ArticlePractical laboratory medicine2020
Investigation of the long-term yield of auditing for conformity with the ISO 15189:2012 quality standard in a hospital pathology laboratory.
Article in Practical laboratory medicine, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.
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Who cites it
3 citing papers in PubMed.
- Improving Laboratory Continuous Professional Development Training in Africa: The ASLM Academy Experience.Tropical medicine & international health : TM & IH · 2026Article
- Digital pathology transformation: don't forget the 'soft infrastructure' - a practice-based response from China.Virchows Archiv : an international journal of pathology · 2026Article
- From Establishment to ISO15189:2012 Accreditation: The Case of Hararghe Health Research Laboratory, Harar, Ethiopia.EJIFCC · 2025Article
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Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionPathology laboratories are increasingly seeking accreditation to quality standards to assure Quality of Service (QoS). However, there is little data available regarding the value of this in laboratories with well-established Quality Management Systems (QMS). Moreover, critics of accreditation claim it redirects resources toward trivial issues. Our objective was to investigate the value of auditing for conformity with the ISO 15189:2012 standard in such laboratories.
designand Methods: In total, 483 Audit-Identified Non-Conformities (AINCs) were documented within our department since transitioning to an ISO 15189:2012 compliant QMS. The potential consequences of these were assessed by three clinical laboratorians who assigned them into categories based on their likely impact. These were:
resultsAccording to majority decision: 395 (81.8%) of AINCs were classified
conclusionsOur data suggest auditing for conformity with ISO 15189:2012 standards may be effective in attaining accreditation, but may have diminishing returns in the long-term once the QMS is established, unless there is continual improvement in the audit process to promote better use of resources.
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