Overview
ISO 22367:2020 - Medical laboratories - Application of risk management to medical laboratories provides a structured framework for applying risk management across all medical laboratory activities. The standard specifies a process to identify, estimate, evaluate, control and monitor risks that affect patients, laboratory workers and service providers. It applies to pre‑examination, examination and post‑examination processes, including the transmission of test results into electronic medical records. ISO 22367:2020 focuses on laboratory safety and clinical risk related to testing processes; it does not set acceptable risk levels, cover clinical decisions made after reporting, or address enterprise/business risks covered by ISO 31000.
Key Topics and Requirements
- Risk management process: A complete cycle covering risk analysis, risk evaluation, risk control, benefit‑risk analysis, and ongoing monitoring and review.
- Risk analysis and documentation: Identification of hazards, hazardous situations and foreseeable harms; estimation of probability and severity; and documented risk analysis.
- Risk evaluation and acceptability: Establishment of risk acceptability criteria and processes for evaluating whether identified risks require control.
- Risk control and verification: Selection of risk controls (including role of standards and IVD devices), verification of effectiveness, and assessment of residual risk.
- Risk monitoring: Surveillance procedures, internal and external sources of risk information, and immediate actions to reduce risk.
- Quality and competence: Management responsibilities, personnel qualification, and integration of risk management within a laboratory quality management system.
- Supportive guidance: Multiple informative annexes (examples, tools, risk plan guidance, methods for estimating probability/severity, benefit‑risk analysis, residual risk evaluation).
Practical Applications
- Implement a repeatable medical laboratory risk management program to reduce patient harm and operator risk.
- Integrate risk activities into ISO 15189‑based laboratory quality management systems (e.g., complaint handling, internal audit, CAPA).
- Guide IVD device performance risk sharing between manufacturers and laboratories, improving device use and usability.
- Use informative annexes for practical tools: hazard examples, risk assessment techniques, and templates for a risk management plan.
- Support accreditation and regulatory readiness by documenting risk decisions, verification, and monitoring activities.
Who Should Use This Standard
- Clinical laboratory managers and quality/risk managers
- Accreditation bodies and assessors
- In vitro diagnostic (IVD) manufacturers collaborating with laboratories
- Hospital safety officers and laboratory personnel involved in process design and result reporting
- Regulatory and public health authorities focused on laboratory safety and test reliability
Related Standards
- ISO 15189 - Medical laboratories - Requirements for quality and competence (integration with QMS)
- ISO 14971 - Medical devices - Application of risk management to medical devices (aligned concepts)
- ISO 31000 - Risk management - Guidelines (enterprise/business risk, not covered by ISO 22367)
Keywords: ISO 22367:2020, medical laboratory risk management, ISO 15189, ISO 14971, IVD risk, patient safety, laboratory accreditation.
