From March 9 to 12, 2020, the TUV South German certification body appointed two experts to conduct a renewal audit of the ISO 9001 and ISO 13485 systems of Sunway Bio, as well as an annual supervisory audit of ISO 11135 sterilization qualification and EU CE certification.

The audit was conducted for the first time during the outbreak, using remote audits. This novel audit method puts forward higher requirements and challenges for the preparation of the traditional face-to-face on-site audit and the coordination and efficiency in the audit.

During the epidemic, the implementation of various epidemic prevention measures is particularly critical. The company's epidemic prevention and control emergency working group actively responded to President Xi's call, precise and orderly solid to promote the resumption of work and production at the same time, quickly during the audit personnel and office area disinfection put forward a specific deployment plan. The scanning of a large amount of data in the remote audit, the guarantee of the stability of the network signal, and the function test of the conference software are also the problems that must be solved in the remote audit. All departments of the company worked together to complete the above work in just four days, ensuring that the entire audit process was carried out in an orderly and effective manner.

During the four-day audit, two experts reviewed 12 departments including system operation, procurement, design and development, inspection, production, equipment management, human resources, and sales. All functional departments of the company actively cooperate to provide the information requirements put forward by the audit team quickly and efficiently, and conduct video communication with the audit experts to answer the questions raised by the experts in detail.

The audit team gave a high evaluation of our company's system operation and quality management level, and highly praised the staff's work attitude and enthusiasm. Finally, the audit team agreed that the system operation of Shuangwei Biological Company met the requirements of the accreditation standards, and no serious non-conformations were found, and successfully passed the annual supervision and audit of this replacement.

This audit, the company's epidemic prevention and control is not lax, the key work does not stop, solid and strong guarantee the successful completion of the audit activities, maintain the effectiveness of the quality system certificate, for the company's rapid and healthy development has laid a solid foundation.