Stadium Asia, an established offshore provider of high quality contract electronic manufacturing services (EMS), has achieved a significant manufacturing approval for the medical market at its China manufacturing facility.

The internationally recognised ISO 13485:2003 standard for the manufacture of medical devices was granted following a 12 month programme to develop the Electronic Manufacturing Services (EMS) facilities within the Guangdong Province of China, which now includes a class 10,000 clean room, medical documentation control and fully audited traceability system.

ISO 13485 is a complement to the ISO 9001 Quality, ISO 14001 Environmental and TS16949 Automotive standards already in place and adds considerable value to the Stadium Asia offering in the high reliability and high technology medical sector . Nigel Rogers, Chief Executive said: “This accreditation really demonstrates our commitment to customers in this specialist sector in which high reliability and traceability are critical requirements. We can now offer comprehensive manufacturing support in the medical sector and we will continue to invest in expanding the capabilities of our operations both in the UK and in China to build on our key strengths. We have enhanced both production and staff facilities significantly in the last 12 months and are adding additional surface mount production capacity to both the ems operations this year.”

“Our wholly owned China facility offers direct access to competitive, high volume manufacturing. However, as we continue to develop the knowledge, expertise and capability of the China plant, we are now re-positioning to an offering that includes high technology product, R&D and higher levels of design expertise.

“This latest medical certification is a key step towards future growth in the niche areas such as the medical device market.”

ISO 13485:2003 is an internationally recognised standard that focuses on maintaining product safety, risk management, inspection and traceability, documentation, validation of processes for sterile medical devices, and demonstrates an organisations ability to provide medical devices that consistently meet customer and regulatory requirements.

Stadium Asia provides a full customer-focused turnkey manufacturing service from printed circuit boards to full product build. Stadium Asia employs over 1300 people including significant design and R&D resource and is part of Stadium Group plc.