National foreword

This Published Document is the UK implementation of ISO/TS 5441:2024.

The UK participation in its preparation was entrusted to Technical Committee CH/212, IVDs.

A list of organizations represented on this committee can be obtained on request to its committee manager.

Contractual and legal considerations

This publication has been prepared in good faith, however no representation, warranty, assurance or undertaking (express or implied) is or will be made, and no responsibility or liability is or will be accepted by BSI in relation to the adequacy, accuracy, completeness or reasonableness of this publication. All and any such responsibility and liability is expressly disclaimed to the full extent permitted by the law.

This publication is provided as is, and is to be used at the recipient’s own risk.

The recipient is advised to consider seeking professional guidance with respect to its use of this publication.

This publication is not intended to constitute a contract. Users are responsible for its correct application.

This publication is not to be regarded as a British Standard.

Compliance with a Published Document cannot confer immunity from legal obligations.

This Published Document was published under the authority of the Standards Policy and Strategy Committee on 31 May 2024.

Foreword

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This document was prepared by Technical Committee ISO/TC 212, Clinical laboratory testing and in vitro diagnostic test systems.

Any feedback or questions on this document should be directed to the user’s national standards body. A complete listing of these bodies can be found at www.iso.org/members.html.

Introduction

Principal factors in managing biorisks include, but are not limited to:

establishing and maintaining comprehensive biorisk management;
ensuring that there is qualified and competent advice and support for biorisk management.

Biorisk management advisors are competent individuals who provide advice, guidance, and assurance to the senior management of an organization on issues related to biorisk management.

Examples of biorisk management advisors can include biosafety professionals, biological safety officers, biosafety practitioners, biosafety coordinators, biosafety responsible officials, biosafety advisors, biosecurity officers, policy makers, employers (managers), contractors, consultants, trainers who provide a basis for curricular and learning objectives, recruitment requirements and assurance, and other individuals involved in biorisk management. Competence in biorisk management, within regular biosafety and biosecurity programmes, consisting of respective knowledge, skills and experience, is needed for an advisor to identify, assess, control, and monitor the risks associated with biological materials. Biorisk management competency is specified in this document, relating but not limited to ISO 35001.

This document is applicable to any laboratory or other related organization that handles, stores, transports, and disposes of hazardous biological materials, regardless of the type or size of the facility and biological materials used, where management has identified either the need for biorisk management advice or support or both. It also provides a framework for biorisk management advisors to demonstrate competence in biosafety and biosecurity and to identify areas for biorisk management competence development.

1 Scope

This document defines the requirements for competence of individuals who provide advice, guidance, and assurance on processes to identify, assess, control, and monitor the risks associated with hazardous biological materials in a laboratory or other related organization that handles, stores, transports, or disposes of biological materials that can be potentially hazardous for people, animals, plants and the environment.

2 Normative references

3 Terms and definitions

4 Context for biorisk management advice

5 Functions of biorisk management advisor(s)

6 Biorisk management advisor knowledge, skills, and experience

7 Competence

7.1 General prerequisites

7.2 Range and subject matter of competencies

7.3 Competencies relevant for specific work areas

7.4 Competence documentation including continuing professional development

Bibliography

PD ISO/TS 5441:2024

Competence requirements for biorisk management advisors

Current

Published:

31 May 2024