Great News: Maixin Company Successfully Passes ISO Dual Certification!
To further standardize production operation procedures, effectively control risks, improve operational efficiency, and establish a standardized and normalized management model, Fuzhou Maixin Biotechnology Development Co., Ltd. began implementing the ISO9001 and ISO13485 quality management systems in 2016, and successfully passed the audit and certification for ISO9001:2008 and ISO13485:2003.
As the first enterprise in China to establish an immunohistochemistry quality control laboratory, Maixin has always held itself to high industry standards. Combining industry characteristics, it actively builds a comprehensive quality management system to promote the standardization and normalization of internal company management. During this certification process, the audit team experts conducted a comprehensive, strict, and detailed review of various aspects of our company, including product research and development, production management, sales system, management responsibilities, resource management, process management, medical device quality and safety, measurement, analysis, and improvement, based on the ISO9001:2008 and ISO13485:2003 certification standards. They confirmed that our quality system operates normally and in compliance, with all aspects under proper control, and gave unanimous praise. Our company successfully passed the audit.
Receiving this ISO dual certification is a high recognition from the International Organization for Standardization for Maixin, demonstrating our strength in quality management and also serving as an encouragement for the hard work of Maixin employees on the path of pursuing excellence and innovation. We believe that the establishment and implementation of this ISO quality management system will not only help improve the company’s quality management level but also lay the foundation for comprehensive scientific management, which is of profound significance for the company’s long-term development and the realization of its corporate vision.
The ISO 9001 Quality Management System is an international standard developed by ISO/Tc176 (the International Organization for Standardization’s Technical Committee on Quality Management and Quality Assurance). It is primarily used to demonstrate that an organization has the capability to provide products that meet customer requirements and applicable regulatory requirements, with the aim of enhancing customer satisfaction. Moreover, third-party certification bodies are not influenced by the economic interests of the producer and seller, ensuring impartiality and scientific rigor. It serves as a universal passport for countries to evaluate and supervise product and enterprise quality; it can be used as a basis for customers to audit a supplier’s quality system; and it proves that the enterprise has the capability to meet the technical requirements of its ordered products. It can be said that the ISO9001 Quality Management System is fundamental to the development and growth of an enterprise, and obtaining ISO9001 certification is essential work for standardizing and continuously improving product and service quality.
However, since medical devices are special products for saving lives, healing the wounded, preventing and treating diseases, their fundamental quality requirements are safety and effectiveness. Relying solely on the general requirements of the ISO9001 standard to regulate medical device manufacturers is insufficient. Therefore, ISO issued the ISO13485 standard, which sets specific requirements for the quality management systems of international medical device manufacturers. It specifies quality system requirements for the design, development, production, and corresponding installation and service of medical devices, used for evaluating medical device quality management systems. It is currently recognized by most countries worldwide as the standard or regulatory requirement for medical device quality management systems and is also one of the necessary conditions for entering their markets. Therefore, establishing and continuously maintaining an effectively operating ISO13485 quality management system is a necessary condition for Maixin to deeply cultivate the medical device market and plays a crucial role in enhancing our company’s future market competitiveness and brand influence.