Under the full cooperation of all departments and the support of the company's senior leadership, on the basis of SA9100D quality management system, it took half a year for the introduction and operation of ISO13485:2016 medical device quality management system, and passed the three-day on-site rigorous audit by Bureau Veritas Certification (Beijing) Co. Certification.

In June, we received the electronic version of “ISO13485:2016 Medical Device Quality Management System Certificate” from Bureau Veritas, and in July, we received the written certificate issued by Bureau Veritas.

Scope of Certification: Manufacture and sale of precision components for medical diagnostic equipment (automated blood biochemistry analyzers, automated hematology analyzers) and medical therapeutic equipment (automated blood cell analyzers, surgical microscopes). 

Passing the ISO13485:2016 certification not only proves that New HongJi can continue to provide high-quality products that meet the needs of medical device customers under a quality assurance system, but also demonstrates the company's higher requirements for quality standards of medical products. The successful passing of this ISO13485:2016 certification gives the company more confidence in product quality and safety regulations.

Under the operation of aviation and medical dual system, it also effectively promotes the quality of optical and general industrial products, quality is the honor of the enterprise, and increases customer loyalty to New HongJi products.

In the unstable situation of the international market caused by the trade war between China and the U.S., obtaining the certification of “medical device quality management system” also provides a strong support for the opening of new markets at home and abroad.

The company will continue to refine the management as the basis of security, pragmatic basis to continuously improve the workflow to strengthen internal control, and strive to achieve faster, better and more sustainable development!

It is expected that all the staff of the company will unite around Mr. Li, keep in mind New HongJi's core values of “pragmatism, innovation and change, growth and win-win”, and continue to carry forward the entrepreneurial spirit!