Global ISO Certificate Library

Avient currently has twenty-three facilities globally certified to the Corporation’s GMP program and two facilities certified to "ISO 13485, Medical Device - Quality Management Systems - Requirements for Regulatory Purposes." Global ISO Certificate Library

HAZEL ISO FIX DOOR V3 MAUVE DOOR, ISO FIX COVER V3

This certification, in conjunction with the facility’s existing ISO 22000-certified Food Safety Management System and ISO 13485-certified Quality Management System for medical devices, also positions the Chin Bee site to meet stringent hygiene and regulatory requirements for products for mothers and children, food-contact packaging, and the medical and pharmaceutical industries.

Like other Mevopur products, the bio-based polymer solutions are formulated with raw materials pre-tested to ISO, USP, EP, and ICH Q3D protocols, supporting their compliance with safety and regulatory requirements for use in healthcare.   In Europe, Mevopur concentrates and ready-to-use formulations are manufactured in the ISO 13485-2016 certified site of Malmö, Sweden.

Because Transcend is fully bio-compatible per ISO 10993 standards, we’re helping customers speed up development and market introduction. They are tested to ISO 10993 standards and can be customized with the addition of functional additives to enhance product performance.

Avient's PCF Calculator adheres to the globally recognized ISO 14067:2018 standard for calculating Product Carbon Footprint and has obtained additional third-party certification through TÜV Rheinland for ISO 14067 compliance.  

They are also certified to meet biocompatibility requirements for ISO 10993 and USP Class VI standards. Avient's Suzhou facility operates under ISO 13485 quality management system certification, complying with the leading standards in medical device manufacturing.

This includes information when you sign up to learn more about becoming a supplier; or when you request documentation regarding SDS, ISO, REACH, ROHS, or UL documentation. EMEA Pommerloch / Luxembourg Salce Office Regional Headquaters PolyOne S.à r.l., Avient Luxembourg S.à r.l., 19 Route de Bastogne Pommerloch, Luxembourg, L-9638 Global ISO Certificate Library

Normative basis EN ISO 13485:2016 Medical devices – Quality Management System Reg. no. EN ISO 13485:2016 H61173 01.03. 2025 29.02. 2028 Locations Scope Norm / Revision Reg. no. EN ISO 13485:2016 H61173 01.03. 2025 29.02. 2028 Avient Colorants USA LLC 17 Foss Rd.