The Eurachem reading list
9. Quality assurance and accreditation
Standards
- 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 (www.iso.org)
- ISO 9004:2018. Quality management – Quality of an organization – Guidance to achieve sustained success (www.iso.org)
- ISO 13485:2016 Medical devices – Quality management systems – Requirements for regulatory purposes (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)
- ISO 15194:2009. In vitro diagnostic medical devices – Measurement of quantities in samples of biological origin – Requirements for certified reference materials and the content of supportin documentation (www.iso.org)
- ISO 15195:2018 Laboratory medicine – Requirements for the competence of calibration laboratories using reference measurement procedures (www.iso.org)
- ISO/IEC 17000:2020. 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)
- ISO 22870:2016. Point-of-care testing (POCT) — Requirements for quality and competenc (www.iso.org)
Guides
- 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/index.php/publications/guides) - M. Eleftheriadou, K. C. Tsimillis (Eds), Eurachem guide: Accreditation for laboratories performing microbiological testing, 2nd Edition, Eurachem, 2013 (www.eurachem.org/index.php/publications/guides)
- Quality assurance for research and development and non-routine analysis, Eurachem/CITAC, 1998 (www.eurachem.org/index.php/publications/guides)
- EA-2/15 M:2019, EA Requirements for the accreditation of flexible scopes, rev 01, April 2019 (www.european-accreditation.org)
- EA-4/20 G (rev.01) Guidance Guidance for the assessment of laboratories against EN ISO 15189 and EN ISO 22870 Point-of Care Testing (POCT) May 2021 (www.european-accreditation.org)
- EA-4/22 G: 2018 EA Guidance on Accreditation of Pesticide Residues Analysis in Food and Feed. Rev. 00, November 2018 (www.european-accreditation.org)
- EA-4/23 INF:2019, EA The Assessment and Accreditation of Opinions and Interpretations using ISO/IEC 17025:2017, rev 01, October 2019 (www.european-accreditation.org)
- UKAS Guidance on the Application of ISO/IEC 17025:2017 Dealing with Expressions of Opinions and Interpretations, LAB 13, Edition 3, UKAS, 2019 (www.ukas.com)
- Accreditation A tool to support regulators, European cooperation for Accreditation of Laboratories, 2021 (www.european-accreditation.org)
- ILAC G18:04/2021, Guidelines for Describing Scopes of Accreditation (www.ilac.org)
- ILAC G19:08/2014, Modules in a forensic science process (www.ilac.org)
- ILAC G26:11/2018, Guidance for the Implementation of a Medical Accreditation Scheme (www.ilac.org)
- ILAC G29:06/2020, Guidelines for harmonization of scopes of ISO/IEC 17025 accreditation of WADA anti-doping laboratories (www.ilac.org)
- UKAS policy and general guidance for the implementation and management of flexible scopes of accreditation (GEN 4), UKAS, 2019 (www.ukas.com)
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
Leaflets
- Eurachem information leaflets (www.eurachem.org/index.php/publications/leaflets)
- ISO/IEC 17025:2017 – A New Accreditation Standard (2018)
- Eurolab cookbooks (https://www.eurolab.org/pubs-cookbooks)
- Doc No. 6, How to assess the competence of staff, 2018
- Doc No. 7, Management reviews for laboratories, 2018
- Doc No. 9, Internal audits, 2018
- Doc No. 10, Internal audits, the auditor, 2018
- Doc No. 14, Internal audits, audit report, 2018
- Doc No. 16, Corrective action, 2018
- Doc No. 18, Risk Based Approach, 2021
- AMC Technical Briefs, RSC (www.rsc.org/Membership/Networking/InterestGroups/Analytical/AMC/TechnicalBriefs.asp):
- AMC TB 28-2007, Using analytical instruments and systems in a regulated environment
- Details
- Category: Reading list
- Last Updated: Wednesday, 02 March 2022 12:52