Dual authentication, covering medical and industrial manufacturing
| System | ISO 13485:2016 Medical Device Quality Management System |
ISO 9001:2015 General Quality Management System |
|---|---|---|
| Scope of application | Medical devices and related services (molding, injection molding, assembly) | All industrial molds, injection molded parts, and automation equipment |
| Core focus | Regulatory compliance, risk management and control, product safety, traceability | Customer satisfaction, continuous improvement, process approach |
| Key additional requirements | Design and development control, sterile environment requirements, implant traceability | No additional medical requirements |
| Two-wing covered product | Microfluidic chips, surgical instrument handles, medical consumables, IVD components, etc. | Automotive parts, home appliance casings, electronic connectors, industrial plastic components, etc. |
Quality Policy - Top Management Commitment
“Two Wing Mold always aims for zero defects. Through full participation, process control, and continuous improvement, we provide moulds and injection-molded products that meet or even exceed customer expectations. We promise:
All quality-related documents (SOPs, drawings, inspection standards, process parameter tables) are controlled and managed in the ECN system (Engineering Change Notice), and only the latest versions are available for on-site use.
Each document has a unique number, version number, effective date, and review signature; obsolete documents are immediately recycled and destroyed. Document reviews are conducted once a year.
Each position (Injection Molding Technician, QC Inspector, Mold Fitter) requires passing a theoretical + practical assessment to obtain a work permit. Recertification is required annually.
New employee training includes the basics of the quality system, identification of non-conforming products, and use of measuring tools; key positions (such as SPC monitors) require additional passing of a statistical technology exam.
Perform IQ/OQ/PQ (Installation/Operational/Performance Qualification) for special processes such as injection molding, welding, and dispensing, and lock in key process parameters (injection pressure, holding time, mold temperature, etc.).
After the trial molding of each new product, a Cpk study (with critical dimension Cpk ≥ 1.33) shall be conducted, and it can only be transferred to mass production after being verified through three consecutive batches.
Upon discovery of non-conforming products, immediately isolate, label, and record them (NCR), and proceed with rework, scrap, or concession acceptance. After analyzing the root cause, initiate CAPA (Corrective and Preventive Action).
All NCRs are tracked in the ERP system, and monthly summaries and analyses of TOP issues are conducted; the CAPA closure rate is included in departmental performance evaluation.
Conduct a full-process internal audit at least once a year (covering all clauses), and issue non-conformities if any issues are found; the management review is chaired by the general manager, and reviews the achievement of quality objectives, resource requirements, and improvement opportunities.
Internal auditors are independent of the audited department; management review outputs include improvement projects, budget adjustments, etc.
From Order to Shipment - Quality Closed-loop Flowchart
Two Wing Mold is a premier one-stop manufacturer of plastic injection molds and related services, based in ShenZhen, China. With a core leadership team that brings over 20 years of extensive industry experience, we combine deep technical expertise with proven craftsmanship to deliver superior molding solutions.
