BIOSTEC Earns Four Major ISO Certifications

Recently, BIOSTEC successfully passed four internationally recognized certifications in quality management, environmental management, and occupational health and safety: ISO 13485:2016 (Medical Device Quality Management System), ISO 9001:2015 (Quality Management System), ISO 14001:2015 (Environmental Management System), and ISO 45001:2018 (Occupational Health and Safety Management System). Achieving these certifications marks that the company’s integrated management system has fully aligned with international advanced standards, laying a solid foundation for sustainable and high-quality development.

As a comprehensive in vitro diagnostics (IVD) service provider integrating R&D, manufacturing, sales, technical support, and after-sales services, BIOSTEC has consistently adhered to the philosophy of “market-oriented, quality-first, innovation-driven.” The successful completion of these certifications reflects the company’s long-term commitment to standardized, systematic, and refined management practices.

ISO 13485 & ISO 9001 Certification:These certifications demonstrate that BIOSTEC has established internationally aligned quality management standards covering the entire product lifecycle—from research and development to production and after-sales service—ensuring the delivery of stable, safe, and high-performance IVD products to customers.

ISO 14001 Certification:This certification confirms that BIOSTEC has implemented a systematic environmental management framework, actively fulfilling its environmental responsibilities while pursuing corporate growth and promoting a green and sustainable development model.

ISO 45001 Certification:This certification highlights BIOSTEC’s strong commitment to employee health and workplace safety. By establishing a comprehensive occupational health and safety management system, the company provides a safer and healthier working environment, reflecting its people-centered corporate values.

The achievement of these four certifications represents an important milestone in BIOSTEC’s development. It not only recognizes the company’s current management capabilities but also serves as a driving force for future progress. Moving forward, BIOSTEC will continue to focus on the specific protein diagnostics field, guided by clinical needs and international standards, strengthening its capabilities and delivering higher-quality products and services to global partners.

About BIOSTEC

BIOSTEC is a professional in vitro diagnostics supplier with integrated capabilities in R&D, manufacturing, sales, technical support, and after-sales services. The company specializes in specific protein diagnostics, particularly in the urinary biomarker testing segment, and is committed to providing accurate and reliable diagnostic solutions for clinical laboratories worldwide.