Stadium Asia achieves medical<br>manufacturing approval

The internationally recognised ISO 13485:2003 standard for the manufacture of medical devices was granted following a 12 month programme to develop the 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 demonstrates our commitment to customers in this specialist sector in which reliability and traceability are critical requirements. We have enhanced both production and staff facilities in the last 12 months and are adding additional surface mount production capacity to both the ems operations this year.” 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.