February 25, 2011
Fortune 500 in the world-Emerson passed ISO13485 on-site audit
On February 23, 2011, Emerson, a Fortune 500 company, successfully passed the ISO 13485 on-site audit by the Hong Kong Quality Assurance Agency (HKQAA) under the guidance of TQM.
Emerson’s Computer Products Asia-Pacific Co. Ltd. has a very high reputation in Hong Kong. They are the winners of the Hong Kong Government’s Productivity Award and Quality Award in 1992.
ISO13485 is the high end of the medical equipment quality management system. Obtaining ISO13485 certification is also the only way to enter the medical equipment market. To implement the ISO13485 project, the most difficult one is the need to analyze and evaluate all potential risks in the life cycle of medical equipment in accordance with the ISO14971 standard, and take effective measures to reduce these potential risks to an acceptable level. Many companies, and even consulting companies, stay away.
The TQM advisory team and the relevant person in charge of Emerson use FMEA, “fishbone analysis” and other tools in accordance with the ISO14971 standard to analyze the functions, performance, components, production processes, equipment use, maintenance, and even equipment recycling and disassembly Various aspects have carried out item-by-item, repeated analysis, evaluation, and improvement of control measures for potential risks. Finally, with the joint efforts of everyone, an “EMERSON Medical Equipment Risk Management Report” was completed to the satisfaction of the HKQAA audit team.