--- title: Stelray Plastic Products - ISO Certificate, FDA Registration, cGMP description: Stelray Plastic Products, Inc. - ISO 9001:2015 Certificate --- [Skip to content](https://info.stelray.com/iso-certificate#main-content) [ sales@stelray.com](mailto:sales@stelray.com) [ +1(800) 735-2331](tel:1(800)%20735-2331) [![](https://info.stelray.com/hs-fs/hubfs/Stelray_May2018%20Theme/Images/logo-Vector-Stelray.png?width=244&height=101&name=logo-Vector-Stelray.png)](https://www.stelray.com/) - [Home](https://www.stelray.com) - [About Us](https://www.stelray.com/who-are-we) Show submenu for About Us - [Who We Are](https://www.stelray.com/who-are-we) - [Sample Projects](https://www.stelray.com/plastic-injection-molding-sample-projects) - [Our Services](https://www.stelray.com/plastic-injection-molding-services) Show submenu for Our Services - [Injection Molding Services](https://www.stelray.com/plastic-injection-molding-services) - [Quality Control](https://www.stelray.com/quality-control-plastic-injection-molding) - [Post Mold Services](https://www.stelray.com/injection-molding-secondary-decorating-services) - [Mold Making Services](https://www.stelray.com/custom-injection-mold-making-services) - [Engineering and 3D Prototypes](https://www.stelray.com/plastic-part-design-engineering-services) - [Medical Injection Molding](https://www.stelray.com/medical-injection-molding) - [Ultrasonic Welding Service](https://www.stelray.com/ultrasonic-welding) - [Blogs](https://www.stelray.com/blog) - [Reference Tables](https://www.stelray.com/reference-tables) - [Careers](https://www.stelray.com/careers) - [Contact Us](https://www.stelray.com/contact) - [Home](https://www.stelray.com) - [About Us](https://www.stelray.com/who-are-we) Show submenu for About Us - [Who We Are](https://www.stelray.com/who-are-we) - [Sample Projects](https://www.stelray.com/plastic-injection-molding-sample-projects) - [Our Services](https://www.stelray.com/plastic-injection-molding-services) Show submenu for Our Services - [Injection Molding Services](https://www.stelray.com/plastic-injection-molding-services) - [Quality Control](https://www.stelray.com/quality-control-plastic-injection-molding) - [Post Mold Services](https://www.stelray.com/injection-molding-secondary-decorating-services) - [Mold Making Services](https://www.stelray.com/custom-injection-mold-making-services) - [Engineering and 3D Prototypes](https://www.stelray.com/plastic-part-design-engineering-services) - [Medical Injection Molding](https://www.stelray.com/medical-injection-molding) - [Ultrasonic Welding Service](https://www.stelray.com/ultrasonic-welding) - [Blogs](https://www.stelray.com/blog) - [Reference Tables](https://www.stelray.com/reference-tables) - [Careers](https://www.stelray.com/careers) - [Contact Us](https://www.stelray.com/contact) # Stelray Plastic Products, Inc. - ISO 9001:2015 Certificate, FDA Registration, cGMP ## Welcome to our Quality Standards page, where we take pride in upholding the highest standards to ensure the excellence and safety of our products. As a testament to our commitment, we are proudly certified with ISO 9001:2015, demonstrating our dedication to quality management systems and continuous improvement. Additionally, our FDA registration showcases our compliance with the rigorous regulations set by the Food and Drug Administration, emphasizing our commitment to product safety and efficacy. We also adhere to current Good Manufacturing Practices (cGMP), ensuring that our manufacturing processes consistently meet the highest quality standards. Explore this page to gain insights into our unwavering commitment to quality and the measures we take to deliver products of the utmost integrity. ![Amtivo ISO 9001 Certificate 2025](https://info.stelray.com/hs-fs/hubfs/Amtivo%20ISO%209001%20Certificate%202025.png?width=1545&height=2000&name=Amtivo%20ISO%209001%20Certificate%202025.png "Amtivo ISO 9001 Certificate 2025") ![GMP Certified Badge](https://info.stelray.com/hs-fs/hubfs/GMP%20web-1.png?width=168&height=178&name=GMP%20web-1.png "GMP Certified Badge") ![FDA Certification Badge](https://info.stelray.com/hs-fs/hubfs/FDA%20web-1.png?width=166&height=183&name=FDA%20web-1.png "FDA Certification Badge") Why Are These Quality Assurance Standards Important? Obtaining ISO 9001:2015 certification, cGMP (current Good Manufacturing Practices) certification, and FDA (Food and Drug Administration) registration is of paramount importance in the realm of plastic injection molding for several compelling reasons. These certifications and registrations signify a commitment to quality, safety, and regulatory compliance, essential elements in industries where precision, reliability, and adherence to strict standards are critical. The integration of ISO 9001:2015 standards, cGMP certification, and FDA registration in plastic injection molding is a comprehensive approach to quality assurance and regulatory compliance. This not only instills confidence in customers and end-users but also opens doors to new opportunities in industries where adherence to these standards is non-negotiable. Ultimately, these certifications and registrations serve as a testament to a commitment to excellence, safety, and reliability in the production of plastic components through injection molding. Why is an ISO 9001:2015 Certificate important? ISO 9001:2015, an international standard for quality management systems, sets the framework for a systematic approach to managing processes and ensuring continuous improvement. In the context of plastic injection molding, this certification signifies that the manufacturer adheres to stringent quality control measures throughout the production process. It fosters consistency, efficiency, and customer satisfaction, as the emphasis is placed on meeting customer requirements and delivering products that meet or exceed expectations. Why is an FDA Registration important? FDA registration is a legal requirement for companies involved in the production of medical devices, which often utilize plastic injection molding for manufacturing components. Registration with the FDA is crucial for ensuring that products meet regulatory standards for safety and efficacy. It involves thorough documentation and compliance with FDA regulations, providing a level of assurance to both manufacturers and end-users that the products are manufactured in accordance with established guidelines. Why is cGMP adherence important cGMP certification is particularly relevant in industries like healthcare and pharmaceuticals, where the end-products may include medical devices or components. These regulations, set by health authorities, outline the necessary controls for design, monitoring, and manufacturing, ensuring that the final product is safe, effective, and meets the specified quality standards. In plastic injection molding, adherence to cGMP principles guarantees that the manufacturing processes are well-controlled, preventing defects and ensuring the production of high-quality components. ### Stelray Plastic Products, Inc. Address: 50 Westfield Ave., Ansonia, CT 06401 Phone: [+ 1 (800) 735-2331](tel:0444486534) Email: [sales@stelray.com](mailto:sales@stelray.com) [Follow us on Facebook](https://www.facebook.com/StelrayPlasticProducts/) [Follow us on LinkedIn](https://www.linkedin.com/company/stelray-plastic-products/) ### Stelray Blogs - [A Great Past: The History of Plastic](https://www.stelray.com/blog/a-great-past-the-history-of-plastics) - [Resilience: The Story of Stelray](https://www.stelray.com/blog/the-story-of-stelray) - [Critical to Quality: Caring for Your Injection Mold](https://www.stelray.com/blog/critical-to-quality-caring-for-your-injection-mold) - [A Great Past: The History of Plastic](https://www.stelray.com/blog/a-great-past-the-history-of-plastics) - [Resilience: The Story of Stelray](https://www.stelray.com/blog/the-story-of-stelray) - [Critical to Quality: Caring for Your Injection Mold](https://www.stelray.com/blog/critical-to-quality-caring-for-your-injection-mold) ### Pages - [Contact Us](https://www.stelray.com/contact) - [Reference Tables](https://www.stelray.com/reference-tables) - [Quality Control](https://www.stelray.com/quality-control-plastic-injection-molding) - [Contact Us](https://www.stelray.com/contact) - [Reference Tables](https://www.stelray.com/reference-tables) - [Quality Control](https://www.stelray.com/quality-control-plastic-injection-molding) ![Stelray certified by the FDA for Current Good Manufacturing Practice (CGMP)](https://info.stelray.com/hs-fs/hubfs/Stelray%20Website%20Optimzation%20202401/quality-certifications/GMP-footer-118x100px.jpg?noresize&width=118&height=100&name=GMP-footer-118x100px.jpg) ![ISO-9001 (002)-1](https://info.stelray.com/hs-fs/hubfs/ISO-9001%20(002)-1.png?noresize&width=963&height=1187&name=ISO-9001%20(002)-1.png) ![Stelray certified by the FDA as a Registered Medical Device Manufacturer](https://info.stelray.com/hs-fs/hubfs/Stelray%20Website%20Optimzation%20202401/quality-certifications/FDA-footer-118x100px.jpg?noresize&width=118&height=100&name=FDA-footer-118x100px.jpg) - [Privacy Policy](https://info.stelray.com/privacy-policy) - [Cookie Policy](https://info.stelray.com/cookie-policy) - [Sitemap](https://www.stelray.com/site-map) Copyright © 2026 Stelray Plastic Products, Inc. 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