Biorisk management

Biorisk management is defined as coordinated activities to direct and control an organisation with regard to biological risk or “biorisk”. These activities include both administrative controls as well as laboratory procedures and practices.

Customer support

Department of Microbiology offers customer support on a daily basis. For questions regarding our analyses, sampling, expert advice you can contact us either by phone, weekdays 9.00–12.00 and 13.00–15.30, or via E-mail.

Phone: +46-10-205 24 44

E-mail to Customer support

The Guidance Tool for Enhancing Biorisk Management in European Laboratories (EBRM-Guidance Tool) This document is intended to serve as a guidance tool for enhancing biorisk management in European containment laboratories. The EBRM-Guidance Tool contains a wide-ranging collection of information to be utilised when establishing or maintaining a laboratory biorisk management system. Such a system is pivotal for laboratory activities that involves various sorts of handling of biological material including transport, transfer and storage of materials that may contain infectious agents. Since the document was drafted within Work Package 7 of the Joint Action SHARP project, the attended use of the EBRM-Guidance Tool is laboratories handling highly infectious agents in risk group 3 and 4. The information in the EBRM-Guidance Tool focuses on essential legislation and provides qualitative guidance that may have an impact on managing biological hazards and threats in facilities handling and storing infectious agents.

The international standard on biorisk management for laboratories

ISO 35001 Biorisk management for laboratories and other related organisations defines a process to identify, assess, control, and monitor the risks associated with hazardous biological materials and is applicable to any laboratory or other organisation that works with, stores, transports, and/or disposes of hazardous biological materials.

ISO 35001:2019 can be used as a tool in internal biosafety audits to identify deficiencies related to biosafety and biosecurity and provide guidance on how these deficiencies can be remedied.

This ISO standard is the result of a global work with broad representation from government agencies, biosafety organisations, research institutes, the biotechnology industry and the EU. The original work was handled in a so-called CEN Workshop Agreement (CWA) and was named CWA 15793.

The laboratory biorisk management system CWA 15793

CWA 15793 is an international management system for managing laboratory biorisks. It is the result of global work with broad representation from public authorities, biosafety organizations, research institutes, the biotechnology industry, and the EU.

The purpose of CWA 15793 is to establish the necessary requirements to be able to control risks associated with the handling or storage and terminal storage of biological agents and toxins in laboratories and other facilities.

CWA 15793 can be used as a tool in a continual improvement process and can be followed during biosafety inspections to identify failings related to laboratory biosafety and biosecurity and how these failings should be rectified.

Web tool (Securing Biorisks)

To facilitate implementation of a biorisk management system within an organization the Public Health Agency of Sweden has developed a web tool for self-assessment of the management of biorisks. The tool is free-of-charge, easily accessed and can be used for self-control as well as for internal and external audit.

The self-assessment follows the structure of CWA 15793 and is based on the following five areas of requirements: Policy, Planning, Implementation and operation, Checking and corrective action and Review. The results from the assessment may be used for the continuous improvement within the organization.

Training courses

Upon request, or if otherwise posted on this web page, the Agency provides training courses on biorisk management. Target groups for these activities are government laboratories, universities / colleges, and international partners. Tailor-made training programs are designed in agreement with the requesting organization. Teaching and training takes the form of lectures, group discussions and practical exercises in the level 2, level 3 or level 4 containment laboratories or as theoretical training programs outside the laboratory facilities.