MicroGroup, part of TE Connectivity, has a certified Quality Management System in accordance with the requirements of ISO 13485:2016.

Process management is the foundation of the MicroGroup QMS. The key processes operating at MicroGroup are described in operating procedures. These documents, supplemented with the quality policy, work instructions, forms, and standards, describe in detail the functioning of the MicroGroup’s QMS. Implementation of these key processes ensures that MicroGroup consistently meets the quality and performance requirements of customers in a timely, effective manner while ensuring traceability for each part.

two women sitting at machines two women standing at machines

For component and assembly manufacturing, MicroGroup evaluates and controls process risks through its quality planning and production control systems, including:

  • Contract review
  • Component supplier management
  • Creation of product specific quality records

Measurement Capabilities

  • Gage, hand tools
    • Calibrated, traceable to National Institute of Standards and Technology (NIST)
  • First article inspection of purchased components
  • Receiving inspection
  • Job inspection
    • First piece set up inspection
    • In process inspection
    • Final inspection
    • Samples sizes developed per C=0 AQL levels and dimension tolerance

Advanced Measurement Capabilities

  • Non Contact Measurement Systems
    • High Resolution Video Measurement Systems
      • OGP Smartscope
        • MeasurMind 3D MultiSensor Software
        • Development of component specific inspection programs by trained in house quality technicians
      • Starrett
      • Onyx
      • Optical Comparator
    • Consistent measurement accuracy

Process Analysis Capability

  • First article Inspection of New Components
  • Tooling/Process Capability Studies
    • Provide level of confidence in process to meet established specifications
  • Gauges have completed gage repeatability/reproducibility (GRR) studies
  • Statistical Analysis
  • Customer Specific Process Validation
    • Includes Installation Qualification (IQ), Operational Qualification (OQ) and Process Performance Qualification (PQ)
    • Verify that equipment and process will consistently produce product that meets predetermined specifications and quality attributes
  • Process Risk Management
    • Process Failure and Risk Analysis
    • Evaluation of manufacturing process by cross functional teams

ISO 13485:2003