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Implementation, and Auditing of a Laboratory Biorisk Management System Based on ISO 35001:2019

This guidance document was developed by the Biorisk Institute (BI) (a not-for-profit organization) in Canada, a partner of Biorisk Management International (BRMI), to help laboratory biorisk professionals become more familiar with the Establishment, Implementation, and Auditing of a Laboratory Biorisk Management System based on ISO 35001:2019

Since successfully implementing and auditing a 35001-based biorisk management system requires an upfront solid knowledge in biosafety and biosecurity, this guidance document is not a rewrite of existing guidelines and information available on laboratory biosafety and biosecurity. Instead, it equips biorisk professionals with the key management system aspects they need to be familiar with, empowering them to engage in implementing, maintaining, and continually improving their institutional BRMS. In addition, practical information on auditing (internal audits) is given.

This publication, a companion document for our ISO 35001:2019 Lead Auditor Course, has been rigorously reviewed by international experts. This review ensured the document’s applicability, accuracy, and relevance, making it a valuable resource for biorisk professionals interested in the next evolution of biorisk management!

One of our concerns is the significant cost of ISO Standards, Technical Specifications, and ISO Guidance documents. For that reason and to promote the implementation of biorisk management systems worldwide, BI has decided to make this publication available to the biorisk management community free of charge.

“The book is incredibly easy and enjoyable to read, with the author’s personality and expertise shining through. Stefan skillfully breaks down the language and requirements of ISO 35001, offering valuable insights—even when he respectfully questions certain elements of the standard. His explanations guide readers on how to navigate and apply the standard effectively. By addressing perceived shortcomings or omissions with clarity, he empowers readers to engage with ISO 35001 in a positive and practical way.“

“This guide provides readers with a fantastic introduction to the components of an ISO-based biorisk management system that they can apply to their organization. It has useful implementation guidance for laboratories, including example plans/documents in the appendices, and it describes what types of documentation or other evidence an auditor may request from the organization to support conformity with those clauses.”

“Stefan has prepared an extremely useful and readable document to help with both implementing and auditing Biorisk Management Systems (BRMS). This document will be invaluable to anyone wishing to either partially or fully implement a biorisk management system, irrespective of prior knowledge about management systems. The templates provided give a clear path forward which is readily accessible. Additional information on how to audit the BRMS will help with both internal and external audits to make the BRMS stronger. This document is a valuable asset to the biorisk community.”

“Biorisk management is critical for ensuring the safety and security in biological research, healthcare laboratories and other facilities. Beyond just compliance with regulations, the implementation guidance document on biorisk management adds significant value understanding more on a systematic approach of biorisk management in an organization.“