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

Introduction: Infectious disease outbreaks present significant public health and economic challenges that continue to persist worldwide. Accidental laboratory release or criminal misuse of infectious agents adds to these challenges, underscoring the need for responsible research and adequate biological risk (biorisk) mitigation. Countries such as Armenia that lack comprehensive legal frameworks for biosafety and biosecurity are proactively adopting standards such as International Organization for Standardization (ISO) 35001:2019 to enhance their safety culture and build a strong foundation through a structured Biorisk Management System. This study aimed to evaluate the biorisk management gaps at the Reference Laboratory of Especially Dangerous Pathogens (RLEDP) and implement the necessary steps to achieve ISO 35001:2019 certification. Methods: RLEDP worked with both the Management Systems and Business Consultants to perform a gap analysis of the current situation at RLEDP as it pertains to biorisk management, and with international subject matter experts through the Defense Threat Reduction Agency Biological Threat Reduction Program (BTRP) program to provide guidance and training to assist RLEDP. Results: The gap analysis highlighted areas that needed improvement, such as documentation, risk assessment methodologies, and staff training. The analyses and requirements led to the development and/or finalization of 11 facility-specific documents and the completion of 40 individual training courses for RLEDP staff. This work culminated in the development of a Biorisk Management Plan and ISO 35001:2019 certification. Conclusions: In 2022, RLEDP achieved ISO 35001:2019 certification and passed its first annual audit in 2023, demonstrating its commitment to biosafety and biosecurity. Continuous updates, interdepartmental collaboration, and legislative improvements remain essential for maintaining high standards.