Guidance in the application of quality management in the field of chromatography in routine medical laboratories – EFLM Committee: Accreditation and ISO/CEN Standards point of view

Abstract Background Chromatographic separation has become a critical analytical technique in routine laboratory medicine. Although several documents address standardisation in chromatography, they largely focus on industrial and pharmaceutical applications. Routine medical laboratories remain underserved, creating a need for guidance tailored to their specific context. This paper aims to provide technical guidance on applying ISO 15189:2022 requirements to chromatographic methods, ensuring quality and risk management across all laboratory phases. Content Building on previous work of the European Federation of Laboratory Medicine Committee on Accreditation and ISO/CEN Standards, we reviewed ISO 15189:2022 requirements and interpreted them in relation to chromatographic procedures. Key vulnerabilities inherent to chromatography – such as sample preparation variability, column performance drift, and detector calibration – were identified and mapped to relevant quality and competence clauses. Summary and Outlook The guidance highlights chromatography-specific risks and proposes structured verification, documentation, and risk management strategies. It addresses pre-analytical, analytical, and post-analytical phases, emphasizing traceability, method verification, and result of release. Special consideration is given to laboratory-developed tests using chromatographic techniques, aligning them with European in vitro diagnostic regulation. By contextualising ISO 15189:2022 within the technical realities of chromatography, this paper provides laboratories and auditors with practical tools to safeguard quality, reduce uncertainty, and ensure reliable patient results. The proposed framework advances regulatory harmonisation and supports the routine implementation of chromatography in medical laboratories.