ISO 9001 · ISO 13485 · Audit Support

Quality System & Supplier Audit Support

Documented inspection, traceability and audit support for medical device development, procurement and supplier-quality teams.

PROCH coordinate measuring machine for precision measurement — PRECISION MEASUREMENT

PROCH vision measurement and visual inspection — VISION & VISUAL INSPECTION

PROCH height gauge and platform measurement — PROCESS INSPECTION

CPK ≥ 1.33Agreed critical-dimension target

1 µm CMMMeasurement resolution

C=0 AQL 0.4–1.0Applicable sampling levels are selected according to customer quality requirements.

IQC・FAI・IPQC・OQCProduction-stage records

Quality Management

Building Verifiable Quality Evidence Through the Quality System

PROCH manufacturing operations are supported by ISO 9001 and ISO 13485 quality management systems. Project controls are defined against approved drawings, specifications, critical-to-quality characteristics and agreed inspection plans.

DOCUMENT CONTROL

Document & Revision Control

Approved drawings, revisions, specifications and production documents are controlled throughout project transfer and production.

INSPECTION RECORDS

Inspection Records

FAI, incoming, in-process and outgoing inspection records can be maintained according to project requirements.

TRACEABILITY

Traceability & Change

Lot identification, inspection status, nonconformance handling and agreed engineering changes support ongoing monitoring.

Inspection Flow

Inspection aligned with production stages

IQCIncoming InspectionMaterial and purchased-component verification

FAIFirst ArticleConfirmation against approved drawings and specifications

IPQCIn-process InspectionMonitoring of critical dimensions and process conditions

OQCOutgoing InspectionFinal disposition, records and shipment release

Audit-ready Package

Audit-ready supplier qualification support under NDA

Evidence is prepared within the agreed disclosure scope to support initial supplier qualification and ongoing monitoring without duplicating production-process content.

SYSTEM REVIEW

Quality Agreement & System Review

Certificate copies, quality manual or procedure-list information, and agreed quality-agreement topics such as change notification, audit rights, record retention and nonconformance reporting can be prepared within the approved scope.

CALIBRATION

Calibration, Training & Audit Preparation

Relevant calibration status and training-record summaries can be organized in advance for agreed onsite or remote audit activities.

MONITORING

Monitoring & Performance Evidence

Agreed lot records, inspection reports, quality trends and supplier-performance information can support qualification review, re-evaluation and ongoing monitoring.