https://www.avient.com/company/sustainability/planet/environmental-stewardship
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
https://www.avient.com/sites/default/files/2024-03/QF-02 QMS Global Standard Response.PDF
Audits are at the discretion of Avient and may be limited in content/scope.
6
Management Responsibility
The following information describes minimum requirements in place at all ISO 9001 certified manufacturing
facilities identified at http://www.avient.com/company/sustainability/environmental/global-iso-certificate-library
Some additional certified management systems are described in the annex to this document.
page=19
7
Quality Management
3rd Party Certifications
All manufacturing facilities are certified to the ISO 9001 standard.
Some have additional certifications such as
ISO 13485, ISO 14000, ISO 22000 and other third-party certified standards such as Responsible Care® and
IATF.
https://www.avient.com/resources/safety-data-sheets?page=6053
DYNAFLEX(TM) G7930-9001-02 P
DYNAFLEX(TM) G7960-9001-02 P
https://www.avient.com/news/medtec-china-2024-avient-announces-healthcare-tpu-manufacturing-expansion
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.
https://www.avient.com/sites/default/files/2022-08/ISO9001-2015 EN -EM.pdf
Zwolseweg 1, 2994 LB, Barendrecht, Netherlands - TEL: +31(0)102922689. www.dnv.com/assurance
Certificate No:
2997-2006-AQ-RGC-RvA
Initial certification date:
08 June, 2006
Valid:
11 April, 2022 – 11 April, 2025
This is to certify that the management system of
Polyone - Suzhou, China
EM Sector, 77 Shenggang Street, Suzhou Industrial Park, Suzhou, Jiangsu, China,
215024
and the sites as mentioned in the appendix accompanying this certificate
has been found to conform to the Quality Management System standard:
GB/T 19001-2016/ISO 9001:2015
This certificate is valid for the following scope:
Design and Manufacture of Plastic Compounding Material
Certificate No: 2997-2006-AQ-RGC-RvA
Place and date: Shanghai, 27 April, 2022
Lack of fulfilment of conditions as set out in the Certification Agreement may render this Certificate invalid.
https://www.avient.com/sites/default/files/2024-12/ISO9001_English_Suzhou ColorMatrix.pdf
Ltd
Business Registration Number: 91320505799067336K
Registered I Operation Address: 13 Plant, No.855, Zhujiang Road, Suzhou New District, Jiangsu Province, China
by reason of its
Quality Management System
has been awarded this certificate for compliance with the standard
ISO 9001:2015
The Quality Management System Applies in the following area:
Production Activities of Plastic Colorant & Additive (UV Blockers, Anti-Oxidation, Anti-Aging)
Certified since: January 8, 2009 Valid from: January 16, 2024 Valid until: January 4, 2027
the expiry date of last certification cycle: January 4, 2024 the date of recertification audit: December 21, 2023 to December 22, 2023
After a surveillance cycle, the certificate is valid only when used together with an Acceptance Notice of Surveillance Audit issued by CQC.
https://www.avient.com/sites/default/files/2024-07/Colorants _ Additives for Appliances Brochure.pdf
SUSTAINABILITY
Avient’s color and additive manufacturing sites
comply with ISO standards such as ISO 9001:2015
QMS, ISO 14001:2015 Environmental Management
System and ISO 45001:2018*.
EC) 1907/2006 and amendments)
• UL94 file for MB (QMQS.E73454) and formulations
(QMQS.E103015)
• “Toys declaration” Directive 2009/48/EC
• Waste Electrical & Electronic Equipment (WEEE)
* Contact us for more detailed information about our ISO certifications.
https://www.avient.com/products/vivo-formulations-healthcare/neusoft-thermoplastic-polyurethanes
USP Class VI and ISO 10993-4/5 compliant
ASTM ISO Shore A/D
ASTM/ISO %
https://www.avient.com/news/avient-highlight-bio-based-polymer-solutions-pharmapack-2024
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
https://www.avient.com/products/polymer-colorants/healthcare-colorants/mevopur-healthcare-colorants-and-formulations
Standard colors for use in needle hubs (ISO 6009)
Global network of ISO 13485 certified manufacturing sites
ISO 6009 color range