ISO 35001-2019-Biorisk Management System

ISO 35001 specifies requirements and provides guidance for a biorisk management system for laboratories and other organizations that work with biological agents and toxins. Its purpose is to enable such organizations to identify, assess, control and monitor the risks associated with hazardous biological materials, integrating both biosafety, the containment principles and practices that prevent unintentional exposure or accidental release, and biosecurity, the protection, control and accountability measures that prevent loss, theft, misuse or intentional release. The standard applies to any organization that handles, stores, transports or disposes of biological agents, including clinical, research, academic, veterinary, agricultural, industrial and public health laboratories, as well as production and diagnostic facilities. Its audience includes laboratory directors, biosafety officers, biorisk managers, technical staff and those responsible for oversight and governance. Following the ISO harmonized high-level structure, it addresses organizational context, leadership and worker engagement, planning, support, operation, performance evaluation and improvement, applying the Plan-Do-Check-Act cycle. Core requirements include establishing a biorisk management policy, performing biorisk assessments, implementing a hierarchy of controls covering elimination, substitution, engineering controls, administrative measures and personal protective equipment, ensuring competence and training, managing inventory and accountability of biological materials, planning for emergencies and incidents, and continually improving performance. ISO 35001 draws on and complements international guidance such as the World Health Organization Laboratory Biosafety Manual and aligns with other management system standards including ISO 9001, ISO 45001 for occupational health and safety, and ISO 31000 for risk management, allowing integration into broader management frameworks. The main benefits are reduced likelihood of laboratory-acquired infections and releases, improved regulatory and stakeholder confidence, stronger safety and security culture, and demonstrable due diligence. Although it contains auditable requirements, ISO 35001 is often implemented as a robust management framework, and organizations may seek independent assessment to demonstrate conformity where required.

Included: 94 ready-to-use, fully editable documents (manual, procedures, forms, records, checklists, guidance and training material).

License: single-organization license; delivered electronically as a ZIP archive.