Quality Assurances Activities

Item's Quality System is structured to meet the requirements of ISO 9001, 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 is also in compliance with IECQ QC 080000:2005 by implementing a Hazardous Substance Process Management (HSPM) system in the company. This is an internationally recognized standard which specifies the requirements of product compliance that manufacturers should adopt to ensure that their products conform to new manufacturing limits, including fulfillment of the European Directives for RoHS and WEEE.

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.