標準簡介
ISO 15189:2022 是規定醫學實驗室品質與能力要求的國際標準。該標準於 2022 年 12 月發布第四版，為全球實驗室認可提供了權威框架。該標準涵蓋從分析前樣本處理、分析過程到分析後報告的整個檢驗流程，確保可靠的結果支持臨床決策。
2022 年修訂版引入了與其他 ISO 管理系統標準一致的基於風險的方法，增強了對實驗室資訊系統的要求，並加強了對病患安全與臨床結果的關注。ISO 15189 認可透過國際實驗室認可合作組織（ILAC）的互認安排在全球認可機構之間獲得承認。該標準被病理學、血液學、臨床化學、微生物學、免疫學和遺傳學等臨床實驗室廣泛使用。
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.