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SK bioscience Achieves ISO 27001 Certification

2023.02.07

-SK bioscience acquires ISO 27001 following successful completion of audit on 114 management items in 14 categories

- L-HOUSE, its vaccine manufacturing plant, secures global competitiveness with multiple international certifications including ISO 14001

-“We will expand our business by strengthening the global capabilities


*Photo caption*

(From left) Soyoung Lee, Management Representative of DNV Business Assurance Korea, and Jae-seon Hwang, Head of Digital Innovation Office, SK bioscience pose at ISO 27001 Certificate Awarding Ceremony at SK bioscience headquarters in Seongnam, S. Korea on Feb 6, 2023.

SK bioscience, a global innovative vaccine and biotech company committed to promoting human health from prevention to cure across the globe, announced today that the company has obtained ISO 27001 certification, the most prestigious international standard on information security management. The certificate awarding ceremony was held at the company’s headquarters in Seongnam on February 6th.

ISO 27001 is an international standard for Information Security Management System (ISMS), originally published jointly by the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC).

To be ISO 27001 certified, a company must pass rigorous reviews on 114 management items in 14 categories including managerial, physical, technical, and IT security management conducted by the authority agency designated by the ISO.

SK bioscience successfully passed the audit by the DNV Business Assurance, a world-leading certification agency, in November 2022 after preparing for the certification evaluation over six months in accordance with the high-quality guidelines required by the European Union´s General Data Protection Regulation (GDPR).

SK bioscience is certified in Information Security Management System related to manufacture and GMP of pharmaceuticals at its headquarters in Seongnam and its manufacturing plant L-HOUSE in Andong.

The company explained that obtaining ISO 27001 certification proves the company’s world-class information security system and safe environments for pharmaceutical manufacturing, research, and development. Furthermore, it contributes to gaining trust from global partners and expanding business opportunities, as it is a critical issue in the CMO/CDMO business how to manage and protect sensitive data of the business partners such as intellectual assets and product-related information.

SK bioscience has maintained its efforts to to secure its competitiveness beyond global standards.

The company’s manufacturing plant L-HOUSE in Andong, boasting the world’s best facilities and large scale, has acquired OHSAS 18001 and KOSHA 18001 certifications for occupational health and safety management systems in 2016, followed by ISO 14001 certification for an environmental management system in November 2022. These international certifications help the L-HOUSE to establish itself as a global hub for vaccine manufacturing.

The L-HOUSE has also achieved the Gold level certification for Leadership in Energy and Environmental Design (LEED), the most widely used green building rating system, for the first time among the global pharmaceutical plants.

In addition, the L-HOUSE has secured the continued strength in high-quality product manufacturing that meet the global standard by obtaining the Korea Good Manufacturing Practice (KGMP) in 2014, followed by the EU-GMP in 2020 for the first time among Korea’s vaccine production sites.

Jaeyong Ahn, CEO of SK bioscience said, “We are constantly striving to strengthen the capabilities that meet the global standard and enhance our credibility as a trusted global business partner by obtaining international standard certifications,” adding, “We will further expand our business with global partners and become a top-tier company in the global vaccine and bio industry."