ISO 15189:2022 — A Complete Overview for Medical Laboratory Directors

ISO 15189:2022 is the current international standard for quality and competence in medical laboratories. Published by the International Organization for Standardization (ISO) in December 2022, it replaces ISO 15189:2012.

ISO 15189:2022 defines the requirements for quality and competence specific to medical laboratories. It is the basis for NABL accreditation of medical laboratories in India and is used by accreditation bodies worldwide.

Structure of ISO 15189:2022

The standard is organized into two main sections:

Part 1: General Requirements

• Clause 1: Scope
• Clause 4: General Requirements (impartiality, confidentiality)
• Clause 5: Structural Requirements
• Clause 6: Resource Requirements (personnel, facilities, equipment)
• Clause 7: Process Requirements (pre-analytical, analytical, post-analytical)
• Clause 8: Management System Requirements (QMS, risk, internal audit, CAPA)

Key Principles of ISO 15189:2022

• Competence: Every person performing testing must be demonstrably competent
• Impartiality: Lab results must be free from bias and commercial pressure
• Risk-based thinking: Proactive identification and management of risks
• Patient focus: The patient is the ultimate beneficiary of laboratory quality
• Continual improvement: Ongoing evaluation and enhancement of QMS

ISO 15189:2022 vs ISO/IEC 17025:2017

While both standards cover laboratory competence, ISO 15189 is specifically for medical laboratories and includes patient-specific requirements. ISO/IEC 17025 is for testing and calibration laboratories in general (industrial, environmental, food, etc.). Medical laboratories should use ISO 15189; if you run a general testing lab, use ISO 17025.