What ISO 35001 is
ISO 35001 is the standard for managing biological risk in laboratories and other facilities that handle dangerous biological materials. It covers safe handling, containment, staff competence and emergency response so that pathogens and toxins stay controlled.
In the US it matters most to clinical, research and biotech labs, especially those working under CDC and NIH biosafety guidance. It gives a structured, auditable way to show a lab manages biorisk properly.
The standard blends biosafety (stopping accidental release) and biosecurity (stopping deliberate misuse) into one management system.
How to get certified
- Assess the biological risks across every process and material you handle.
- Set containment, handling and competence requirements matched to those risks.
- Align the system with CDC/NIH biosafety guidance and any federal select-agent rules.
- Train staff, run the system, and build records of drills and reviews.
- Complete the internal audit and management review, then engage a certification body.
- Pass the audits and maintain through annual surveillance.
Always use an accredited certification body
In the US, look for a body accredited by ANAB. An accredited certificate is the one customers, regulators and buyers actually trust — and you can confirm any certificate through IAF CertSearch.
How much ISO 35001 costs
This is a specialist standard. Fewer certification bodies offer it, so get quotes early.
Physical containment upgrades, if your facility needs them, are a separate and possibly large cost.
Cost scales with the number of labs and the risk level of the agents handled.
Calculate your cost range → Get free quotes →