Chinese manufacturer gains ISO accreditation
An offshore provider of high quality contract electronic manufacturing services in China has gained international accreditation to offer manufacturing support to the medical sector.
Stadium Asia has achieved ISO 13485:2003 standard for the manufacture of medical devices. The award follows a 12-month programme to develop the Electronic Manufacturing Services (EMS) facilities within the Guangdong Province of China, which includes a class 10,000 cleanroom, medical documentation control and fully audited traceability system.
The accreditation is a complement to the ISO 9001 Quality, ISO 14001 Environmental and TS16949 Automotive standards already in place and adds value to the Stadium Asia. The standard focuses on maintaining product safety, risk management, inspection and traceability, documentation, validation of processes for sterile medical devices.
Nigel Rogers, chief executive, said: “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.”
He added: “This latest medical certification is a key step towards future growth in the niche areas such as the medical device market.”