COMPLIANCE COMMITMENT

Our partners’ commitment compliance

 

 

•      ISO 14971:2007; EN ISO 14971:2012

•      ISO 13485:2003 Certified Quality Management Systems

•      ISO 11607

•      ISO 9001

•      ISO 14001

•      FDA registered and audited facilities to include the California Food & Drug Branch

•      Directive MDD 93/42/EEC

•      CE Marked Products

•      Japan’s MHLW Ministerial Ordinance No. 169  

QUALITY CONTROL

Quality control, cost reduction, and precision manufacturing

•      ISO Class 7, 8, 9 controlled environments

•      cGMP (current Good manufacturing procedures)

•      5s Methodology

•      Controlled fixtures and gauges; NIST and for our defense customers, MIL SPEC traceable calibrated instruments

•      ASTM standards

•      Kanban inventory systems packaging

•      Just in time shipments for zero inventory costs

•      No cost tooling for qualified orders

•      And for the defense industry, ITAR registration

PARTNER CONTRIBUTIONS

employee and environmental health is key

 

•      Workforce wellness and social responsibility programs

•      Wind energy powered plants

•      Wetland protection

•      Waste reduction management and education