We finished the annual inspection of ISO 13485

Published:

2025-01-15

We finished the annual inspection of ISO13485, the certification is applicable to:

Production and sales of disposable non sterile non-woven products(surgical gowns, protective coveralls, lab coats, scrub suits, isolation gowns, medical masks, caps, shoe covers, boot covers, aprons, bed covers, bed sheets)(export only); sales of disposable non sterile plastic (clothes, bed covers, sleeves, shoe covers, boot covers)(export only).

ISO 13485 is the internationally recognized standard for quality management systems in the design and manufacture of medical devices. It outlines specific requirements that help organizations ensure their medical devices meet both customer and regulatory demands for safety and efficacy.

While ISO 9001 applies to a wide range of industries, ISO 13485 is specifically tailored to the regulatory and safety requirements of the medical device industry. It emphasizes meeting regulatory as well as customer requirements, risk management, and effective process validation more than ISO 9001.

We use the ISO 13485 system to select and manage the downstream suppliers, so as to ensure high efficiency, stable quality, and advantage cost. All goods will go through a formal QC process, our sales also do random inspections before shipment. Our sales volume increased 50% in 2024, mostly increasing from old customers, because they reflected that our quality is good, and their customers increased the volume ,too.