OEM Diaper & Hygiene Products Quality Control & ISO Certified Inspection System

Our Putian factory holds ISO 9001:2015 (Quality Management System), ISO 13485:2016 (Medical Devices Quality Management), FDA 21 CFR Part 820 (Quality System Regulation), and CE Marking for European market compliance. We also hold GMPC certification for cosmetic-grade wet wipes production. All certificates are verifiable through issuing body databases. We welcome third-party factory audits by SGS, Intertek, Bureau Veritas, or TUV — our quality team will coordinate scheduling and provide full access to production records, calibration logs, and QC data.

We apply a three-tier AQL system per ISO 2859-1: AQL 1.5 for critical defects (functional failures, safety hazards, contamination — automatic lot rejection), AQL 2.5 for major defects (poor elastic tension, uneven SAP distribution, tape adhesion failure, seal integrity issues), and AQL 4.0 for minor cosmetic defects. In-line QC sampling occurs every 30 minutes on all active production lines. Pre-shipment inspection with full AQL sampling is mandatory for every export order.

Raw material quality control follows a 5-point IQC process: (1) Supplier pre-qualification through factory audits and ongoing performance scorecards. (2) Certificate of Analysis verification against internal specifications for every incoming batch. (3) Physical and chemical testing in our ISO 17025-standard lab — SAP absorption rate, pulp fiber length, nonwoven tensile strength, wet wipes substrate integrity. (4) Microbiological screening for bacterial and fungal limits. (5) Climate-controlled FIFO warehouse storage with temperature and humidity monitoring. Non-conforming materials are quarantined immediately and returned to supplier.

Our in-house laboratory is equipped for comprehensive hygiene product testing: absorbency testers (ISO 11948-1 method), rewet under pressure testers (0.7 kPa and 1.0 kPa), tensile strength testers (MD and CD direction), pH meters (surface and extraction), moisture analyzers, thickness gauges, formaldehyde detection (UV-Vis spectrophotometry), microbial testing facilities (total plate count, specified pathogens), skin irritation test equipment (ISO 10993-10), fluorescence detection (UV lamp), and SAP retention capacity testers. All equipment is calibrated to ISO/IEC 17025 standards with digital calibration records.

Yes, every OEM/ODM order ships with a complete quality documentation package: AQL Inspection Report with detailed defect classification and accept/reject numbers, Test Certificates showing physical and chemical results per batch, Material Certificates (CoA) for all raw materials, Batch Production Records with full traceability from raw material lot to finished carton, and a Certificate of Compliance. All documents are provided digitally (PDF) before shipment and in hard copy with the container. Full traceability from raw material receipt to container loading is standard for every order.

Absolutely. We welcome third-party QC inspections by SGS, Bureau Veritas, Intertek, TUV, or any inspection agency you designate. Our quality team will coordinate scheduling, provide full access to the production floor, QC records, calibration certificates, and test data. We can arrange inspection at any stage: during production (DUPRO), final random inspection (FRI) before shipment, or container loading supervision (CLS). Most third-party inspections are completed within 1-2 business days with reports shared directly with your procurement team.