Our Quality System
Quality First is the discipline embedded in every step of our manufacturing process, because the reliability of a monitoring consumable affects patient safety directly.
Drive defects to zero through the relentless pursuit of single-digit PPM.
- ISO 13485 Quality Management System
- CE Mark
- FDA Compliance
Three Inspection Stages on Every Order
IQC
Incoming inspection of connectors, wires, cables, terminals and accessories. Items checked: appearance, shape, materials, dimension, size and colour, against specifications, drawings and samples.
IPQC
In-process inspection across cutting, stripping, crimping, injection and assembly, using first article inspection, patrol inspection, self inspection, mutual inspection and dynamic inspection throughout the process.
OQC
Outgoing inspection of packing, labels, marks, appearance, dimensions and electrical performance, using micrometer, caliper, electronic scale, hardness tester, microscope and cable testing machine.
The Bench Your Batch Passes Through
Micrometer, caliper, electronic scale, hardness tester, microscope and cable testing machine, used at the stages described above.
Horizontal insertion force test machine on the QC bench, used to verify that a connector mates and holds within specification.
Bench inspection and measurement of assembled parts against drawings.
Electrical performance testing before packing.
Process inspection during assembly.
Questions About Quality
Which quality certifications do you hold
Our quality management system is ISO 13485, and we state compliance with CE Mark and FDA regulations. Certificate copies are sent on request.
How many inspection stages does a product pass
Three - IQC, IPQC and OQC - plus first article inspection at the start of a run.
What is your defect target
Single-digit PPM, working towards zero defects.
Can we audit your factory
Audit requests are welcome; contact us by email or WhatsApp to arrange.
Ask for the Documentation
Tell us the product family and the market you are selling into and we will send the relevant certificates and registration paperwork.