Samsung Biologics adds to global ISO certifications with Quality Management System

08 December 2021 | Wednesday | News

- Samsung Biologics earns ISO9001 for Quality Management System, proving its capabilities to ensure high-quality service offerings throughout a product life-cycle - The company is fully certified with the recognition across all of its CDO, CMO and all other core business units in Plant 1,2, and 3
Samsung Biologics ISO9001 Certificate Awarding Ceremony

Samsung Biologics ISO9001 Certificate Awarding Ceremony

Samsung Biologics (KRX: 207940.KS), the world's leading contract development and manufacturing organization, held an award ceremony with the British Standard Institution at its Songdo headquarters for global ISO9001 certification in recognition of the company's Quality Management System. The attainment of this certificate reaffirms Samsung Biologics' capabilities to ensure high-quality service offerings across all value chains for a product life cycle, further enhancing its operational excellence for clients and ultimately offer improved patient outcomes.

"Achieving an ISO 9001 certification is a critical milestone in our journey to building a quality driven organization in everything we do. Our services and products improves the healthcare of nations and, literally, saves lives. Our commitments to our clients and to the patients they serve are a foundation for every employee at Samsung Biologics. This certification is an additional testament that we will always look for ways to improve our quality systems to support our business and its purpose the best we can" Sam Machour, Senior Vice President & Chief Quality Officer of Samsung Biologics, said in a statement.

By meeting the comprehensive set of requirements for the global certification, Samsung Biologics demonstrated its Quality Management System to be in full conformance to ISO 9001:2015 requirements in addition to cGMP regulations across all of the company's CMO (Drug Substance/Drug Product/small-scale Drug Substance) and CDO business units in its entire facilities. With the certification, the company is expected to further offer quality-oriented processes across all functions within the organization.

"We are extremely proud to be adding another global ISO certification to our facility during a time where a high-degree of quality management system is vital to safely supply biomedicines to patients," said John Rim, CEO of Samsung Biologics. "Through this certification, we will be able to further operate under an optimized and compliant management system in which we can build a more sustainable value chain for our stakeholders, clients, and partners, and ensure a stable supply of highest quality products." 

Recently in August this year, Samsung Biologics obtained four global ISO certifications: ISO22301 (Business Continuity Management), ISO50001 (Energy Management), ISO45001 (Occupational Health and Safety Management), and ISO14001 (Effective Environmental Management) to its facility, further advancing both its internal and external capabilities to stably operate and withstand any market fluctuations while maximizing client satisfaction and fulfilling its social responsibilities.


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