As an ISO 13485:2016 certified and FDA-registered organization, NPI/Medical maintains a Quality Management System that ensures our customers' stringent requirements are met.
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Quality Department

// Quality Engineering

// Quality Analysis

// Green and Black belt certified inspectors

// Process Engineering

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NPI/Medical's Internal Quality/Process Engineering team provides process validations consisting of:
  • // APQP
  • //  IQ, OQ, PQ
  • //  Low- volume prototype validations
  • //  Process development using scientific injection-molded principles
  • //  FAI (First Article Inspections)
  • //  MSA Studies
  • //  Process capability studies
  • //  FMEA
  • //  Flow charts
  • //  Control plans
Through the use of Advanced Product Quality Planning (APQP) activities, we work with customers’ fixtures, perform inspections, decide on critical-to-quality criteria, advise on packaging needs and much more.

Once a product is approved, we control production using the established control plan, Failure Mode Effects Analysis (FMEA), and tools such as Statistical Process Control (SPC).

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Quality is NEVER Compromised

We feature a fully equipped metrology lab with modern technology to provide full process validations:

  • // ZEISS Contura 700 CMM using CALYPSO software with VAST XT Gold Sensor System
  • // Two optical video probes (Ram Opticals): Omis II 4X8 and Omis II 6X9
  • // Three OGP Smartscopes, two with CMM capabilities and laser capabilities 
  • // Lighthouse Systems Limited SPC light
  • // Measurement software: Automap version 3.0
  • // Minitab
  • // Moisture analyzer
  • // Nikon Profile Projector with software
  • // Prolink Q.C. Calac version 3.0

Tool Room Inspection Equipment

  • // Nikon Profile Projector V-20 A
  • // Micro-Vu 9050A Video Measuring System
  • // Nikon Measurescope 20
  • // Nikon Quadra Check 2000
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NPI Medical