ISO 35001-2019 PDF

Full title and description

ISO 35001:2019 — Biorisk management for laboratories and other related organisations. This International Standard specifies requirements for establishing, implementing, maintaining and continually improving a biorisk management system to identify, assess, control and monitor risks associated with hazardous biological materials in laboratories and other related organisations.

Abstract

The standard defines a risk‑based process for managing biological hazards across activities such as handling, storage, transport and disposal of hazardous biological materials. It is intended to complement existing laboratory standards and is not intended for laboratories that test for microorganisms/toxins in food or feedstuffs, nor for management of risks from use of genetically modified crops in agriculture.

General information

• Status: Published (current edition; amended).
• Publication date: November 2019 (ISO 35001:2019).
• Publisher: International Organization for Standardization (ISO) — technical committee ISO/TC 212.
• ICS / categories: 03.100.70; 07.100.01; 11.100.01.
• Edition / version: Edition 1 (2019); amended by ISO 35001:2019/Amd 1:2024.
• Number of pages: 26 (main document).

Scope

ISO 35001:2019 applies to any laboratory or organisation that works with, stores, transports and/or disposes of hazardous biological materials and defines a management‑system approach to control biorisks. The standard complements other laboratory standards and provides requirements for risk assessment, containment, personnel competence, incident response and continual improvement; it excludes specific application to food/feed testing and management of genetically modified crops.

Key topics and requirements

• Establishing a biorisk management system (policy, planning, leadership and documented information).
• Risk assessment and risk treatment for hazardous biological materials and associated activities.
• Operational controls: containment, storage, transport, handling and disposal of biological materials.
• Competence, training and personnel health measures.
• Incident preparedness, reporting and corrective action (including lessons learned and communication).
• Monitoring, measurement, internal audit and continual improvement of biorisk performance.
• Integration with other management systems (e.g., quality, occupational health and safety, environmental) and alignment with national/regulatory requirements.
• Consideration of climate‑related impacts and relevant updates introduced by the 2024 amendment (ISO 35001:2019/Amd 1:2024).

Typical use and users

Used by clinical, diagnostic, research and public‑health laboratories, university research groups, biotechnology companies, hospital laboratories, biobanks, biosafety officers, laboratory managers, auditors and regulators seeking a systematic approach to reduce biological risks and demonstrate robust biosafety/biosecurity controls.

Related standards

Complements and may be used alongside ISO/IEC 17025 (testing and calibration laboratories), ISO 15189 (medical laboratories), ISO 45001 (occupational health and safety) and ISO 14001 (environmental management). ISO 35001 evolved from earlier guidance such as CWA 15793 (laboratory biorisk management).

Keywords

biorisk, biosafety, biosecurity, laboratory management, risk assessment, containment, incident response, hazardous biological materials, ISO 35001, training, continual improvement

FAQ

Q: What is this standard?

A: ISO 35001:2019 is an international standard that specifies requirements for a biorisk management system for laboratories and related organisations to identify, assess, control and monitor risks from hazardous biological materials.

Q: What does it cover?

A: It covers establishment and maintenance of a management system addressing policy and leadership, risk assessment and treatment, operational controls (handling, storage, transport, disposal), personnel competence, incident response, monitoring and continual improvement. It is not intended for food/feed testing labs or for risk management of genetically modified crops.

Q: Who typically uses it?

A: Laboratory managers, biosafety officers, research institutes, public‑health and diagnostic laboratories, biotech firms, auditors and regulatory bodies use ISO 35001 to benchmark and improve biorisk management practices.

Q: Is it current or superseded?

A: The standard was published in November 2019 and remains current; it was amended in February 2024 by ISO 35001:2019/Amd 1:2024 (climate action changes). A revision work item (ISO/AWI 35001) is in development for a future edition.

Q: Is it part of a series?

A: ISO 35001 is a standalone International Standard focused on laboratory biorisk management but relates to a suite of laboratory and management‑system standards and builds on previous guidance (for example CWA 15793).

Q: What are the key keywords?

A: Biorisk, biosafety, biosecurity, laboratory, risk assessment, containment, incident response, training, hazardous biological materials, ISO 35001.