Quality
Quality Assurance | ISO-Certified Injection Molding Factory | JBRplas
JBRplas is ISO 9001 & 13485 certified. Our quality system covers mold manufacturing, molding, inspection and documentation, from DFM to 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 | Manufacture and sales of plastic shells and plastic molds |
| ISO 13485:2016 | Medical Devices Quality Management System | Production and sales of plastic molds and plastic parts 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 (SEREIN) | ±0.001mm | 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.
Clean room production and injection molding fundamentals are covered in dedicated guides: when injection molding needs a clean room, what injection molding is and what it costs, and medical molding compliance documentation.
Related
- Manufacturing capabilities: Factory & equipment overview
- About JBRplas: 30+ years of manufacturing
- Why choose us: What sets JBRplas apart
- Auditing us: Five-phase supplier audit checklist

