Quality Certifications
Our comprehensive portfolio of international certifications demonstrates our unwavering commitment to quality, safety, and regulatory compliance across global markets.
Our Certification Portfolio
Each certification represents our dedication to maintaining the highest standards of quality, safety, and environmental responsibility in silicone manufacturing.
ISO 13485:2016
Medical Device Quality Management
Certificate Purpose
Demonstrates our commitment to quality management systems specifically designed for medical device manufacturing, ensuring consistent product safety and efficacy.
Detailed Description
This certification validates our comprehensive quality management system for design, development, production, and servicing of medical devices. It ensures regulatory compliance across global markets including FDA, CE marking, and other international medical device regulations.
FDA 21CFR
Food Grade LSR Materials
Certificate Purpose
Validates that our liquid silicone rubber materials meet FDA requirements for direct food contact applications, ensuring consumer safety and regulatory compliance.
Detailed Description
Comprehensive testing and validation of our LSR materials according to FDA 21CFR 177.2600 standards. Includes migration testing, extractable analysis, and biocompatibility assessment for food-contact silicone products including kitchenware, baby products, and food processing equipment.
ISO/TS 16949:2016
Automotive Quality Management
Certificate Purpose
Ensures our manufacturing processes meet the stringent quality requirements of the automotive industry, enabling supply to major automotive OEMs worldwide.
Detailed Description
Comprehensive automotive quality management system certification covering design, development, production, and installation of automotive-related products. Includes advanced product quality planning (APQP), production part approval process (PPAP), and statistical process control (SPC) methodologies.
BSCI
Social Compliance Initiative
Certificate Purpose
Demonstrates our commitment to ethical business practices, worker rights, and social responsibility throughout our manufacturing operations and supply chain.
Detailed Description
Comprehensive social compliance audit covering worker rights, workplace safety, environmental protection, and ethical business practices. Ensures fair labor conditions, proper working hours, safe working environment, and compliance with local labor laws and international standards.
ISO 9001:2015
Quality Management System
LFGB
German Food & Feed Code
Disney FAMA
Facility & Merchandise Authorization
Global Compliance Standards
Our certifications ensure seamless market access and regulatory compliance across major international markets.
Medical Device
FDA, CE Mark, ISO 13485
Food Contact
FDA 21CFR, LFGB, GB Standards
Automotive
ISO/TS 16949, PPAP, APQP
Social Responsibility
BSCI, Disney FAMA, CPSIA
Partner with a Certified Leader
Our comprehensive certification portfolio ensures your products meet the highest international standards. Contact us to learn how our certified processes can support your quality requirements.