What is ISO 35001?
ISO 35001 specifies requirements for a biorisk management system, enabling laboratories and other organisations that work with biological agents and toxins to identify, assess, control and monitor the associated risks to people and the environment.
Published in 2019, it combines biosafety (preventing accidental exposure or release) and biosecurity (preventing loss, theft or misuse) within a single management-system framework that follows the Annex SL high-level structure.
In the UK it is relevant to clinical, diagnostic, academic and industrial laboratories and complements regulatory frameworks overseen by bodies such as the HSE and applicable containment requirements.
How to get ISO 35001 certified
- Identify biological agents and toxins in scope and assess biorisks.
- Establish a biorisk policy with clear roles and a biorisk management committee.
- Implement controls covering containment, training, inventory and incident response.
- Operate the system and maintain detailed records.
- Run internal audits and management review.
- Certify through an accredited body offering ISO 35001 and maintain via surveillance and three-yearly re-certification.
Choosing a certification body
For a certificate to carry weight, choose a body accredited by UKAS, the UK's national accreditation body. Accredited certification is recognised by customers and procurement teams; unaccredited certificates often are not. Get quotes from at least three bodies, as fees vary.
How much does ISO 35001 certification cost?
There is no single price — total cost depends on your organisation's size, how much you already have in place, the number of sites, and whether you use a consultant. Broadly, the cost splits into three parts: implementation (building the system), the certification audit (paid to the certification body), and ongoing costs (annual surveillance and a three-yearly re-certification).
- A specialised standard with a smaller pool of competent auditors, which can raise day-rates.
- Containment, facility and training controls are significant cost drivers outside the audit itself.
- Often implemented alongside laboratory accreditation such as ISO/IEC 17025.
To get a tailored figure for your organisation, use our free calculator:
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