ISO 15189:2022 PDF

Overview

ISO 15189:2022 - Medical laboratories - Requirements for quality and competence specifies requirements for the quality management and technical competence of medical laboratories. The fourth edition updates comprehensive expectations for governance, processes and resources used to deliver reliable diagnostic information. The standard applies to routine laboratories and point-of-care testing (POCT) and supports assessment, accreditation and recognition by laboratory users, regulatory authorities and accreditation bodies.

Key topics and technical requirements

ISO 15189:2022 covers both management system and technical elements. Major areas include:

• General requirements: impartiality, confidentiality and patient-related responsibilities.
• Structural and governance: legal entity, laboratory director roles, delegation, advisory activities and defined authority.
• Risk management and policies: objectives, quality policy and risk-based approaches.
• Resource requirements: personnel competence, authorization, continuing education and personnel records.
• Facilities and environmental controls: sample collection areas, storage and personnel facilities.
• Equipment and metrology: equipment acceptance, maintenance, adverse incident reporting, calibration and metrological traceability of measurement results.
• Reagents and consumables: receipt, storage, acceptance testing, inventory and incident reporting.
• Externally provided services: referral laboratory oversight, supplier review and service agreements (including POCT operators).
• Process requirements: pre-examination (sample collection, transport, receipt), examination (method verification and validation, measurement uncertainty, clinical decision limits, documentation) and post-examination (reporting, sample retention).
• Quality control and nonconforming work: corrective actions and investigation.
• Information management: data control, system responsibilities, downtime planning and off-site management.
• Complaints, continuity and emergency preparedness.
• Management system documentation and requirements for monitoring, internal audits and improvement.

Practical applications

ISO 15189:2022 is used to:

• Design and implement a laboratory quality management system tailored to clinical testing.
• Guide method verification/validation and ensure traceable, clinically relevant results.
• Build POCT oversight programs and integrate POCT into laboratory governance.
• Prepare for accreditation assessments and satisfy regulatory requirements.
• Improve patient safety through robust sample handling, reporting and confidentiality controls.
• Manage suppliers, equipment lifecycle and calibration programs to maintain measurement confidence.

Who should use ISO 15189:2022

• Clinical/medical laboratory directors and managers
• Quality and compliance teams in healthcare laboratories
• POCT coordinators and clinical service providers
• Accreditation bodies, regulators and laboratory assessors
• Procurement and biomedical engineering responsible for calibration and maintenance

Related standards

• ISO/IEC 17025 (general laboratory competence)
• ISO 9001 (quality management systems) These standards are often used together to align laboratory quality, technical competence and organizational management.

Keywords: ISO 15189:2022, medical laboratories, quality and competence, laboratory accreditation, POCT, metrological traceability, management system, method validation, measurement uncertainty.