Samsung Biologics Obtains International Standard Quality Management System Certification

Samsung Biologics announced on the 7th that it held an award ceremony for the quality management system 'ISO 9001' at its headquarters in Songdo, Incheon. No Gyun, Head of DS Center; Kim Yong-shin, Head of Global Support Center; James Choi, Head of Global Information Marketing Center; Sam McAwhor, Head of Quality Operations Center; Song Kyung-soo, BSI Representative; Keith Ellis, Corporate QA Team Leader; and Lim Seong-hwan, Head of BSI Business Development Division, are posing for a commemorative photo. (Photo by Samsung Biologics)

[Asia Economy Reporter Chunhee Lee] Samsung Biologics announced on the 7th that it held a quality management system 'ISO 9001' award ceremony at its headquarters in Songdo, Incheon.

This event was organized to deliver the ISO 9001 certificate, an international standard for quality management systems from the global certification body British Standards Institution (BSI), to Samsung Biologics. Samsung Biologics obtained the ISO 9001 quality management system certification on the 16th of last month. This standard, established by the International Organization for Standardization (ISO), strictly evaluates whether the quality management system covering the entire process from products to services meets international standard requirements during the audit process.

To achieve this certification, Samsung Biologics formed a dedicated task force (TF) team earlier this year and began preparations for the audit. As a result, within six months, it achieved a flawless record across all currently operating factories (Plants 1 to 3), including contract manufacturing (CMO) and contract development (CDO) business divisions.

Samsung Biologics explained that it received excellent evaluations particularly for operating an 'Enterprise Quality Integrated System' that digitizes the large volume of data generated during the production process according to current Good Manufacturing Practice (cGMP) standards for pharmaceutical manufacturing quality control and transparently shares this data with its clients.

John Rim, President of Samsung Biologics, said, “As a leading global contract development and manufacturing organization (CDMO), obtaining this ISO certification demonstrates our unwavering internal management processes even in crisis situations such as the COVID-19 pandemic.” He added, “We will devote all efforts to ESG (Environmental, Social, and Governance) management, including quality management capabilities, to satisfy stakeholders such as clients and investors.”