Overview

The accreditation standard for medical laboratories. The fourth edition, ISO 15189:2022, replaces ISO 15189:2012 and also replaces ISO 22870:2016, bringing point-of-care testing into the main standard and aligning its structure with ISO/IEC 17025:2017.

ISO 15189:2022, Medical laboratories — Requirements for quality and competence, is the standard medical and clinical laboratories are accredited against. It is the fourth edition, published in December 2022. It cancels and replaces ISO 15189:2012 and also replaces ISO 22870:2016, the separate standard that previously covered point-of-care testing.

The 2022 edition was restructured to align with ISO/IEC 17025:2017, the general laboratory competence standard. Technical and resource requirements come first and management system requirements appear at the end, which reverses the emphasis of the 2012 edition. Risk-based thinking runs through the standard, and the requirements are written around the patient rather than the sample: patient safety and wellbeing are explicit priorities, and requirements address the impact of laboratory activity on patient care.

The requirements cover general matters of impartiality and confidentiality; structural and governance requirements including the laboratory's legal identity, management responsibility and defined activities; resource requirements covering personnel competence, facilities and environmental conditions, equipment, equipment calibration and metrological traceability, reagents and consumables, and externally provided products and services; and process requirements covering the full examination workflow.

That workflow is where the standard's clinical character shows. Pre-examination processes cover information for patients and users, request forms, primary sample collection and handling, transport, receipt and pre-examination storage — the phase where most laboratory errors originate. Examination processes cover verification and validation of examination methods, measurement uncertainty, biological reference intervals and clinical decision limits, documentation of procedures, and ensuring the validity of results through internal quality control and participation in interlaboratory comparison or external quality assessment. Post-examination processes cover reporting of results, including required report content, review and authorisation before release, revision of released reports, and the handling and communication of critical results requiring immediate action.

Point-of-care testing is now integral rather than an add-on. Because POCT is performed outside the core laboratory, often by clinical staff, the standard sets requirements for its governance, training and competence, quality control, and the laboratory's oversight responsibility — a common area of finding during assessment.

Conformity is demonstrated through accreditation by a national accreditation body rather than through management system certification. Assessment is technical: assessors review the examination methods within the requested scope, verification and validation records, uncertainty estimates, internal quality control and external quality assessment performance, and staff competence. In many countries accreditation to ISO 15189 is a condition of reimbursement or of participation in national screening and diagnostic programmes, and the World Health Organization promotes it as a means of strengthening laboratory systems.

Laboratories transitioning from ISO 15189:2012 typically find the work concentrated in restructuring documentation to the new clause order, formalising risk management, evidencing patient-focused requirements, and bringing previously separate POCT arrangements under the single system.

Purpose

To specify requirements for quality and competence in medical laboratories, for use by laboratories in developing their management systems and assessing their own competence, and by laboratory users, regulatory authorities and accreditation bodies in confirming or recognising that competence.

Key Benefits

• Provides internationally recognised accreditation for medical laboratory competence
• Covers the full examination workflow from request and sample collection through to reporting
• Brings point-of-care testing into a single standard with core laboratory activities
• Aligned structurally with ISO/IEC 17025:2017 for laboratories operating both
• Requires validated methods, measurement uncertainty and defined reference intervals
• Requires internal quality control and participation in external quality assessment
• Sets explicit requirements for identifying and communicating critical results
• Frequently a condition of reimbursement or participation in national diagnostic programmes
• Focuses requirements on patient safety and the clinical impact of laboratory activity

Key Requirements

• Maintain impartiality and confidentiality of patient and user information
• Establish legal identity, management responsibility and a defined scope of laboratory activities
• Manage risks to laboratory activities and identify opportunities for improvement
• Ensure personnel competence, authorisation, training and continuing education, with records
• Control facilities and environmental conditions, including storage and staff facilities
• Control equipment, including calibration, maintenance, adverse incident reporting and records
• Establish metrological traceability of measurement results
• Control reagents and consumables, including acceptance testing and inventory records
• Control externally provided products and services, including referral laboratories and consultants
• Manage pre-examination processes: user information, request forms, collection, transport, receipt and storage
• Verify and validate examination methods and determine measurement uncertainty
• Establish biological reference intervals and clinical decision limits and review them
• Document examination procedures and ensure they are available to personnel
• Ensure validity of results through internal quality control and interlaboratory comparison
• Manage post-examination processes: result reporting, review and authorisation, and revision of reports
• Define and manage the handling and communication of critical results
• Govern point-of-care testing, including competence, quality control and laboratory oversight
• Manage complaints, nonconforming work, continuity and emergency preparedness
• Control data and information management including laboratory information systems
• Conduct internal audits and management reviews and act on nonconformities

Who Needs This Standard?

Hospital and clinical laboratories, pathology and diagnostic services, blood transfusion and haematology laboratories, microbiology and molecular diagnostics laboratories, genetics laboratories, private and reference laboratories, and services managing point-of-care testing across wards, clinics and primary care. It concerns laboratory directors and quality managers, biomedical scientists, POCT coordinators, and the accreditation bodies and health authorities that assess them.

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