First published in November 2019, ISO 35001 is the International Standard for any organization that tests, stores, transports, works with, or disposes of hazardous biological materials.  
With the devastating effects of the COVID-19 pandemic highlighting a clear need for an International Standard to address biological risks among organizations that manage biological materials, ISO 35001 is the right guidance at the right time.  
ISO 35001 uses an approach that will be familiar to users of ISO Management System Standards. It builds on elements adapted from ISO’s occupational health and safety management system standard, ISO 45001, but with emphasis on the unique aspects of biorisk management. The standard, which enables identification, assessment, control, and monitoring of risks associated with hazardous biological material, was developed by the ISO technical committee for clinical laboratory testing and in vitro diagnostic test systems.[1]  
Like all International Standards, ISO 35001 brought together the contributions and consensus of global experts in the field. These are people with real-world experience who bring industry knowledge and an international perspective to standardization. People like Patricia Olinger who is convenor of the working group that took the standard from draft to final publication. She explains that there was a pressing need for ISO 35001, “it's the first standard of its kind specifically designed to help laboratories and other situations involving biohazardous materials protect themselves and their environment.”  Patricia points out that ISO 35001 is based on performance-evaluations and is not a technical document: “it provides a framework or structure for effective program management for both simple and complex biosafety and biosecurity processes and it helps create risk awareness and communication within an organization.”