PUBLIC HEALTH PREPAREDNESS & RESPONSE
The What and How of ISO 35001:2019 Biorisk Management for Public Health Labs
By Michael Marsico , senior specialist , Biosafety and Biosecurity
ISO 35001 : Biorisk management for laboratories and other related organisations was first published in November 2019 by the International Organization for Standardization ( ISO ) that outlines a process to identify , assess , control and monitor the risks associated with hazardous biological materials in a laboratory setting . ISO 35001 is for any institution that works with , stores , transports and / or disposes of hazardous biological materials and is intended to complement existing standards or other guidelines for laboratories .
ISO is an independent , non-governmental international organization with a membership of 165 national standards bodies that develop voluntary , consensusbased standards based on global experts ’ opinions . To date , ISO has developed more than 24,000 standards .
ISO 35001 establishes biorisk management principles by applying them in seven different areas :
• Context of the organization
• Leadership
• Planning
• Support
• Operations
• Performance evaluation
• Improvement
Each principle benefits from a systematic approach , which enables an organization to effectively assess , control and evaluate its progress through the Plan-Do- Check-Act ( PDCA ) model . Using the PDCA outlined in the standard , public health laboratories can identify and mitigate the biosafety and biosecurity risks in the workplace to reduce incidents , accidents , infections and illnesses that may result from laboratory operations .
APHL , in collaboration with the
US Centers for Disease Control and Prevention ( CDC ), is developing a strategy to provide guidance for public health laboratories interested in ISO 35001 implementation along with a
free webinar on the values of ISO 35001 implementation . If you would like additional information or have any questions , please email biosafety @ aphl . org . •
24 LAB MATTERS Spring 2022