISO/IEC 17025:2017, Eurolab, 2017 (www.eurolab.org/cookbooks)
  • Tool for Transition from ISO 17025 2005 to 2017, Eurolab. 2017 (www.eurolab.org/cookbooks)
  • V. Barwick (Ed), Guide to quality in analytical chemistry: An aid to accreditation, 3rd Edition, Eurachem/CITAC, 2016, ISBN 978-0-948926-32-7 (www.eurachem.org)
  • Accreditation A tool to support regulators, European cooperation for Accreditation of Laboratories, 2016 (www.european-accreditation.org)
  • ILAC-G19:2002, 08/2014, Modules in a forensic science process (www.ilac.org)
  • M. Eleftheriadou, K. C. Tsimillis (Eds), Eurachem guide: Accreditation for laboratories performing microbiological testing, 2nd Edition, Eurachem, 2013 (www.eurachem.org)
  • ILAC G18:04/2010, Guideline for the Formulation of Scopes of Accreditation for Laboratories (www.ilac.org)
  • EA-2/15 M:2008, EA Requirements for the accreditation of flexible scopes, rev 00, July 2008 (www.european-accreditation.org)
  • Guidance on the implementation and management of flexible scopes of accreditation within laboratories, LAB 39, Edition 1, UKAS, 2004 (www.ukas.com)
  • UKAS Guidance on the application of ISO/IEC 17025 dealing with expressions of opinions and interpretations, LAB 13, Edition 2, UKAS, 2001 (www.ukas.com)
  • Quality assurance for research and development and non-routine analysis, Eurachem/CITAC, 1998 (www.eurachem.org) (under revision)

Books

  • B. W. Wenclawiak, M. Koch, E. Hadjicostas, Quality assurance in analytical chemistry: Training and teaching, 2nd Edition, Springer, 2010, ISBN 978 3642136085
  • E Prichard, V Barwick, Quality assurance in analytical chemistry, Wiley, 2007, ISBN 978-0-470-01204-8
  • W. Funk, V. Dammann, G. Donnevert, S. Iannelli, E. Iannelli, Quality Assurance in Analytical Chemistry: Applications in Environmental, Food and Materials Analysis,
    Biotechnology and Medical Engineering, Wiley VCH, 2006, ISBN 978-3527311149
  • D. B. Hibbert, J. J. Golding, Quality assurance in the analytical chemistry laboratory, Oxford University Press, 2006, ISBN 0195162129
  • G. E. Baiulescu, R.-I. Stefan, H. Y. Aboul-Enein, Quality and reliability in analytical chemistry (Analytical Chemistry Series), CRC Press Inc, 2000, ISBN 978 0849323762
  • F. Garfield, M. E. Klesta, J. Hirsch, Quality assurance principles for analytical laboratories, 3rd Edition, AOAC International, 2000, ISBN 0 935584 70 6
  • J. Kenkel, A primer on quality in the analytical laboratory, Lewis Publishers, 1999, ISBN 1 566 70516 9

Articles and reports

Return to reading list >>