Implementation of a Biorisk Management System in Armenia for ISO 35001:2019 Certification

Area of Science:

• Public Health
• Laboratory Safety
• International Standards

Background:

• Infectious disease outbreaks pose global public health and economic risks.
• Biological risk (biorisk) mitigation is crucial due to potential laboratory accidents or misuse.
• Armenia is adopting International Organization for Standardization (ISO) 35001:2019 to strengthen biosafety and biosecurity frameworks.

Purpose of the Study:

• To evaluate biorisk management gaps at the Reference Laboratory of Especially Dangerous Pathogens (RLEDP).
• To implement necessary measures for achieving ISO 35001:2019 certification.
• To enhance the laboratory's Biorisk Management System and safety culture.

Main Methods:

• Conducted a gap analysis of current biorisk management practices at RLEDP.
• Collaborated with management consultants and international subject matter experts from the Defense Threat Reduction Agency Biological Threat Reduction Program (BTRP).
• Developed and finalized facility-specific documents and conducted staff training programs.

Main Results:

• Identified key areas for improvement, including documentation, risk assessment, and staff training.
• Developed 11 facility-specific documents and completed 40 training courses for RLEDP staff.
• Established a comprehensive Biorisk Management Plan.

Conclusions:

• RLEDP successfully achieved ISO 35001:2019 certification in 2022 and passed its 2023 annual audit.
• The certification demonstrates a strong commitment to biosafety and biosecurity.
• Sustained high standards require continuous updates, interdepartmental collaboration, and legislative improvements.