On September 18, 2025, Boerjing achieved GB/T 42061-2022 / ISO 13485:2016 medical-device quality management system certification for the first time. The certified scope covers the production of plastic parts for medical devices. The certificate number is MSC25MQ10006R0S. The certified organization named on the certificate is Changzhou Boerjing Machinery Co., Ltd.
ISO 13485 is an internationally recognized quality management system standard for the medical-device industry. It places particular emphasis on product-realization processes, risk control, documented records, process validation, traceability and continual improvement. Achieving this certification represents an important step in the development of Boerjing’s quality management system for medical precision injection molding.
Before achieving ISO 13485 certification, Boerjing obtained IATF 16949:2016 quality management system certification in January 2025. Its certified scope covers the production of plastic products, including bearing cages and polyurethane bearing seals. The addition of ISO 13485:2016 certification extends the company’s quality management systems to the production of plastic parts for medical devices.
During the implementation and certification process, Boerjing further reviewed and standardized procedures relating to customer requirements and technical reviews, raw-material and supplier management, mold development, precision injection molding, process inspection, nonconforming-product control, documented records and product traceability.
Boerjing provides custom mold development and precision injection-molding services for medical-device customers. Relevant products include biopsy forceps handle components, snare handle components, medical connectors, custom guide components and other medical precision injection-molded parts. Products are developed according to customer drawings, approved samples and project-specific requirements, with materials, dimensions, tolerances, inspection methods and packaging confirmed during technical review.
Through the continued operation of its IATF 16949:2016 and ISO 13485:2016 quality management systems, Boerjing will continue improving production processes, inspection controls, documented records and product traceability for both plastic bearing components and medical precision injection-molded components.