Thistory obtained ISO 9001 certification successfully

ISO 9001 certification

Shenzhen Thistory Bio-Medical Co., Ltd successfully passed the ISO 9001:2015 certification audit and obtained the ISO 9001:2015 quality management system certification on January 6th, 2022.

At the beginning of its establishment, Thistory attached great importance to the construction of laws and regulations and system. At present, it has established a quality management system covering the requirements of domestic medical device laws and regulations, ISO 9001 standard and ISO 13485 standard. The system runs through the whole process of product life cycle, such as organization management, new product project approval, design and development, production and manufacturing, quality management and after-sales service. Under the guidance of the enterprise's quality policy and quality objectives, we have formulated standardized management requirements and standard operating procedures for each process of product realization, and systematically realized the whole process quality management.

In the process of ISO 9001 on-site certification audit, the audit experts made a comprehensive assessment on the construction and operation of the ISO 9001 quality management system of Thistory, and carefully reviewed the organization management, planning and risk management, working environment and production environment control, design and development control, production and quality control, sales and after-sales service control and other aspects, and spoke highly of it. A good quality management system is an important basis for product quality. Thistory has successfully passed the ISO 9001:2015 certification, realizing the ability and commitment of the enterprise to escort the quality of medical devices according to the high-standard quality management system!

The quality policy of Thistory is: " technology innovation leading, focus on product value creation, and deliver high-quality products and services to users." Based on the relevant national and international medical device regulatory regulations and standards, we will continue to update the advanced quality management system and methods, constantly improve the quality management system, strive to improve the quality management level, adhere to the original intention of scientific and technological innovation, focus on the value creation of products, provide users with high-quality products and services, and provide scientific and technological care for human life and health!