About ISO 35001 – An introduction into the biorisk management standard

ISO 35001 – An introduction into the biorisk management standard

Instructor: Toon De Kesel

The ISO 35001 standard on “Biorisk management for laboratories and other related organisations - is the first internationally recognized management standard to specifically address hazards associated with laboratories where biological materials are handled at all containment levels. It sets out the requirements for a management system to enable organizations to effectively identify, monitor, and control risk associated with laboratory biosafety and biosecurity.  It also provides a structured approach to managing risk associated with people, facilities and working procedures in laboratory environments.

The Biorisk management standard is a compendium of all biosafety and biosecurity issues irrespectively of actual laws or administrative provisions. It defines key requirements encompassing all relevant laws and does not focus on the application of individual pieces of legislation. Therefore, the ISO 35001 standard is deliberately general in order to accommodate national differences.

The ISO 35001 webinar aims to help you understand the fundamentals of the standard and how it can be applied to your organization. It will present the principles of biorisk management, identify the multiple components of a biorisk programme and explore ways to integrate them into the management system(s) in place or to be developed in an institution.

Main Topics

The course participants will be able to

  • Identify the fundamentals of a biorisk management system
  • Understand the scope and intend of the ISO 35001 standard
  • Understand the requirements, covering e.g. key roles and responsibilities, biorisk assessment, good microbiological techniques, healthcare, personal protection, emergency planning, biosecurity
  • Initiate or improve the implementation of the standard for their organisation

CWA Reference

The learning objectives are in line with CWA 16335:2011 on the Biosafety Professional, specifically with the CWA clause 7.2.17., “The biosafety professional shall be able to develop and support the implementation of a biorisk management programme and understand how the elements (e.g. physical, personal and informational biosecurity measures) in such a programme are interrelated so as to achieve the objectives of the programme. The biosafety professional shall be able to understand and apply the core principles and practices associated with a management system approach that incorporates continual improvement and be able to communicate them.”

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