Biorisk Management
Biorisk management for laboratories and related organisations. Provides requirements for managing biological agents and toxins presenting risks to human, animal, or plant health.
ISO 35001 specifies requirements for biorisk management systems applicable to laboratories and other organisations working with biological agents and toxins that present risks to human, animal, or plant health. It integrates biosafety (protecting personnel and the environment) and biosecurity (protecting biological materials from misuse) within a single management system framework.
The standard applies to clinical, research, diagnostic, environmental, and agricultural laboratories as well as biobanks, vaccine manufacturers, and healthcare facilities. It provides a systematic approach to managing biological risks that complements containment level requirements.
ACI-certified auditors evaluate biorisk management system effectiveness, assess biological risk assessment quality, and review the adequacy of containment and biosecurity controls.
Attend an ACI-Approved Training Provider (ATP) course for your chosen grade level. ACI-approved courses are aligned to the examination syllabus for ISO 35001.
Examinations are administered exclusively through ACI Approved Training Providers. Foundation and Internal Auditor examinations require 70% to pass; Lead Auditor requires 65%.
Submit your application through the ACI portal with your examination result, training certificate, and relevant audit experience log. Upon approval you receive your ACI Card ID and digital certificate.
Available Grades for ISO 35001
All six ACI auditor grades are available for this scheme. Each grade has defined competence, experience, and examination requirements.
Entry-level certification for those beginning their auditing career. Suitable for individuals who have completed foundation training but have limited audit experience.
For auditors who have completed Internal Auditor training and have begun accumulating audit experience under supervision or in an internal audit role.
Full auditor grade for practitioners with demonstrated audit experience. Recognised as a competent independent auditor of management systems.
Senior grade for experienced auditors capable of leading audit teams and managing full audit programmes. The most widely recognised auditor grade internationally.
Advanced grade for highly experienced auditors demonstrating sustained performance in complex audit environments and contributions to the auditing profession.
The highest ACI designation, awarded to individuals who have made an exceptional contribution to the management system auditing profession and to the ACI community.
Find an Approved Training Provider, sit the examination, and submit your application to ACI.