ISO/CD TS 7446

ISO 35001 — Biorisk management for laboratories and other related organisations — Implementation guidance

Scope

This ISO Technical Specification provides detailed guidance on the implementation of the biorisk management elements outlined in ISO 35001 “Biorisk management for laboratories and other related organisations.” This document leverages the expired CEN Workshop Agreement 16393:2012 Guidance for the Implementation of CWA 15793:2008. (CEN Workshop Agreement 15793:2011 “Laboratory Biorisk Management” – the basis for ISO 35001). This document is intended to complement existing International Standards for laboratories and related facilities including ISO 35001:2019. Implementation guidance to explain what is written in and support action to materialise ISO 35001 is seriously needed, since risk assessment-based biorisk management system is relatively new to laboratories. For ISO 35001 to be implemented globally, this performance-based standard requires supportive documents providing details of how to conform with it. CWA 15793:2012 and CWA 16393:2012 will be used as a informative references for this work.