On May 25-26, 2015, Beijing National Medical Device Huaguang Certification Co., Ltd. (CMD) sent experts from the audit team to Beijing Kelian Shenghua to conduct GB/T19001-2008 idt ISO 9001:2008 and YY/T0287-2003 on the company. idt ISO 13485:2003 quality management system audit. With the careful preparation and full cooperation of the company's senior management and various departments, the company successfully passed the on-site audit by the expert group. Audit conclusion: 1. The quality management system is operating effectively. 2. Through the supervision and audit, continue to maintain the GB/T19001-2008 and YY/T0287-2003 quality management system certification.
The experts of the audit team audit the company's quality management system in strict accordance with the standards. The scope of the audit covers the company's relevant functional departments and production workshops. The experts of the audit team go to the site to inspect relevant documents and records to understand the implementation of the company's management system documents, control status, and the implementation of corrective and preventive measures. After strict review by the expert group, no unqualified items were found.
During the two-day audit, the company’s overall operation status and level of the quality management system were fully affirmed and highly evaluated; at the same time, during the audit process, the experts of the audit team also put forward pertinent opinions on the continuous and effective operation of the company’s management system. Suggestions for continuous improvement of the company's quality management system and continuous improvement of the company's quality management level. Company representatives also expressed that they will strengthen the training and understanding of certification standards for all employees, and increase the execution of the system to improve the company's work efficiency and product quality.
