Quality

Injectronics achieved its ISO13485:2003 registration in July 2004 and uses the Quality System ISO 13485:2003 standards to form the basis of our Quality Management System, engineering disciplines, and business management techniques. ISO 13485:2003 is an International Standard based off the ISO 9001 standard with specific enhancements and requirements towards medical devices, Quality Management Systems, and requirements for regulatory purposes. These techniques are applied to all of our products and processes throughout the organization.

Injectronics is registered to ISO14001:2004. Injectronics uses the Quality System ISO14001:2004 standards to form the basis of our Environmental Management System.

Disciplined Approach to Product Validations

• Installation Qualification Protocol (IQ)
• Operational Qualification Protocol (OQ)
• Performance Qualification Protocol (PQ)
• Design for Manufacturing (DFM)
• Design for Assembly (DFA)
• Six Sigma Methodologies
• Prototype Builds
• Tooling FMEA
• Process FMEA
• Process Development
• Control Plans
• Capability Studies
• Customer Input Throughout

Quality Operating System

A comprehensive list of performance measurables such as internal
and external PPM rating, on time delivery rating, and overall
equipment effectiveness (OEE) is tracked against goals on
a monthly basis. When the goals are not met, the cause of
the non conformity is evaluated using the CAPA system.
The CAPA’s are reviewed for effectiveness at subsequent
meetings.