MEDICAL DEVICE PRODUCT DEVELOPMENT | ISO 13485 QUALITY SYSTEM | OEM / ODM
Inspection Capability

Measurement supports consistent quality

Approved specifications guide incoming, first article, in-process and outgoing inspection, with measurement and lot records maintained as required.

IQC

Incoming Inspection

Inspection Focus
Material, dimensions, appearance, supplier documents and lot confirmation.
Record / Output
IQC records, material certificates and disposition
FAI

First Article Inspection

Inspection Focus
Dimensions, tolerances, CTQs and process settings against approved drawings.
Record / Output
FAI report, measurement records and process release
IPQC

In-process Inspection

Inspection Focus
Critical dimensions, assembly conditions, appearance and process stability.
Record / Output
IPQC records, trend monitoring and improvement actions
OQC

Outgoing Inspection

Inspection Focus
Appearance, dimensions, function, packaging and labeling under the approved sampling plan.
Record / Output
OQC report, lot records and shipping documents
Measurement Equipment

Measurement equipment selected by part characteristics

PROCH coordinate measuring machine performing precision dimensional inspectionCMM

Coordinate Measuring Machine

Precision measurement for complex geometry, position, coaxiality, profiles and critical dimensions.

PROCH AOI vision measurement and cosmetic inspection systemAOI

AOI Vision Measurement & Cosmetic Inspection System

Non-contact optical imaging inspection for high-volume, continuous and automated evaluation of part dimensions, cosmetic flaws and defects.

PROCH TRIMOS height gauge and granite measurement platformPROCH Mitutoyo dial indicator and granite measurement platformHEIGHT

Height Gauge & Platform Measurement

Height, step, flatness and datum verification for first article and in-process inspection.

PROCH dedicated gauges and inspection fixtures for dimensional verificationGAUGE

Dedicated Gauges & Fixtures

Go/No-Go, plug, ring and dedicated inspection gauges planned around project CTQs.

PROCH automated optical measurement system for non-contact inspectionOPTICAL INSPECTION

Automated Optical Measurement System

Non-contact measurement for rapid inspection of part length, hole diameters, spacing, profiles and height differences.

01Drawing & CTQ Control

Convert critical dimensions and quality characteristics into executable inspection items.

02Gauge Calibration Control

Manage measurement equipment status and calibration records by defined intervals.

03Lot Traceability

Connect material, process, inspection and shipment information.

04Closed-loop Improvement

Use containment, analysis, corrective and preventive actions to reduce recurrence.

Quality Records

Quality Traceability

From materials, processes and inspection through shipment, lot and quality records establish a traceable product history so related process conditions, inspection results and handling records can be reviewed quickly when an exception occurs.

Material CertificateIncoming Lot
Process RecordProduction Conditions
Inspection DataFAI & IPQC
Shipping DocumentsOQC & Packaging
NonconformanceCAPA Records