ISO 15189:2022
Medical laboratories — Requirements for quality and competence
Standard Introduction
ISO 15189:2022 is the international standard specifying requirements for quality and competence in medical laboratories. Published in December 2022 as the fourth edition, it provides the definitive framework for laboratory accreditation worldwide. The standard covers the entire examination process from pre-analytical sample handling through analysis to post-analytical reporting, ensuring reliable results that support clinical decision-making.
The 2022 revision introduces a risk-based approach consistent with other ISO management system standards, enhanced requirements for laboratory information systems, and strengthened focus on patient safety and clinical outcomes. ISO 15189 accreditation is recognized by accreditation bodies worldwide through the International Laboratory Accreditation Cooperation (ILAC) mutual recognition arrangement. The standard is used by clinical laboratories in pathology, hematology, clinical chemistry, microbiology, immunology, and genetics.
Laboratory Quality System
Establishes comprehensive requirements for quality and competence specific to medical laboratories, covering pre-examination, examination, and post-examination processes.
Risk-Based Approach
The 2022 edition introduces an enhanced risk-based approach aligned with ISO 9001 and ISO/IEC 17025, requiring laboratories to identify and manage risks to impartial and valid results.
Patient-Centered Focus
Strengthened emphasis on patient welfare, clinical outcomes, and laboratory contribution to patient care pathways.
list_alt Core Requirements
- Impartiality and confidentiality
- Personnel competence and authorization
- Equipment management and metrological traceability
- Pre-examination process control (sample collection, handling)
- Examination procedures validation and verification
- Post-examination result reporting and interpretation
- Quality management system and continual improvement
- Risk management throughout the examination process
Who Needs to Comply?
Medical laboratories (clinical chemistry, hematology, microbiology, immunology, pathology, genetics, point-of-care testing) seeking accreditation to demonstrate competence and reliable results for patient care.
Key Requirements
Personnel Competence
Ensure laboratory personnel are qualified, trained, and authorized to perform specific examination procedures. Maintain competence records and conduct ongoing competency assessments.
Equipment & Metrological Traceability
Calibrate and maintain equipment, ensure metrological traceability of measurement results to SI units or certified reference materials, and validate measurement uncertainty.
Examination Process Validation
Validate or verify all examination procedures before use. Establish measurement uncertainty for quantitative examination procedures and define clinically relevant performance specifications.
Quality Assurance Program
Implement internal quality control and participate in external quality assessment (proficiency testing) programs. Monitor and evaluate the quality of examination results systematically.
Pre- and Post-Examination Processes
Control sample collection, transport, and preparation. Ensure accurate, timely, and clinically useful reporting of results with appropriate reference intervals and interpretive comments.
Penalties & Enforcement
No direct legal penalties — ISO 15189 is a voluntary accreditation standard. However, many national health systems and regulatory bodies require ISO 15189 accreditation for laboratory services. Loss of accreditation can result in inability to provide services to hospitals and healthcare systems.