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 15189:2022. 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 supporting 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 19011:2018. Guidelines for auditing management systems (www.iso.org)
• ISO 20658:2023. Requirements for the collection and transport of samples for medical laboratory examinations (iso.org)
• ISO 22367:2020. Medical laboratories – Application of risk management to medical laboratories (iso.org)
• ISO 31000:2018. Risk management — Guidelines (iso.org)
• ISO 35001:2019. Biorisk management for laboratories and other related organisations (and Amendment 1:2024) (iso.org)

Guides

• B. Magnusson, K. C. Tsimillis (Eds), Eurachem guide: Accreditation for laboratories performing microbiological testing (3rd ed. 2023) ISBN 978-91-519-6581-9 (www.eurachem.org)
• Tested & Accepted – Implementing ISO/IEC 17025:2017, United Nations Industrial Development Organisation (UNIDO), 2020 (https://www.unido.org/sites/default/files/files/2020-06/Guide%20ISO%2017025-2017_online.pdf)
• V. Barwick (Ed) Eurachem/CITAC: Guide to quality in analytical chemistry: An aid to accreditation (3^rd ed. 2016). ISBN 978-0-948926-32-7 (www.eurachem.org)
• Quality assurance for research and development and non-routine analysis, Eurachem/CITAC, 1998 (www.eurachem.org)
• EA-2/19 INF:2022, List of risks for accreditation processes and operation of national accreditation bodies (www.european-accreditation.org) 
• EA-2/15 M:2023, EA Requirements for the accreditation of flexible scopes, rev 02, November 2023 (european-accreditation.org)
• EA-4/09 G: 2022, Accreditation for sensory testing laboratories, rev.03, Jun 2022, (www.european-accreditation.org)
• EA-4/20 G (rev.01) 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)
• EA Multilateral Agreement: Facilitating cross border trade with safe and reliable goods and services (2018) (european-accreditation.org)
• UKAS Guidance on the Application of ISO/IEC 17025:2017 Dealing with Expressions of Opinions and Interpretations, LAB 13, Edition 4, UKAS, 2022 (www.ukas.com)
• Accreditation A tool to support regulators, European cooperation for Accreditation of Laboratories, 2021 (www.european-accreditation.org)
• ILAC B9:02/2017, ISO 15189 Medical Laboratory Accreditation (ilac.org)
• ILAC G7:04/2021, Accreditation requirements and operating criteria for horseracing laboratories (www.ilac.org)
• ILAC G18:01/2024 Guideline for describing scopes of accreditation (ilac.org) 
• ILAC G19:06/2022, 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, 2^nd 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, 3^rd 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)
  • 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, revision no. 4, 10/2018
  • Doc No. 7, Management reviews for laboratories, revision no. 3, 09/2018
  • Doc No. 9, Internal audits, revision no. 4, 09/2018
  • Doc No. 10, Internal audits, the auditor, revision no. 3, 09/2018
  • Doc No. 14, Internal audits, audit report, revision no. 4, 10/2018
  • Doc No. 16, Corrective action, revision no. 3, 10/2018
  • Doc No. 18, Risk based approach, based approach, revision no. 4, 04/2021
• AMC Technical Briefs, RSC, (https://www.rsc.org/membership-and-community/connect-with-others/join-scientific-networks/subject-communities/analytical-science-community/amc/technical-briefs/):
  
  • AMC TB 28-2007, Using analytical instruments and systems in a regulated environment

Articles and reports

• K.C.Tsimillis, S.Michael, Accreditation of medical laboratories: What is new in ISO 15189:2022, Accred. Qual. Assur., 2024, 29, 175-182, https://doi.org/10.1007/s00769-024-01576-z

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Last Updated: Saturday, 25 May 2024 22:17

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