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Ensuring Biorisk Management in BSL-3 Labs: Can ISO 35001:2019 Stand Alone?

July 19, 2024

ISO 35001:2019, “Biorisk Management for Laboratories and Other Related Organizations,” was introduced to address the unique challenges of managing biological risks. This standard focuses on establishing, implementing, maintaining, and enhancing biorisk management systems. It aims to identify, evaluate, and mitigate biological hazards, promoting a secure workplace and compliance with regulatory requirements. While it offers a solid foundation for biorisk management across various biosafety levels, its applicability in high-containment environments like BSL-3 labs warrants a closer examination.

Understanding ISO 35001:2019

ISO 35001 provides a universal framework for biorisk management across Biosafety Levels (BSL 1-4). It emphasizes foundational principles but lacks site-specific or technical requirements, especially critical for BSL-3 and BSL-4 facilities.

Applying ISO 35001 to BSL-3 Environments

BSL-3 laboratories handle infectious agents that pose significant health risks. These labs must adhere to stringent safety protocols to prevent accidental exposure and ensure biosecurity. However, ISO 35001’s general guidelines need to be adapted to meet the specific demands of BSL-3 environments.

Example: Risk Assessment Requirements

ISO 35001:2019, Section 6.1.2, mandates that organizations conduct a risk assessment to identify and evaluate risks associated with biological agents. However, it does not specify the methodology—whether a 3×3 or 5×5 matrix should be used or if the assessment should be activity-based or agent-based. The approach to risk assessment can vary widely across countries and organizations, with some methods proving more effective than others. To align with best practices, organizations should consider industry standards, consult with experts, and continuously review and refine their risk assessment processes.

Example: Maintenance of Facilities and Equipment

ISO 35001:2019, Section 7.1.2, requires the maintenance of facilities and equipment to prevent failures and accidents. In BSL-3 environments, this involves specific engineering controls, such as inward-directed airflow and certified biological safety cabinets (BSCs). Mechanical failures, such as airflow reversals, can create hazardous conditions. Therefore, regular certification and proper maintenance of BSCs and HEPA filters are crucial.

Example: Emergency Response Procedures

ISO 35001:2019, Section 8.2.1, mandates the establishment of procedures to respond to emergencies involving biological agents. For BSL-3 facilities, this includes detailed protocols for spill response, training personnel in using personal protective equipment (PPE), and effective decontamination methods. Thorough documentation of incidents and corrective actions ensures ongoing compliance and preparedness.

Certifying to the ISO 35001 Standard

Certification to ISO 35001 signifies a commitment to global biorisk management standards. This involves integrating the standard’s components with various publications, including legislation, standards, and guidelines. The rigor of certification requirements varies, with BSL-3 facilities facing more stringent demands. The expertise of the auditing firm is crucial in this process.

At World BioHazTec, we have been certifying and verifying BSL-3 and BSL-4 facilities for 29 years. Our auditors are experienced practitioners who have contributed to national standards and international guidelines. As recognized certifiers by the Singapore Ministry of Health, we emphasize practical and site-specific solutions for high-containment laboratories.

Take the Next Step in Ensuring BSL-3 Compliance

Ready to enhance your biorisk management systems? Schedule a free 30-minute consultation with our experts at World BioHazTec or email us for more information. Let’s work together to ensure your BSL-3 facility meets the highest standards of safety and security.



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