BS ISO 35001-2019 + A1-2024 PDF

Full title and description

BS ISO 35001:2019 + A1:2024 — Biorisk management for laboratories and other related organisations. This British adoption of ISO 35001:2019 specifies requirements and guidance for establishing, implementing, maintaining and continually improving a biorisk management system (BRMS) to identify, assess, control and monitor risks associated with hazardous biological materials used, stored, transported or disposed of by laboratories and related organisations. Amendment A1:2024 adds climate‑action related changes to the original 2019 text.

Abstract

This standard defines a management‑system approach to biorisk that is compatible with other ISO management system standards. It covers the processes and controls needed to manage biological hazards across laboratory operations and related activities while noting specific exclusions (for example, routine food/feed testing and agricultural GMO management). The 2024 amendment introduces climate‑action considerations relevant to biorisk management.

General information

• Status: Published (British adoption of ISO 35001:2019 with Amendment 1:2024).
• Publication date: Original ISO text published November 2019; Amendment 1 published February 2024 (A1:2024).
• Publisher: British Standards Institution (BSI) — as BS ISO — (original international standard published by ISO).
• ICS / categories: 03.100.70; 07.100.01; 11.100.01 (laboratory/clinical/health-related ICS codes).
• Edition / version: Edition 1 (2019) with Amendment 1 (2024) — often shown as BS ISO 35001:2019 + A1:2024.
• Number of pages: Main standard: 26 pages; Amendment 1 (A1:2024): 1 page.

Scope

ISO/BS ISO 35001 specifies a framework for a biorisk management system applicable to any organisation that works with, stores, transports and/or disposes of hazardous biological materials — including clinical, research and diagnostic laboratories, and other relevant facilities. It is intended to complement existing laboratory standards and management systems; it does not apply to routine food/feed microbiology testing or to the management of risks from genetically modified crops in agriculture. The 2024 amendment updates the standard to address climate‑related considerations relevant to biorisk.

Key topics and requirements

• Establishing and maintaining a documented biorisk management system (BRMS) aligned with management‑system principles.
• Leadership, governance and assignment of roles, responsibilities and authorities for biorisk.
• Risk identification, assessment, mitigation and ongoing monitoring of hazardous biological materials and activities.
• Operational controls: containment, engineering and administrative controls, safe handling, transport and waste management.
• Competence, training and awareness for personnel working with biological hazards.
• Incident reporting, investigation, corrective action and continual improvement.
• Monitoring, measurement, internal audit and management review of the BRMS.
• Consideration of external factors and stakeholder needs, including integration with broader safety, quality and occupational health systems.
• Climate action changes introduced in Amendment 1 (A1:2024) — guidance on integrating climate‑related risks and resilience into biorisk management.

Typical use and users

Primary users include clinical, public‑health, research and diagnostic laboratories; biotechnology and pharmaceutical organisations; university and research‑institute laboratories; hospital laboratory departments; biosafety and laboratory managers; quality and compliance officers; and accreditation or regulatory bodies. Training providers, auditors and consultants also use the standard for BRMS implementation and auditing.

Related standards

ISO 35001 is complementary to other management and laboratory standards such as ISO 15189 (medical laboratories), ISO/IEC 17025 (testing and calibration laboratories), ISO 9001 (quality management), ISO 45001 (occupational health and safety), and WHO guidance on laboratory biosafety/biosecurity. The standard was developed to fit alongside existing laboratory standards and systems.

Keywords

biorisk management, BRMS, laboratory biosafety, biosecurity, hazardous biological materials, risk assessment, containment, incident response, competence, continual improvement, climate action, amendment A1:2024.

FAQ

Q: What is this standard?

A: BS ISO 35001:2019 + A1:2024 is the British adoption of ISO 35001:2019 — an international standard for biorisk management in laboratories and related organisations, with Amendment 1 (2024) adding climate‑action related changes.

Q: What does it cover?

A: It covers the establishment, operation and continual improvement of a biorisk management system: identification and assessment of biological hazards, controls (engineering, administrative and PPE), transport and waste considerations, competence and training, incident management and management‑system processes. The amendment provides additional guidance on climate‑related considerations.

Q: Who typically uses it?

A: Clinical, diagnostic, research and public‑health laboratories; universities; biotech and pharma organisations handling biological materials; biosafety officers; quality and compliance staff; auditors and accreditation bodies. Training providers and consultants use it for BRMS implementation and auditing.

Q: Is it current or superseded?

A: The original ISO 35001:2019 remains current and has been amended by ISO 35001:2019/Amd 1:2024 (published February 2024). The standard is subject to periodic review under ISO’s maintenance cycle. Organisations should apply the 2019 text together with Amendment 1 where the amendment has been adopted by the national/BSI publication.

Q: Is it part of a series?

A: ISO 35001 is a standalone management‑system standard focused on biorisk management but is intended to be compatible with the family of ISO management‑system standards (for example ISO 9001, ISO 45001) and to sit alongside laboratory standards such as ISO 15189 and ISO/IEC 17025. Work related to future revisions or work items (e.g., AWI developments) may be underway through ISO technical committees.

Q: What are the key keywords?

A: Biorisk management, BRMS, laboratory biosafety, biosecurity, hazardous biological materials, risk assessment, containment, climate action, amendment A1:2024.