1. Perfect quality system management

Implement ISO 13485:2016 and ISO 9001:2015 dual quality management system
ISO 9001 quality management system is the core standard among all international standards. ISO 13485:2016 is an international standard established based on ISO 9001 system requirements with specific requirements for the medical device industry;

Our company is the first Chinese enterprise in the industry to pass the ISO 9001:2015 quality management system certification, and passed the ISO 13485:2016 quality management system certification in 2021, and can provide customers with products that are produced and verified under the same specifications and standards. Improve product suitability;

Due to the continuous pursuit of production quality control, our company continues to implement a dual quality management system, carefully controls the entire process of product development, production, distribution, etc., operates in strict accordance with SOP, and continuously optimizes while maintaining high standards and strict requirements. Improve the quality management system, and strive to provide customers with products with small batch-to-batch variation and high stability.

2. Strict production quality control

Professional production - equipped with professional and capable production personnel to strictly implement the production quality management system process to ensure stable product supply

Comprehensive training - Provide comprehensive quality training for product-related R&D, production, and quality personnel, and continuously strengthen quality awareness

Quality Management - Strict supplier selection, consumables procurement process and system management, quality control in the production process to ensure stable and uniform product quality and an effective quality management system in a virtuous cycle

Equipment Calibration - Regular maintenance and calibration of R&D, production, quality testing related equipment and special tools

Continuous improvement - timely follow up on customer feedback on product use, through reason analysis, take corresponding corrective/preventive measures for R&D, production, and quality, and continue to improve

CE marked IVD products - AIVD Biotech

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