Quality
Quality Assurance | ISO 9001 Injection Molding Factory | JBRplas
JBRplas is ISO 9001 & 13485 certified. Our quality system covers mold manufacturing, injection molding, inspection, and documentation — from DFM to final shipment.
Quality Assurance at JBRplas
Quality at JBRplas is built into every stage of the manufacturing process — not inspected in at the end. Our ISO 9001:2015 & 13485:2016 certified quality management system defines the standards, procedures, and responsibilities that govern every project from initial RFQ to final delivery.
Certifications
| Certification | Standard | Scope |
|---|---|---|
| ISO 9001:2015 | Quality Management System | Mold design, manufacturing, injection molding, assembly |
| ISO 13485:2016 | Medical Devices Quality Management System | Mold design, manufacturing, injection molding, assembly for medical devices |
| RoHS Compliance | EU Directive 2011/65/EU | Material compliance, resin selection |
| REACH SVHC | EU Regulation 1907/2006 | Chemical substance declarations |
Quality System Overview
Design Phase
- DFM Review — documented Design for Manufacturability analysis with written report for every project
- Moldflow simulation — fill, warp, and cooling analysis before tooling begins
- Design review — formal engineering sign-off before mold machining starts
- Customer approval — 2D and 3D mold design submitted for customer review before machining
Mold Manufacturing Phase
- In-process dimension checks — CMM verification at critical machining stages
- Steel hardness verification — Rockwell hardness tested and recorded per mold component
- Assembly inspection — mold assembled and verified against design dimensions before trial
- Trial documentation — all T1 / T2 process parameters recorded and retained
First Article Inspection (FAI)
Every new mold program goes through a documented First Article Inspection before production approval:
- Full dimensional report (all drawing dimensions measured and recorded)
- Visual inspection against cosmetic standard (approved sample or written standard)
- Material certificate — resin grade and lot traceability
- Process parameter record — injection settings at approved sample production
- Customer sign-off on first article samples before production release
Production Quality Control
| Control Point | Method | Frequency |
|---|---|---|
| First-off inspection | Full dimensional + visual | Start of every production run |
| In-process visual | Operator 100% inspection | Continuous |
| SPC monitoring | Critical dimension measurement | Every 50–100 shots (automated) |
| Outgoing AQL | ANSI/ASQ Z1.4 Level II | Per lot |
| Material verification | Resin lot cross-check | Per production batch |
Measurement Equipment
| Instrument | Specification | Purpose |
|---|---|---|
| CMM (Zeiss / Hexagon) | ±0.002mm | 3D dimensional measurement |
| Optical comparator | ±0.005mm | Profile and contour measurement |
| Surface roughness tester | Ra 0.001μm resolution | Surface finish verification |
| Hardness tester (Rockwell) | ±0.5 HRC | Steel hardness verification |
| Colour spectrophotometer | ΔE < 0.5 | Colour match verification |
| Pull-force tester | 0–500N | Snap-fit and insert retention testing |
All measurement equipment is calibrated on a scheduled basis with calibration certificates traceable to national standards.
Documentation Packages
| Document Type | Standard Programs | Automotive | Medical |
|---|---|---|---|
| DFM Report | ✅ | ✅ | ✅ |
| First Article Inspection | ✅ | ✅ | ✅ |
| Certificate of Conformance | ✅ | ✅ | ✅ |
| Material Certificate | ✅ | ✅ | ✅ |
| PPAP Level 3 | — | ✅ | On request |
| Control Plan | — | ✅ | ✅ |
| PFMEA | — | ✅ | ✅ |
| SPC Data (Cpk) | — | ✅ | On request |
| Lot Traveller | — | — | ✅ |
Non-Conformance Management
When a non-conformance is identified — whether detected internally or reported by a customer — JBRplas follows a structured corrective action process:
- Containment — immediate sorting, quarantine, and shipment hold if applicable
- Root cause analysis — 8D or 5-Why methodology within 48 hours
- Corrective action — process or tooling correction, implemented and verified
- Preventive action — update to control plan, FMEA, or operator instruction
- Closure — written CAPA report provided to customer
Our customer-reported defect rate for established programs is below 0.3%.
Supplier Quality Management
The quality of our output depends on the quality of our inputs. JBRplas maintains an approved supplier list for:
- Steel and mold component suppliers (inspected per certificate)
- Resin suppliers (approved brands only; lot certificates required)
- Surface treatment suppliers (plating, painting, texturing)
- Bought-in standard components (springs, fasteners, connectors)
All approved suppliers are audited annually.