ISO 35001-2019-Biorisk Management System
ISO 35001-2019-Biorisk Management System
Biosafety and biosecurity held in one framework, from the biorisk assessment through to decontamination and waste.
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Written by practising auditors with 20+ years in the field.
By document type
| Category | Files |
|---|---|
| Manuals | 3 |
| Policies | 4 |
| Procedures & SOPs | 18 |
| Plans & Programmes | 4 |
| Forms & Records | 48 |
| Checklists & Audit Tools | 8 |
| Training & Awareness | 4 |
| Guides & Work Instructions | 5 |
Key documents
| Reference | Document | Format |
|---|---|---|
| QM-BRMS-01 | Quality Manual | Word |
| E-BRMS-03 | Biorisk Management Plan | Word |
| E-BRMS-10 | Emergency Preparedness & Response Plan | Word |
| E-BRMS-01 | Biorisk Management Policy | Word |
| PRO-BRMS-01 | Procedure for Risk Assessment | Word |
| PRO-BRMS-12 | Procedure for Decontamination and Waste Management | Word |
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Overview
ISO 35001:2019 specifies requirements and gives guidance for a biorisk management system in laboratories and other organisations that work with biological agents and toxins. It holds two disciplines together: biosafety, the containment principles and practices that prevent unintentional exposure or accidental release, and biosecurity, the protection, control and accountability measures that prevent loss, theft, misuse or intentional release. It applies wherever biological agents are handled, stored, transported or disposed of — clinical, research, academic, veterinary, agricultural, industrial and public health laboratories, and production and diagnostic facilities.
The system follows the ISO harmonised high-level structure — context, leadership and worker engagement, planning, support, operation, performance evaluation and improvement — under Plan-Do-Check-Act. Its operational core is the biorisk assessment and the hierarchy of controls that follows from it: elimination, substitution, engineering controls, administrative measures and personal protective equipment. Around it sit competence and training, inventory and accountability for biological materials, personnel reliability, decontamination and emergency planning. The content draws on the World Health Organization Laboratory Biosafety Manual and aligns with ISO 9001, ISO 45001 and ISO 31000. ISO 35001 carries auditable requirements, and independent assessment can be sought where a regulator, funder or customer expects it.
What this system covers
- Biorisk assessment — agents, procedures and exposure routes identified, evaluated and treated
- Hierarchy of controls — elimination, substitution, engineering, administrative measures and PPE
- Containment and biosafety levels — facility practice, inspections and daily laboratory checks
- Biosecurity and personnel reliability — access approval, vetting and sensitive information
- Inventory and accountability — receipt, storage, transfer and disposal of biological materials
- Decontamination and waste — methods, waste streams and verification of effectiveness
- Emergency preparedness — contingency planning, incidents and transport emergency response
- Equipment and physical security — maintenance, calibration, validation and security checks
Who it's for
Biosafety officers, biorisk managers, laboratory directors and the quality staff supporting them in facilities handling infectious material. The purchase is usually prompted by a regulator, funder, accreditation body or institutional biosafety committee asking for a documented biorisk management system, or by a new or upgraded containment facility coming into use. You end with a stated biorisk policy, procedures assessed and controlled, staff trained and vetted, and inspections, drills and inventories recorded where an assessor will look.
Everything you get
Every toolkit gives you a full set of working documents for your standard, ready to edit and use.
Native Microsoft files. Add your logo and adapt every document to how you work.
Your full toolkit arrives as a ZIP the moment payment clears.
One purchase covers everyone in your organisation. No per-seat fees.
Built by people who run real audits, so the content matches what assessors check.
One payment, perpetual licence for your organisation. No subscriptions, no renewals.
Full refund if your files are faulty, incomplete or not as described and we can't put it right
Frequently asked questions
What exactly do I receive?
A downloadable ZIP containing the full set of ready-to-use documents for this toolkit — manuals, procedures, forms, records, checklists, guidance and training material, all in editable Word and Excel format. The exact document count is shown at the top of this page.
Are the documents really editable?
Yes. Every file is native Microsoft Word or Excel — no locked PDFs. Add your logo, change wording, and tailor the content to your organisation. The toolkit is yours to keep and reuse.
Does this certify my organisation?
No. These are documentation toolkits aligned to the relevant standard to help you prepare. Certification itself is issued by an accredited certification body after their audit. Our toolkits give you a strong, audit-ready starting point.
How is it delivered?
Instantly and digitally. There's no physical shipment — you download the files right after payment and receive a backup link by email.
Do I get updates?
Yes. If we revise this toolkit, you're entitled to the updated version at no extra cost — just contact us with your order details.
What is your refund policy?
These are digital products, so once a toolkit has been downloaded we cannot take it back. If you have not downloaded yet, contact us and we will cancel the order and refund you in full. We also refund in full if the files are damaged, incomplete, or not what the product page described.
Cannot find your standard?
Tell us which scheme you work to. We will point you to the right toolkit.
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