ISO 35001:2019
Biorisk management for laboratories and other related organisations
Standard Introduction
ISO 35001:2019 is an active standard published by International Organization for Standardization (ISO). It is commonly used across Healthcare, Pharmaceutical, Medical Devices, Food & Beverage, Education and applies in Global.
Use this page to review the official documentation, current status, and the certification or assessment bodies most commonly associated with ISO 35001:2019.
Hazardous Biological Materials
Provides a management system approach for organizations that work with, store, transport, or dispose of hazardous biological materials.
Biorisk Assessment
Requires systematic identification, assessment, control, and monitoring of biosafety and biosecurity risks across laboratory activities.
Emergency Readiness
Connects containment controls, personnel competence, inventory management, incident response, and continual improvement into a repeatable biorisk program.
list_alt Biorisk Management Themes
- Biosafety and biosecurity risk assessment
- Hazardous biological material inventory control
- Facility, equipment, and containment controls
- Personnel competence and authorization
- Transport, storage, and disposal procedures
- Incident response and emergency preparedness
- Monitoring, internal review, and continual improvement
Who Needs to Comply?
Research, diagnostic, public health, academic, pharmaceutical, biotechnology, veterinary, and industrial laboratories that handle hazardous biological materials or operate in environments where biosafety and biosecurity failures could harm people, animals, plants, or the environment.
Key Requirements
Biorisk Policy and Scope
Define the laboratory activities, materials, sites, personnel, and interfaces covered by the biorisk management system, with leadership accountability and documented objectives.
Risk Assessment and Controls
Identify hazards and assess biosafety and biosecurity risks, then select containment, access, operational, decontamination, transport, and disposal controls proportionate to those risks.
Competence and Authorization
Ensure workers, visitors, contractors, and support personnel are trained, competent, supervised, and authorized for the biological materials and activities they handle.
Inventory and Material Control
Maintain accurate records for hazardous biological materials, including acquisition, storage, transfer, use, inactivation, disposal, and loss or theft response.
Incident and Emergency Management
Prepare for exposures, spills, containment failures, missing materials, transport incidents, and other emergencies through response plans, drills, reporting, and corrective actions.
Penalties & Enforcement
ISO 35001 is voluntary, but laboratories remain subject to biosafety, biosecurity, occupational health, transport, environmental, and public health laws. Poor biorisk controls can lead to regulatory enforcement, loss of permits or funding, laboratory shutdowns, incidents, and reputational damage.
Official Documentation
Official PDF for ISO 35001:2019
Official publication or summary for ISO 35001:2019
Official online resource
International Organization for Standardization (ISO) guidance and reference material
Implementation toolkit
Templates, guidance, or companion resources for ISO 35001:2019