Obtaining ISO9001 and ISO13485 certification indicates that a company has built a management system that is essential to strengthening the company’s ability to guarantee the quality of medical equipment.
As a manufacturer of medical equipment, we are increasing our efforts to improve customer satisfaction, and our research and development, manufacturing, and sales reflect an emphasis on quality in order to supply products that customers can trust and rely on.
Based on our on-site first (hard facts first) philosophy and the needs of the market, we carry out the development, manufacture, and sales of highly usable products that heighten the level of medical technology. Our aim is to improve customer satisfaction.
By building a production system that integrates sales, manufacturing, and technology, we bring a strong sense of responsibility to our production operations with the aim of providing our customers with high-quality products.
Maintaining a constant awareness of global value, we aim to satisfy our customers by providing high-quality, competitive products.
SO13485：2003 Certification Obtained
ISO13485：2003 is an international standard that was created in order to establish a quality management system for the medical equipment industry throughout the world, and has been or is being incorporated into the laws and regulations of each country.
In Japan as well, the Revised Pharmaceutical Affairs Acts, which took effect in April of 2005, requires that companies that engage in the manufacture and sales of medical equipment, and companies that engage in the import and sales of medical equipment, have in place management practices that accord with the requirements of ISO13485：2003. Daiken Medical developed plans for obtaining ISO13485：2003 certification at an early stage, and was the first in the industry to receive certification for all our offices and factories in October of 2004.
Note: The ISO13485：2003 international standard is based on the ISO9001：2000 international standard for quality management systems and adds special requirements for medical equipment. It was newly issued on July 15, 2003.
ISO9001：2008 Certification Obtained
ISO9001：2008 is an international standard for quality management systems. Daiken Medical obtained ISO9001 certification for all its offices and factories in March of 2004. This demonstrates that our quality management systems, implemented for the purpose of continually improving quality, satisfy international standards.