KGL Certified to ISO 13485:2016 for Medical Device Components

KGL has been registered to ISO 13485:2016, the quality management standard for medical devices, by certification body NQCC (certificate 50526YY00027R000, valid 15 May 2026 to 14 May 2029). The scope covers precision CNC machining of medical device components.

Why Medical Machining Needs Its Own Standard

ISO 9001 asks whether the process is controlled. ISO 13485 asks whether it is controlled the way a medical device regulator expects: documented validation of special processes, controlled storage and handling, batch records that can reconstruct every shipment, and supplier controls that flow down to material mills.

What Customers Receive

• Dimensional reports with full drawing coverage on every batch.
• Material certificates traceable to heat numbers.
• Batch records linking parts, machines, programs, and inspection data.
• Cleanliness-conscious cleaning and packaging for components entering regulated assembly.

Medical Work at KGL

Medical devices are one of KGL's four focus sectors, covering orthopedic external fixation components, endoscope parts, and surgical instrument hardware. Practices and material notes are collected in our medical machining article series and on the ISO 13485 certification page.