The company successfully passed the CE annual supervision and audit
On March 10th, the international certification body TüV SüD dispatched an audit team composed of three audit experts to Beijing Kelian Shenghua. According to ISO13485:2012 standard and MDD directive 93/42/EEC, the company’s quality management system and products Conducted an on-site audit. With the full cooperation of the company's senior management and various departments, the company successfully passed the on-site audit by the expert group. The difference from previous years is that this year Beijing Kelian Shenghua accepted this audit as a representative of an enterprise with excellent quality management system operation. For this reason, the structure of audit experts sent by TüV SüD is also higher than the previous year, and it has specially sent this audit. The person in charge of the Greater China region of the organization personally visited our company's audit site. It can be seen that C&T Shenghua has a certain influence on the company directory of the third-party auditing agency. For our audited companies, it is not only the third-party agency’s recognition of us, but also our pursuit of higher management goals. Progressive ladder. The experts of the audit team audited the company's quality management system in strict accordance with relevant standards, and the audit scope covered the company's relevant functional departments and production assembly workshops. The experts of the audit team learned about the operation of the company's quality system through actual site surveys and inspection of relevant materials and records, and conducted a strict review of the implementation and control of the quality system and the implementation of corrective and preventive measures. The experts of the audit team unanimously confirmed that: 1. The quality management system of Beijing Kelian Shenghua is operating normally and effectively; 2. The product meets the requirements of the CE standard and agrees to continue to maintain the registration of the CE certificate. During the one-day intensive audit process, the audit team fully affirmed and highly evaluated the overall operation status and level of the company's quality management system, and at the same time put forward pertinent suggestions on the continuous and effective operation of the company's management system, and contributed to the company's quality management. The continuous improvement of the system and the continuous improvement of the management level provide assistance. Company representatives said that they would strengthen the training and understanding of certification standards for all employees, increase system execution, and strengthen the supervision of managers, so as to continuously improve the efficiency of the company's quality management work and product quality.
Audit experts make audit arrangements
Audit experts carefully audit
Audit experts carefully audit
Beijing Kelian Shenghua Medical Technology Co., Ltd 京ICP備05070151號 互聯(lián)網(wǎng)藥品信息服務(wù)資格證書號：（京）-非經(jīng)營性-2017-0043