Quality Assurances Activities

Item's Quality System is structured to meet the requirements of ISO 9001:2000, with additional local, national and international standards implemented as appropriate. For example, Item has implemented the applicable requirements of the US FDA Good Manufacturing Practice regulation (21 CFR Part 820). Item has also adopted specific quality improvement initiatives, including:

• Vendor Management Program since 1999 (now part of the Supply Chain Management initiative).

• Statistical Process Control since 1998, whose use has been extended by several productivity improvement projects, both by the Hong Kong Productivity Council and internally.

• Comprehensive Product Testing and Qualification Program, which has been enhanced greatly in 2004 by bringing the new QE Laboratory online, with significant investments in new testing and validation equipment.

• Project Management, as an integral part of Design Control. This is Item's first Six Sigma process improvement project, and is expected to result in more accurate first-time product specifications, decreased project turnaround, and increased customer satisfaction.