ISO Name ISO 9001 ISO 9001

Homepage // News Center // Avient Site in Glendale, Arizona Earns ISO 13485 Certification The Avient facility in Glendale, AZ recently received ISO 13485 certification demonstrating the company’s commitment to providing healthcare solutions. ISO 13485 is an internationally recognized standard for quality management systems in the medical device industry.

Homepage // News Center // PolyOne Specialty Coatings and Inks Kennesaw, GA Plant Achieves ISO 9001-2008 Certification CLEVELAND – PolyOne today announced that its Specialty Coating and Inks plant in Kennesaw, GA recently achieved ISO 9001-2008 certification. Kennesaw is the third plant in our Specialty Coatings business to achieve ISO 9001-2008 certification, joining our Mountain Top, PA and Long Beach, CA facilities,” Bindner said.

Homepage // News Center // Avient Site in Taiwan Earns ISO 13485 Accreditation; Fourth Source for MEVOPUR™ ‘Medical-Grade’ Materials Caption: Avient Corporation today announced the ISO 13485:2016 certification of its production site in Taoyuan, Taiwan (near Taipei). ISO 13485 certification is the culmination of two years’ work to create a completely segregated, dedicated healthcare operation similar to other MEVOPUR plants.

Avient has 102 global manufacturing facilities. 96% of these sites are certified through independent third parties to management system standards including ISO:14001, ISO:50001, ISO:22000, ISO:45001, ISO:9001, and Responsible Care®. This methodology was developed in accordance with ISO 14067:2018 for product carbon footprint and is aligned with ISO 14040/140440 for life cycle analysis. Major Non-Conformances at ISO Sites

DIN EN ISO 105-B06 DIN EN ISO 105-C04 DIN EN ISO 105-P02 DIN EN ISO 105-X12

ISO 14001 certifications follow intensive environmental audits of organizations, conducted by third-party ISO representatives. At present, multiple Avient facilities hold ISO 14001 Certification. Global ISO Certificate Library

Additionally, Avient’s ISO 13485 manufacturing site in Singapore for its Mevopur™ formulations recently achieved ISO/IEC 17025 accreditation for Biological Evaluation of Medical Devices–Part 5: Tests for In-Vitro Cytotoxicity.  Mevopur™ Healthcare Colorants and Functional Additives: formulations pre-tested to support compliance with regulatory requirements, such as USP Class VI, ISO 10993, EP3.1, USP661.1, and ICH Q3D and manufactured across a global network of ISO 13485-certified facilities or under GMP certifications. PCF values are available for these products and are based upon a TUV-certified ISO-14067: 2018 process.

USP Class VI and ISO 10993-4/5 compliant ASTM ISO Shore A/D ASTM/ISO %

Like other Mevopur products, they are formulated with raw materials tested to ISO 10993-1 and USP , European Pharmacopeia 3.1.3 and 3.1.5, USP and ICH Q3D.   Certified for USP Class VI and ISO 10993, the new Versaflex HC BIO BT218 grade is commercially available globally. Versaflex™ HC Thermoplastic Elastomers series HC3810: translucent TPE formulations offering excellent colorability for injection molded parts and over-molding, developed to comply with ISO 10993-4 and -5, REACH SVHC, and RoHS