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Quality Management and Compliance

Jan. 13, 2026

Certified Quality Management System for Underpad & Incontinence Care Manufacturing

As a professional underpad manufacturer and incontinence care manufacturer, Beijing Beishute has established a comprehensive and internationally recognized Quality Management System (QMS) to ensure consistent product safety, performance, and regulatory compliance.
Our quality system is built in strict accordance with ISO 9001, EN ISO 13485, FDA 21 CFR Part 820, and Medical Device GMP, covering the entire manufacturing process—from raw material sourcing and production to inspection, testing, packaging, and final delivery.

Regulatory Compliance for Global Incontinence Care Markets

Serving international medical and hygiene brands, we strictly comply with major regulatory requirements, including:
  • EU MDR (EU) 2017/745

  • U.S. FDA 21 CFR Part 820

  • China Medical Device Quality Management Regulations

This ensures our disposable underpads, incontinence pads, and related care products meet the compliance expectations of Europe, North America, and other global markets.

Advanced Testing Capabilities Backed by CNAS Accreditation

To guarantee stable product quality, our CNAS-accredited laboratory (2023) supports every production stage of our underpad and incontinence care products.
Testing capabilities include:
  • Physical and chemical performance testing

  • Microbiological testing

  • Sterility testing

  • USP (United States Pharmacopeia) microbiological testing

This allows us, as a reliable incontinence care manufacturer, to ensure safety, absorbency performance, and hygiene standards before shipment.

Comprehensive Management Systems Supporting Sustainable Manufacturing

Beyond quality control, Beijing Beishute continuously strengthens its management systems to support responsible and sustainable operations:
  • ISO 14000 – Environmental Management System

  • OHSAS 18001 – Occupational Health & Safety Management System

  • GB/T 29490-2013 – Intellectual Property Management System

  • ISO 50001:2018 – Energy Management System

These systems reinforce our position as a trusted long-term underpad manufacturer for global partners.

International Certifications You Can Rely On

  • EN ISO 13485:2016

  • ISO 9001:2015

With decades of manufacturing experience and a robust quality infrastructure, Beijing Beishute delivers OEM & ODM solutions as a professional underpad manufacturer and incontinence care manufacturer, supporting healthcare, elder care, and home-care markets worldwide.