QUALITY ASSURANCE
Quality Policy
Law-abiding, compliance, sound system, continuous improvement and quality first
Quality Management System
Yonghe-Sun has an independent Quality Management Department, which is composed of a group of professional and technical personnel with comprehensive knowledge, rich experience, excellent technology and strong sense of responsibility. The Quality Management Department has established a strict quality management system in accordance with GMP and ISO13485, and is responsible for monitoring the whole process of raw materials warehousing, production of intermediates and finished products, storage and transportation of finished products. The strict management system ensures the accuracy and reliability of QC data of raw materials, semi-finished products and finished products, and the supervision of the whole product life cycle, ensuring the uniqueness and traceability of each batch of products.
Quality Management System Certifications
GMP certification first in 2006
ISO13485 Quality Management System Certification in 2013
Hunan Quality Credit AA Level Enterprise awarded in 2019
Hunan Quality Credit AAA Level Enterprise awarded in 2021
Traceability = Precision
Quality is the life of IVD products, and accuracy is the "core element" of IVD products. Yonghe-Sun takes "precision" as a commitment and responsibility, and lays the foundation of products by traceability.
IVD is an important reference for clinical diagnosis and treatment, and ensuring the accuracy of test results is the first priority. Metrological traceability (MT) is to verify the whole detection system, including instruments, reagents, calibrators and operating procedures. MT can trace the accuracy of test results back to the highest international reference method or certified reference material, which is the only way to test medical standardization.