ISO 15189:2022 – Medical Laboratory Accreditation
Ensuring Quality, Competence, and Patient Safety
What is ISO 15189?
ISO 15189:2022 is an international standard that specifies the quality management system (QMS) requirements specific to medical laboratories. It focuses on both the technical competence and the management system essential for delivering accurate and reliable medical laboratory results.
Applicable to: Clinical Biochemistry, Hematology, Immunology, Microbiology, Molecular Diagnostics, Pathology Labs, and other medical diagnostic services.
Key Objectives
- Improve reliability and accuracy of laboratory test results
- Enhance patient safety and quality of care
- Establish internationally accepted laboratory practices
- Demonstrate competence and credibility to clients and regulators
Structure of ISO 15189:2022
- Clause 4: General Requirements (Impartiality, Confidentiality)
- Clause 5: Structural Requirements (Organization & Management)
- Clause 6: Resource Requirements (Personnel, Equipment, Environment)
- Clause 7: Process Requirements (Pre-analytical, Analytical, Post-analytical)
- Clause 8: Management System Requirements (QMS, Internal Audit, Risk Management)
Core Components
- Document Control & SOPs
- Internal & External Quality Control (IQC & EQAS)
- Training & Competency Assessment
- Traceability & Equipment Calibration
- Risk-based Thinking & Continual Improvement
Benefits of ISO 15189 Accreditation
- Improved diagnostic accuracy and consistency
- International recognition of laboratory competence
- Enhanced confidence of clinicians and patients
- Legal and regulatory compliance
- Better risk management and continual improvement
Implementation Tips
- Form a dedicated QMS team
- Perform gap analysis against ISO 15189:2022
- Develop SOPs and training modules
- Conduct internal audits and management reviews
- Engage with NABL (India) or other accreditation bodies
Did You Know? ISO 15189 is harmonized with ISO/IEC 17025 and ISO 9001, promoting a risk-based approach and process orientation.
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