Global ISO Certificate Library

Global ISO Certificate Library

Global ISO Certificate Library

Global ISO Certificate Library

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.

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.

ISO 13485 certified manufacturing sites ISO 10993 and USP Class VI compliant solutions

Mevopur™ Healthcare Colorants, Functional Additives, and Bio-based Formulations: Manufactured across a global network of ISO 13485 facilities, this broad portfolio is pre-tested to United States Pharmacopeia (USP) Class VI, ISO 10993, USP 661, European Pharmacopeia 3.1, and International Conference on Harmonization (ICH) Q3D protocols.

NEU™ Custom Capabilities and NEUSoft™ Thermoplastic Polyurethanes are developed for short-term in-vivo applications that offer good elasticity, radiopacity, excellent UV stability and protection against moisture and oxygen while meeting ISO 10993 & USP Class VI standards.