Overview
ISO 22367:2026 – Medical Laboratories: Application of Risk Management to Medical Laboratories is an international standard developed by the International Organization for Standardization (ISO). This standard provides a robust framework for medical laboratories to systematically identify and manage risks associated with laboratory examinations. The overall goal is to enhance patient and worker safety by addressing potential hazards in the pre-examination, examination, and post-examination phases, as well as related technical and management processes.
By following ISO 22367:2026, laboratories can proactively recognize, evaluate, control, and monitor risks to reduce the likelihood of errors, incidents, and adverse events. The standard builds upon the risk management principles found in ISO 31000, specifically adapting these best practices for the unique setting and requirements of medical laboratories. ISO 22367:2026 complements related laboratory quality standards such as ISO 15189, ensuring integrated and effective laboratory management.
Key Topics
ISO 22367:2026 covers essential risk management topics tailored to medical laboratories:
- Risk Management Process: Provides a structured procedure for identifying, estimating, evaluating, controlling, and monitoring risks throughout laboratory operations.
- Responsibility and Competence: Clarifies management’s role in risk oversight and the qualifications required for personnel involved in risk management activities.
- Proactive vs. Reactive Management: Differentiates between proactive risk planning (anticipating and preventing potential hazards) and reactive approaches (responding to incidents or near-misses).
- Documentation and Reporting: Details documentation requirements for risk management plans, analysis, evaluations, and risk control measures.
- Risk Analysis Tools: Introduces methods for hazard identification, risk estimation (likelihood and severity), and benefit-risk analysis.
- Risk Control Measures: Outlines options for reducing or eliminating risks, including the use of laboratory equipment, IVD medical devices, and process modifications.
- Residual Risk and Review: Covers the evaluation of risks remaining after controls are implemented and the importance of regular risk management review and monitoring.
Applications
ISO 22367:2026 is applicable to all medical laboratories, regardless of size, discipline, or scope of services. Key practical applications include:
- Quality and Patient Safety: Systematically reducing the risk of diagnostic errors, adverse events, and delays in results reporting enhances confidence in laboratory services and bolsters patient safety initiatives.
- Continuous Improvement: Ongoing risk assessment and monitoring support a culture of quality improvement in laboratories, aligning with international accreditation requirements.
- Integration with Electronic Medical Records (EMR): Ensures the secure and accurate transmission of laboratory results into EMRs, addressing risks in data management and information security.
- Compliance and Accreditation: Supports laboratories in achieving and maintaining compliance with ISO 15189 and other regulatory requirements by embedding risk management in routine operations.
- Staff Protection: Identifies occupational risks and ensures the implementation of protective measures for laboratory workers.
- Collaboration with IVD Manufacturers: Facilitates shared risk management responsibilities when laboratories use or develop in vitro diagnostic devices, leveraging frameworks similar to ISO 14971.
Related Standards
Medical laboratories implementing ISO 22367:2026 may also be interested in the following related standards to ensure a comprehensive risk and quality management system:
- ISO 15189 – Medical laboratories – Requirements for quality and competence: Core standard for laboratory quality management systems.
- ISO 31000 – Risk management – Guidelines: Provides general principles and guidelines for managing risks in organizations.
- ISO 14971 – Application of risk management to medical devices: Pertinent to laboratories developing or using in vitro diagnostic (IVD) devices.
- ISO 15190 – Medical laboratories – Requirements for safety: Focuses on laboratory health and safety management.
By adopting ISO 22367:2026, medical laboratories can systematically enhance risk management, improve service quality, ensure regulatory compliance, and protect both patients and staff, thereby contributing to higher standards in healthcare diagnostics.
