ISO 13485:2016 Certified Medical Device Machining
Certificate 50526YY00027R000 by NQCC for precision hardware parts processing, supporting medical device manufacturers from prototype through validated series production.
ISO 13485:2016 is the quality management standard for suppliers to the medical device industry. It adds risk management, lot traceability, and process validation on top of ISO 9001. KGL started the certification project in late 2024, closed the gaps through 2025, and passed the initial audit in May 2026.
Certificate Facts
| Standard | Certificate No. | Body | Scope | Valid |
|---|---|---|---|---|
| ISO 13485:2016 | 50526YY00027R000 | NQCC | Precision hardware parts processing (excluding items requiring medical device production license qualification) | 2026-05-15 to 2029-05-14 |
What the Standard Requires
The standard expects documented control of production under a risk management mindset aligned with ISO 14971, traceability by lot, validation of processes whose output cannot be fully verified by inspection, and corrective action that weighs patient-safety impact.
It also expects contamination and handling controls appropriate to the part, and supplier controls for any special process performed outside the factory.
How It Runs at KGL
Traceability by lot. Material certificates, operator, inspection report, and finishing batch are tied to one lot number for every medical job.
Handling controls. Medical parts are segregated when the drawing calls for it, cutting fluids are controlled against residue, and packing uses sealed bags with desiccant after final inspection.
Validated special processes. Surface treatment and heat-treatment steps performed by approved subcontractors carry validation records and supplier approval records.
The original certificate scan: ISO 13485:2016 certificate page. For surface routes on medical parts, see passivation and anodizing.
Cross entrances: inspection and QC | tolerance standards | AQL sampling | surface treatment.
Frequently Asked Questions
What is the ISO 13485:2016 certificate number?
50526YY00027R000, issued by NQCC (Neutral Quality Connection Certification Guangdong). It is valid from 2026-05-15 to 2029-05-14, with surveillance audits at least once per calendar year.
Does the scope allow you to manufacture finished medical devices?
No. The scope covers precision hardware parts processing and excludes items that require a medical device production license. KGL supplies machined components; the customer stays responsible for final-device regulatory approval.
Which medical parts do you machine?
Surgical instruments, orthopedic brackets, endoscope housings, and implant-related fixtures, typically in titanium, stainless steel, and PEEK.
How do you trace a medical lot?
Every medical job carries a lot number tied to the raw-material certificate, machine operator, CMM report, and surface-treatment batch. A customer question about a specific batch gets an answer in minutes, not days.
Do you assemble or sterilize devices?
No. Medical parts are cleaned, inspected, and packed in sealed bags with desiccant after final inspection. Final assembly and sterilization stay with the device manufacturer.
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