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Biorisk management system

SARS, pandemic viruses and threats of the malicious use of pathogens have all woken us up to the risks of biological materials and the need for risk-proof ways of handling them. Hence a biorisk management system as a step towards that as it enables an organisation to identify, control and manage its biosafety or biosecurity risks.

ISO 35001, Biorisk management for laboratories and other related organisations, is a first International Standard for a biorisk management system. It defines the requirements and guidance for laboratories or any other organisation that works with biological agents to control and reduce any risks associated with their use.

Patty Olinger, convenor of the working group that developed the standard, said that while there are a number of regional or national standards that help organisations manage their risks and meet regulatory requirements, ISO 35001 is the first that harmonises them to deliver international best practice, she said.

She said: “ISO 35001 provides organisations and individuals with a roadmap of how to organise and systematically manage and structure their biological risk programmes. This is increasingly important to protect our global public health infrastructure as our world becomes more and more integrated.”

ISO 35001 was developed by ISO technical committee ISO/TC 212, Clinical laboratory testing and in vitro diagnostic test systems.


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