Installation Qualification
Confirms that what makes the part is itself under control: machine and fixture identification, ancillary equipment list, gauge calibration validity, environmental conditions, and preventive maintenance plan.
Quality & Validation Capability
Machining capacity is common. What separates suppliers is whether they can pass your validation process. JIN-TI has completed FMEA, control plans, and OQ/PQ process validation — and passed an on-site supplier audit within an international medical device supply chain.
ISO 9001:2015 Certification
- Certificate Number
- 138450/A/0001/UK/En
- Issuing Body
- URS – United Registrar of Systems
UKAS accredited (0043) · IAF MLA member - Valid Until
- 2027-10-02
- Certified Scope
- Manufacture of Metal Scissors Products for used in Medical Device
The entire facility operates under the same quality management system procedures. The certified scope is as stated above; other product lines are managed under the same procedures and can be brought into the certified scope at customer request.
View Certificate (PDF)ISO9001:2015
URS · UKAS · IAF
We Have Completed the Full Validation Cycle
The biggest cost of onboarding a new supplier is not unit price — it is validation. JIN-TI has executed every stage below in practice.
Process Planning
PFMEA, control plan, process management plan (PMP), and inspection plan — every control characteristic traced back to the customer specification.
First Article Inspection (FAI)
Every dimension on the drawing measured and reported, accompanied by material certificates and gauge calibration validity.
OQ / PQ Process Validation
OQ proves the process holds at worst-case parameter limits; PQ proves long-term stability under production conditions. Protocol, execution records, and report — with acceptance criteria agreed in writing beforehand.
Supplier Audit
Passed an on-site supplier audit within a European medical device brand supply chain, covering quality system, lot control, process control, equipment calibration, nonconforming product control, and corrective/preventive action.
3Q Validation: IQ / OQ / PQ, Actually Completed
Having done it and being able to produce the documentation are two different things. Below are the three stages JIN-TI has executed — and reported on — in a cross-border medical device project.
Operational Qualification
Parameters are determined by experiment, not by operator instinct. A process window study runs the grid — laser power and welding speed, milling conditions, wire-EDM conditions — judging output at each setting to establish the acceptable upper and lower limits, and proving the process still yields conforming parts at worst-case settings.
Performance Qualification
Production runs under real manufacturing conditions with every piece measured, and process capability (Cpk) calculated. Acceptance criteria — including the Cpk threshold and sampling plan — are agreed with the customer in writing before the run, so results are never open to interpretation afterwards.
What a Validation Package Actually Contains
A supplier who has not been through it cannot produce this list. Each document exists to answer one specific question an auditor will ask.
- Validation Plan
- Equipment & Ancillary List (with calibration validity)
- Process Window Study
- Machine & Tooling Maintenance Plan
- Set-up Sheet
- Drawing Annotation
- First Article Inspection Report (FAI)
- Process Capability Analysis (Cpk)
- Validation Summary Report
End-to-End Batch Traceability (In-House ERP)
Every production stage is linked by its own serial number. Any part can be traced back to its raw-material lot, the processes it passed through, and every inspection result.
- 01 Incoming Inspection
- 02 Mill Certificate
- 03 Work Order
- 04 In-Process Inspection
- 05 Outsourced Incoming
- 06 Acceptance & Warehousing
When a customer needs quality evidence or a root-cause investigation, the full production history is available on demand — and during audits we can demonstrate live, tracing a shipment record back to its raw-material lot.
Materials & Measurement
Material Traceability
Tool steel is 100% imported from Europe, with a mill certificate for every batch. Because quality can differ between mills and regions even under the same grade designation, we control material by traceability rather than by grade number alone.
Measurement & Inspection
ARCS automated vision measuring systems, KEYENCE image dimension measurement, and Mitutoyo digital height gauges. Critical dimensions are inspected 100% or by sampling plan, data is stored digitally, and measurement reports can accompany each shipment. Tolerance capability to ±0.01 mm.
Evaluating a New Supplier?
We know the validation process — no need to teach it from scratch. Request our full supplier qualification package or arrange an on-site audit.
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