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Data integrity: requirements set in the accreditation standards

  • Kyriacos C. TsimillisEmail author
Practitioner's Report
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Abstract

The requirements for the competence of laboratories are described in two standards, namely ISO/IEC 17025 and ISO 15189. The former applies to all laboratories except medical laboratories where the latter is the most appropriate. The requirements of both standards include specific references to data and other related terms, their protection and integrity. The recently revised ISO/IEC 17025 introduces additional provisions for the control of data and information management compared to those of the 2005 edition. Both standards include provisions for the use of laboratory information management system(s) for the collection, processing, recording, reporting, storage or retrieval of data. ISO 15189 addresses these issues in more detail in order to meet the particular needs of the sector dealing with personal data of the patients. This article presents the requirements for data integrity and the control of relevant components of the management system set by the standards for laboratories as well as for some other conformity assessment bodies of importance for laboratory work, namely reference materials producers (ISO 17034) and proficiency testing providers (ISO/IEC 17043). Some additional regulatory requirements recently implemented are also discussed.

Keywords

Data Information Records Information management Conformity assessment body Laboratory information management system 

Notes

References

  1. 1.
    ISO/IEC 17025 (2017) General requirements for the competence of testing and calibration laboratories. International Organization for Standardization/International Electrotechnical Commission, GenevaGoogle Scholar
  2. 2.
    ISO 15189 (2012) Medical laboratories—requirements for quality and competence. International Organization for Standardization, GenevaGoogle Scholar
  3. 3.
    Tsimillis KC (2018) Measurement uncertainty: requirements set in the accreditation standards. Accred Qual Assur 23:109–114.  https://doi.org/10.1007/s00769-018-1310-3 CrossRefGoogle Scholar
  4. 4.
    ISO 17034 (2016) General requirements for the competence of reference material producers. International Organization for Standardization, GenevaGoogle Scholar
  5. 5.
    ISO/IEC 17043 (2010) Conformity assessment—general requirements for proficiency testing. International Organization for Standardization/International Electrotechnical Commission, GenevaGoogle Scholar
  6. 6.
    Tsimillis KC (2015) Training needs to understand quality assurance. Accred Qual Assur 20:53–59.  https://doi.org/10.1007/s00769-014-1092-1 CrossRefGoogle Scholar
  7. 7.
    ISO 9000 (2015) Quality management systems—fundamentals and vocabulary. International Organization for Standardization, GenevaGoogle Scholar
  8. 8.
    ISO/IEC 17025 (2005) General requirements for the competence of testing and calibration laboratories. International Organization for Standardization/International Electrotechnical Commission, Geneva. Superseded by ISO/IEC 17025 (2017)Google Scholar
  9. 9.
    Barwick V (ed) (2016) Eurachem/CITAC guide: guide to quality in analytical chemistry: an aid to accreditation. www.eurachem.org
  10. 10.
    Eurolab “Cook Book” (2017) Doc No. 13 Technical records. www.eurolab.org/cookbooks.aspx
  11. 11.
    Regulation (EC) No 679/2016 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) OJ L 119/1Google Scholar

Copyright information

© Springer-Verlag GmbH Germany, part of Springer Nature 2019

Authors and Affiliations

  1. 1.Division of Quality AssurancePancyprian Union of ChemistsNicosiaCyprus

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