Overview
EN ISO 22367:2026 – Medical laboratories – Application of risk management to medical laboratories – provides a structured approach for identifying and managing risks associated with medical laboratory examinations. Developed by CEN and aligned with ISO guidelines, this international standard is relevant for all processes in a medical laboratory, including pre-examination, examination, and post-examination phases. Its main objective is to minimize patient harm and enhance patient care by implementing effective risk management processes.
By harmonizing with established management systems such as ISO 15189, EN ISO 22367:2026 ensures that medical laboratories introduce proactive and systematic risk management activities into their quality systems. This standard does not prescribe acceptable levels of risk, nor does it cover risks from clinical decisions made after examination results are reported.
Key Topics
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Comprehensive Risk Management Process
- Identification, estimation, evaluation, control, and monitoring of risks throughout all laboratory activities
- Integration into laboratory quality management in accordance with ISO 15189 requirements
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Stakeholder Protection
- Focus on reducing risks to patients, laboratory staff, and service providers
- Addresses risks associated with laboratory procedures, equipment, information systems, and reporting
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Scope of Risk Management
- Applies to all examination processes: from sample collection (pre-examination), through testing (examination), to result transmission (post-examination)
- Includes technical and managerial processes influencing examination accuracy and safety
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Proactive vs. Reactive Risk Management
- Encourages laboratories to implement both proactive (preventative) and reactive (incident-driven) approaches
- Emphasizes proactive planning and continuous improvement
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Integration with Other Risk Systems
- Complements enterprise-level risk management frameworks, such as ISO 31000, by focusing specifically on risks unique to medical laboratory operations
Applications
Practical application of EN ISO 22367:2026 in a medical laboratory environment enhances patient safety, operational reliability, and service quality. Typical implementations include:
- Risk Assessment in Laboratory Processes
- Routine evaluation of workflow steps to identify potential hazards, such as sample mislabeling or equipment failure
- Quality Control and Improvement
- Systematic monitoring and documentation of control measures within the context of existing laboratory quality systems
- Result Verification and Data Integrity
- Ensuring accurate transmission of examination results to electronic health records and stakeholders
- Staff Training and Competency
- Assigning risk management responsibilities and providing ongoing training for laboratory staff
- Regulatory Compliance and Accreditation
- Supporting compliance with accreditation standards (like ISO 15189) and national regulations through robust documentation and risk management records
- Continuous Monitoring and Improvement
- Ongoing surveillance for internal and external sources of risk information, audits, and nonconformity management
Related Standards
For an integrated risk and quality management system, laboratories should consider the following related ISO and CEN standards:
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ISO 15189 – Medical laboratories – Requirements for quality and competence
(Defines overall quality management requirements; EN ISO 22367:2026 aligns risk management processes with these requirements.)
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ISO 31000 – Risk management – Guidelines
(Provides general principles for managing business, legal, and regulatory risks, which are complemented, not replaced, by EN ISO 22367:2026.)
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ISO 14971 – Medical devices – Application of risk management to medical devices
(Shares concepts and frameworks particularly relevant for laboratories using or developing in vitro diagnostic devices.)
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ISO 15190 – Medical laboratories – Requirements for safety
(Guides safety audits and supports integration of risk management with operational safety.)
Implementing EN ISO 22367:2026 fortifies laboratories against clinical and operational risks, ensuring compliance, patient safety, and continuous quality improvement in the dynamic field of laboratory medicine.