SOURCE: AMAX Information Technologies

AMAX Information Technologies

December 15, 2014 12:16 ET

AMAX Awarded ISO 13485: 2003 Certification

Achieves Highest Standard and Compliance for Manufacturing of x86-Based Medical Devices

FREMONT, CA--(Marketwired - Dec 15, 2014) -  AMAX, a leading manufacturer of High Performance Computing (HPC), dynamic Data Center/Cloud and custom Server Appliance  solutions, continues to differentiate itself for its commitment to manufacturing quality by announcing the addition of ISO: 13485: 2003 certification to its U.S. manufacturing operations. This ISO standard specifies the requirements for high quality management systems in designing and manufacturing medical devices.

The certification was awarded by the International Organization for Standardization (ISO), the world's largest developer and publisher of international standards for the implementation of quality management systems and various other technical and operational procedures. AMAX's ISO 13485:2003 certification covers the design, development, manufacturing, distribution, sales, technical support and service in support of medical device industry. It demonstrates that AMAX has successfully implemented a quality management system that conforms to the world-wide standard for medical device and diagnostic manufacturing. With ISO 13485 certification, AMAX can now serve more customers in the medical device field while providing additional assurance for current customers within this industry. This certification is another milestone in AMAX's commitment to manufacturing the highest quality server and computing products for its global customer base after previously receiving ISO 9001 and ISO 14001 certifications.

"Being a technology leader and setting the highest manufacturing standards to the industry are AMAX's mission and vision," said Jean Shih, President, AMAX. "Our ISO certifications demonstrate that our manufacturing facilities comply with the stringent requirements of various industries including those of the medical industry, and we are committed to continuing to build the level of confidence our customers have in AMAX products and services through our absolute pursuit of the highest standard of quality."

"AMAX was able to achieve certification for the ISO 13485:2003 standard after months of rigorous preparation by various departments," said Danny Haloc, Director of Quality Assurance of AMAX. "Having a well-established quality management system and solid teamwork are essential to attaining this type of certification. The ISO 13485 certification emphasizes meeting regulatory as well as customer requirements, risk management and maintaining effective processes specific to safe design, manufacturing and distribution of medical device components."

AMAX manufacturing facilities have held ISO: 9001 for nearly 2 decades. This was followed by adding ISO 14001 Environmental Management System (EMS) standard certification in 2012 as part of AMAX's "Green Initiative" in an aim to continually improve environmental performance applied to all levels of business operations from an organizational level to the product and service level. The new certifications and equipment bolster AMAX's already industry-leading manufacturing capabilities and truly raise the bar for manufacturing excellence.

About AMAX
AMAX is a trusted leader in Datacenter, HPC and OEM Solutions in North America and has been recognized for many industry awards. Founded in 1979 and headquartered in Fremont, Calif., with locations in China and Ireland to service the APAC and EMEA region, AMAX is an open-architecture manufacturer specializing in innovative and scalable cluster, server and storage products developed for Datacenter, HPC, Cloud and Big Data applications. AMAX's mission is to provide best-in-class engineering, architectural design, manufacturing, global logistics & support to empower customers to solve the most complex computing challenges, handle massive amounts of data and meet product development demands to maintain a competitive advantage. As an Official OCP Solutions Provider, AMAX can build datacenter solutions using both standard and OCP architecture.

Contact Information

  • For more information, contact:
    AMAX Corporate Communications
    Office: 510-651-8886