First International Standard for biorisk management

Standards Australia

Wednesday, 15 January, 2020

First International Standard for biorisk management

A new International Standard has been published to help enable effective risk management of biohazardous materials, which should result in a reduced chance of accidents, less impact on the environment and a more efficient use of time and other resources.

From diagnosing diseases to pharmaceutical and scientific research, the handling of biological materials in laboratories and elsewhere is essential for many industries but doesn’t come without its dangers; such materials should therefore be handled in stringent, risk-proof ways. A biorisk management system is a key step towards this as it enables an organisation to effectively identify, control and manage the biosafety or biosecurity risks related to its activities.

ISO 35001, Biorisk management for laboratories and other related organisations, is the 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 that is recognisable everywhere.

“ISO 35001 provides organisations and individuals with a roadmap of how to organise and systematically manage and structure their biological risk programs,” she said.

“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. It is available from Standards Australia or through the ISO Store.

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