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Certificates of Silicone Protucts Manufacturing - Lanxin

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Founded in 1997, Lanxin is a trusted manufacturer specializing in custom processing of silicone and plastic products.Over the decades, we have worked with numerous domestic and foreign brands and provided thousands of customized solutions for a wide range of industries.

We have obtained the following internationally recognized qualification certifications. These certifications fully reflect Lanxin’s consistent adherence to the concept of standardized operation, systematic management and green and environmentally friendly production. Our company has established a complete management system with clear standards, standardized processes, traceable operating mechanisms, and continuous improvement. We are dedicated to delivering stable, reliable, and high-quality products and services, with a constant focus on meeting and exceeding customer expectations.

ISO 9001 – Quality Management System
ISO 14001 – Environmental Management System
ISO 13485 – Medical Device Quality Management System
IATF 16949 – Automotive Quality Management

What is ISO-9001 and ISO-14001 certification?

ISO-9001
ISO 9001 is an international quality management system certification standard issued by the international Organization for Standardization, applicable to organizations of all sizes, regardless of type, industry, or product category.
ISO 9001

ISO 9001 certification reflects the ability to achieve stable and high-quality delivery through standardized management, process optimization, efficiency improvement. Meanwhile, it is an essential qualification for entering the automotive, medical, food and other industries.

ISO-14001

ISO 14001 is a standard developed by the International Organization for Standardization, primarily aimed at helping companies establish a systematic environmental management framework to achieve environmental protection, pollution prevention, and sustainable development goals.

ISO 14001

We comply with environmental laws and regulations and have a complete set of practical actions, records and assessment systems to manage envoronmental impacts in production and operations, reduce pollution risks and comply with future sustainable development.

ISO-13485
ISO 13485:2016

What is ISO-13485 certification?

ISO 13485 is a quality management system standard designed for the medical device industry, ensuring that companies comply with regulatory requirements and customer needs in design, production, installation, and service.

“Passport” to the medical device market

ISO 13485 is a “passport” to enter the medical device market. It is a globally recognized basic standard for “quality assurance rules” specifically formulated for the medical device industry.

Standardized Management and Risk Control

Promote enterprises to establish standardized and efficient management processes, reduce risks, professional quality control capabilities, and emphasize risk management, traceability, design verification, product traceability and recall control.

IATF-16949
IATF 16949

What is IATF-16949 certification?

IATF 16949 is a global automotive industry quality management system standard developed by the International Automotive Task Force. It combines the requirements of ISO 9001 and makes more stringent extensions for the automotive industry.

Entry threshold for the automotive industry

The “essential key” to open the door to the automotive supply chain, specifically for automotive manufacturing and parts
The quality management system standards formulated by the supply chain are more stringent and industry-specific than ISO 9001.

High-quality products and Risk Management

Standardized process management and preventive control reduce waste and defects and improve overall operational efficiency, Comprehensive control in all aspects af design, production, inspection and delivery, more standardized supply chain management and problem tracing capabilities. Improve product consistency and zero defect level.

For more information about our qualification certificate, please contact us at services@cn-lanxin.com,we can send relevant documents for your review.

FDA, LFGB, RoHS and REACH Certifications

Lanxin has established a comprehensive supplier management system to ensure that raw materials are sourced from trusted suppliers, with strict quality control at every stage. All materials comply with international certification standards such as FDA, LFGB, RoHS,and REACH. This not only guarantees high quality products for customers but also helps mitigate legal and trade risks.

FDA LOGO

FDA certification is a prerequisite for entering the US market, ensuring that medical products and food that come into contact with the human body meet international safety standards. It is a globally recognized quality standard that makes it easier for products to be recognized by international customers and large companies.

LFGB LOGO

LFGB certification is a necessary condition for the legal sale of food contact products in Europe. It requires products to pass strict testing to ensure food safety. It can not only meet international safety standards and enhance product attractiveness, but also enable companies to ensure that their products comply with regulations and reduce legal and environmental risks.

ROHS LOGO

RoHS certification is the legal threshold for entering the EU market. It can ensure product compliance, help companies produce safer and more environmentally friendly products, demonstrate environmental responsibility, and avoid recycling and replacement costs.

REACH LOGO

REACH certification is the key to entering the EU market. It ensures product safety, maintains brand reputation, and encourages suppliers to optimize formulas and establish a green supply chain. At the same time, as a basic requirement for European and American customers, it helps buyers connect to the global market and attract high-quality customers.

What We Do ?

Lanxin provides mold processing, injection molding, LSR, hardware and die-cutting customization services. With our experienced team and advanced equipment,
we can handle various processes efficiently.

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Frequently Asked Questions

Read the Frequently Asked Questions for more information.
There’s no answer here for you? Please contact us and we will respond within 24 hours.

Usually silicone/rubber/plastic/metal, other materials such as stainless steel, aluminum, copper, and brass are also used according to product design requirements.
Rubber:NR, SBR, BR, IR, NBR and other rubbers.
Silicone:Antibacterial, biocompatible medical silicone.
Plastic:ABS, PS, PP, PVC, PC and other plastics.

We use clean and sustainable silicone materials that are certified by FDA and LFGB. If required, we will provide a raw silicone material test report.

Silicone is hypoallergenic, biocompatible (no adverse effects on the human), and chemical stability (highly inert). Therefore, silicone products are safe for human beings.

Of course, before customizing silicone, we will ensure that the materials provided are safe and meet specific regulatory and quality standards. In addition, the materials we provide have passed many authoritative certifications in Europe and the United States, such as FDA, ROHS, DMF, LFGB, etc.

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