Quality Management System

Our system, technology, and expertise ensure top-quality parts

A passion for reliable, repeatable quality is built into Profile’s DNA. Our drive for continuous improvement predates 1979, when we installed the very first CNC trimming machine in the thermoforming industry.

Our engineering team leverages expertise as well as technology to maintain high levels of service, confidence, and customer satisfaction.  We frequently engage in early supplier involvement (ESI) techniques as a framework to establish quality parameters.

Certification & Compliance

Our ISO 9001:2015 Certification highlights how we meet demanding quality requirements to meet and outperform your expectations.

The Profile quality team works within ISO standards to provide robust quality documentation that helps ensure process consistency and final part compliance. We first acquired ISO 9001 certification in 2007.

What’s the difference between ISO 9001 vs 13485? Find your answers here.

Our quality management system is specific to thermoforming. Additional compliances include:

  • RoHS
  • REACH
  • FDA
  • UL Recognized fabricator since 1983

Quality Management Systems for Medical Pressure Formed plastic partsQuality Lab 

Visiting customers can see our QC technologies firsthand. Our investment in precision equipment helps our highly trained quality team to ensure consistent final product, part-to-part and run-to-run.

  • Computer controlled multi-axis Hexagon CMM for part measuring
  • Faro arm CMM with laser scanning capability for dimensional analysis
  • Ultrasonic thickness gauges
  • Color spectrophotometer for color monitoring

Analysis

We provide in-house analysis for fast turnaround and capability studies adapted to each customer’s needs and requirements.

Our inspection and measurement capabilities include:

  • First Article Inspection Reports (FAIR)
  • Production Part Approval Process (PPAP)
  • Process Capability Analysis (Cpk)

Looking for a full explanation of these quality requirements? Read the discussion in this article.

The Profile quality system was developed to support our commitment to you: we produce and deliver only the highest quality parts for your new products. Beyond documentation, validation, and industry standards, we work to ensure your satisfaction. Precision and reliability you can trust.

Interested in working with us on a project?