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Quality Assurance

In choosing IIMAK contract manufacturing services, you can be assured of consistent, high quality products.  Our expereinced staff in operations and quality control engages a full array of statistical tools to assure that all products are produced to the customer's specifications.  Our ISO-08 clean room follows stringent guidelines to protect your product with 34 air changes per hour, and Class 1,000 laminar flow work stations.

Quality Analysis

  • Full lot tracking/traceability
  • Control plans
  • Test plans
  • PFMEA
  • Cpk
  • AQL standard inspections
  • Pareto analysis
  • DPPM measurements

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Certifications

  • ISO 13485 certified
  • ISO-08 clean room
  • Class 1,000 laminar flow work stations
  • ISO 9001:2008
  • QSR & cGMP compliant
  • FDA registered
  • Intertek certified