Avient has 78 facilities worldwide certified to the ISO9001 standard. For our sensitive applications, in addition to ISO9001, we have implemented ISO 13485 and Good Manufacturing Processes (GMP). 100% of our facilities producing those sensitive applications and warehouses are GMP audited within a three-year period. In 2021, we anticipate formalizing and standardizing our approach to Life Cycle Analysis (LCA) and fully prioritizing the product portfolio in all critical markets/materials. 78 ISO9001 Certified FACILITIES ZERO Major Non-Conformances at ISO Sites HOME | Contents | Message from the CEO | Who We Are | People | Products | Planet | Performance | Goals & Metrics | Indices Sustainability Report | 2019 60Sustainability Report | 2019 60 Supplier Evaluation We seek to collaborate with excellent organizations that espouse our values and principles to bring innovation, sustainable materials and efficient processes to Avient and our customers.

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.

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.

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.

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.

These include ISO pre-certified colorants; FDA-compliant materials from engineering thermoplastics and elastomers to vinyl, styrenics and olefins; RoHS and REACH compliant materials; and much more.