February 1, 2024

Good News! Hejustamping Passed ISO13485:2016 System Certification Successully

ISO 13485:2016 refers to a medical device quality management system standard developed by the International Organization for Standardization, its full name is ISO 13485:2016 “Medical devices – Quality Management system – requirements of the standard”. Updated in 2016, this standard is an updated version of ISO 13485:2003 and aims to ensure that medical device manufacturers provide safe, effective and compliant products. The standard is based on the global medical device industry standards and is dedicated to improving the safety and quality of the medical device industry, providing new requirements and guidance to support companies in meeting current medical device industry requirements.

As a professional manufacturer of precision stamping parts, Heju Precision has won the trust and support of many customers over the years by producing high-quality medical parts such as pacemaker shell, blood sugar puncture needle, venous indwelling needle, surgical forceps and so on. With the continuous addition and modification of laws and regulations and corresponding policies in the medical industry, and the rigor and particularity of medical device products, the safety requirements of products are getting higher and higher. In order to better serve its customers, the company has been planning the certification of ISO 13485 medical systems since 2021.medical-device-stamping-parts

The application for certification as a key task of Heju Precision 2023, has been highly valued by the company’s management, and has carried out a lot of statistics and training work for international regulations, system difference assessment, system guidance, system upgrade and other related issues, constantly improve the relevant documents, and earnestly implement each key point.ISO13485-system-certification

The certification team conducted a comprehensive review of the quality management system of Heju Precision in accordance with the audit plan and review program on time, conducted document review, on-site inspection and interview, and visited relevant personnel to review the equipment and facilities, internal audit, management review, design and development, procurement, production implementation, monitoring and measurement, improvement measures and other processes. During the interview, the audit team recognized the company’s quality management system, praised the company’s quality management documents complete and updated in a timely manner, excellent design and production capacity, timely traceability and tracking problems, reasonable quality management compliance, etc.

Finally, the on-site conclusion of the Shanghai Enke ai certification reviewer is: “Heju precision meets the certification requirements, can apply for certification”, and successfully obtained the ISO 13485:2016 quality management system certification on October 20. The success of the ISO 13485:2016 system certification is a major milestone in the company’s continuous pursuit of excellent quality management, and it is also an inevitable result oriented.

The ISO 13485:2016 certification is a recognition and incentive for Heju Precision, but also a responsibility and mission. In the future, Heju Precision will strictly implement and practice the requirements of ISO 13485 system, and provide more quality products and services for customers in the medical industry!