Quality Control & Assurance System
ISO 9001:2015 & ISO 13485:2016 Certified Manufacturing with Comprehensive Testing
Raw Material Inspection
Production Inspection
Performance Test
Final Inspection
Our core quality engineering team has 20+ years of industry experience, with team members holding National Quality Engineer certifications.
Quality Certifications & Standards
ISO 9001:2015
Quality Management System
ISO 13485:2016
Medical Devices Quality
FDA 21 CFR 820
Quality System Regulation
CE Marking
European Compliance
Raw Material Inspection
Strict incoming material inspection system ensures only qualified materials enter production. All raw materials must pass physical and chemical testing before use.
- Supplier qualification - Pre-qualification audits and ongoing performance evaluation
- Incoming testing - Physical and chemical analysis for each batch
- CoA verification - Certificate of Analysis confirmation against specifications
- Storage monitoring - Temperature and humidity controlled warehouses
- Rejection system - Non-conforming materials returned or quarantined
Production Process Quality Inspection
Continuous monitoring throughout manufacturing ensures consistent product quality. Our quality team implements statistical process control at every critical control point.
- In-process checks - Regular sampling and inspection during production
- Equipment calibration - Regular verification of production equipment accuracy
- Operator certification - All operators trained and certified for their roles
- Batch tracing - Complete traceability from raw materials to finished products
- SPC monitoring - Statistical Process Control for key parameters
AQL Inspection Standards
We apply internationally recognized AQL (Acceptable Quality Level) standards for all inspections:
- AQL 1.5 - Critical defects (functional failures, safety issues, major visual defects)
- AQL 2.5 - Major defects (significant quality issues affecting usability)
- AQL 4.0 - Minor defects (cosmetic issues with minimal impact)
Reference Standards: ISO 2859-1 (Sampling procedures), ISO 3951 (Skip-lot sampling), ANSI/ASQ Z1.4
Laboratory Testing Capabilities
Physical Testing
- Absorbency rate & capacity
- Tensile strength
- Permeability (Loudry test)
- Thickness measurement
- Weight consistency
Chemical Analysis
- pH level testing
- Moisture content
- Material composition
- Whiteness evaluation
- Residue testing
Safety Testing
- Skin irritation test
- Allergen screening
- Microbial testing
- Fluorescence detection
- Hygiene standards compliance
Quality Documentation & Reports
For every OEM/ODM order, we provide comprehensive quality documentation:
- Inspection Report - AQL sampling results with detailed defect classification
- Test Certificates - Physical and chemical test results for each batch
- Material Certificates - CoA for all raw materials used in production
- Batch Records - Complete production history and traceability documents
- Certificate of Compliance - Confirmation of specification conformance
Frequently Asked Questions
What quality certifications does your factory have?
We hold ISO 9001:2015 (Quality Management System) and ISO 13485:2016 (Medical Devices Quality Management) certifications. Our facilities also comply with FDA 21 CFR Part 820 and CE requirements.
What is your AQL standard?
We apply AQL 1.5 for critical defects, AQL 2.5 for major defects, and AQL 4.0 for minor defects. Every batch undergoes comprehensive sampling inspection per ISO 2859-1 standards before shipment.
How do you ensure raw material quality?
We implement strict incoming material inspection with certificate of analysis verification. All materials must pass physical and chemical testing before entering production. Suppliers are pre-qualified and regularly audited.
What testing equipment do you have?
Our laboratory is equipped with: absorbency testers, tensile strength testers, pH meters, moisture analyzers, thickness gauges, and skin irritation test facilities. All equipment is regularly calibrated to international standards.
Do you provide quality reports for orders?
Yes, we provide comprehensive quality documentation including inspection reports (AQL results), test certificates, material certificates, and complete batch tracing records for all OEM/ODM orders.
How long has your quality team been in the industry?
Our core quality engineering team has over 20 years of experience in the hygiene products industry. Multiple team members hold National Quality Engineer certifications and receive regular professional training.
Partner with an ISO Certified Manufacturer
Our ISO 9001:2015 & ISO 13485:2016 certified quality control system with 20+ years experienced team ensures every product meets the highest international standards. AQL 1.5/2.5 inspection standards applied to all orders.
Quality Documentation: Inspection reports, test certificates, batch records, and material certificates available for all OEM/ODM orders.