“Participation really helped me understand the value of QMS in biotechnology, because it brings good management practices to the organization in conducting regulated field trials.”
Yes. The BQMS Program is available to interested parties in the regulated community who wish to validate their approach to APHIS regulatory compliance for the import, interstate movement, and field release of regulated GE organisms. Interested parties may include any organization involved in biotechnology research and development, including small businesses and academic researchers.
Advantages of voluntarily implementing a BQMS include improving the management of regulated imports, interstate movements and field releases through establishment of document and record control, effective training, and continuous improvement. A BQMS instills a pro-active approach due to the constant monitoring and verification that must take place. Additional value-added advantages include process efficiency and operational continuity and consistency for the research and development of regulated GE organisms.
Compliance assistance provided through the BQMS Program is provided at no expense to participants.
Traditional quality management systems focus on production and process control and continuous improvement. A BQMS adopted by an organization emphasizes the management of research and development processes with a goal of compliance with APHIS regulations for the interstate movement, importation, and environmental release of regulated GE organisms. The BQMS Program Audit Standard integrates principles from quality management systems including the Codex Alimentarius Hazard Analysis Critical Control Point System and ISO 9001:2008.
Send an email to BRS.BQMS@aphis.usda.gov. An Office of Compliance Assistance representative will contact you.
Last Modified: November 1, 2011