标准简介
ISO 15189:2022 是医学实验室质量和能力要求的国际标准，第四版于 2022 年 12 月发布。该标准为医学实验室建立了质量管理体系和评估技术能力的要求框架，涵盖从样本采集前到检验后结果报告的整个检验过程。ISO 15189 是医学实验室认可的全球参考标准，被 70 多个国家的认可机构采纳。该标准基于 ISO/IEC 17025（实验室通用要求）和 ISO 9001（质量管理）的原则，但专门针对医学实验室的独特需求进行了定制。
ISO 15189:2022 版的主要变化包括采用了与其他 ISO 标准一致的高级结构、引入了基于风险的思维方法、增强了对信息管理系统和实验室信息系统（LIS）的要求，以及加强了对患者安全和临床有效性的关注。标准要求实验室具备合格的人员、适当的设施和环境条件、经过验证的检测方法、可溯源的测量设备、以及确保检验前和检验后过程质量的程序。认可由各国认可机构（如中国 CNAS、英国 UKAS、美国 A2LA/CAP）执行，通常每 4 年进行一次完整评审周期。ISO 15189 认可在很多国家已成为临床实验室运营的强制或准强制要求。
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.