ISO/WD 35001

Laboratory biorisk management system — Requirements ISO/WD 35001

Scope

The scope of this laboratory biorisk management system agreement is to set requirements necessary to control risks associated with the handling or storage and disposal of biological agents and toxins in laboratories and facilities.
This CWA will enable organizations to:
a) establish and maintain a biorisk management system to control or minimize risk to acceptable levels in relation to employees, the community and others as well as the environment which could be directly or indirectly exposed to biological agents or toxins;
b) provide assurance that the requirements are in place and implemented effectively;
c) seek and achieve certification or verification of the biorisk management system by an independent third party;
d) provide a framework that can be used as the basis for training and raising awareness of laboratory biosafety and laboratory biosecurity guidelines and best practices within the scientific community.

This CWA is performance-based and sets out requirements for and places responsibility on organizations to demonstrate that appropriate and validated risk reduction procedures have been established and implemented.
This agreement is structured in a manner where the specific requirements pertaining to each individual clause are defined and stated in a frame-box. Informative guidance has been provided as an aid in interpreting the requirements where considered appropriate. This guidance is in the form of notes in association with the pertaining requirements clause and uses the terms "should" (recommendation), "may" (allowance) and "can" (possibility). Organizations wishing to implement this CWA would be expected to consider all recommendations where the term "should" is used.
Contents of the notes shall not in any way be construed as being requirements.