https://www.avient.com/sites/default/files/2023-10/ISO 13485-2016 cert_expire 28Feb2025_Avient%5B28%5D.pdf
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Certificate
Avient Colorants Singapore Pte Ltd
8 Third Chin Bee Road
Jurong Industrial Estate
618684 Singapore
Singapore
Scope
Administration, Site management, Manufacture,
Laboratory, Procurement, Maintenance,
infrastructure, Warehouse and Transport
Normative base
EN ISO 13485:2016 Medical devices – Quality Management System
Reg. no. 45483 Validity 01. 03. 2022 – 28. 02. 2025
Issue 01. 03. 2022
A.Grisard, President SQS F.
https://www.avient.com/sites/default/files/2024-12/ISO 22000_EN_Jurong.pdf
View PDF
The SQS herewith attests that the organisation named below has a management system that meets the requirements of
the normative base mentioned.
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Certificate
Avient Colorants Singapore Pte Ltd
8 Third Chin Bee Road
Jurong Industrial Estate
618684 Singapore
Singapore
Scope
Category I
Production of customer specific Masterbatches for
Food packaging materials on the dedicated extrusion
lines
Normative base
ISO 22000:2018 Food Safety Management Systems - Requirements
for any organization in the food chain
Reg. no. 46390
Page 1 of 1
Validity 25. 02. 2024 – 24. 02. 2027
Issue 25. 02. 2024
A.Grisard, President SQS F.
https://www.avient.com/news/polyone-expands-healthcare-portfolio-biomerics’-specialty-medical-solutions
To access PolyOne’s news library online, please go to www.avient.com/news.
Avient To Hold First Quarter 2025 Conference Call...
Avient Announces Quarterly Dividend...
https://www.avient.com/sites/default/files/2021-05/unterzertifikat-th.-bergmann.engl-.pdf
Robert Schmitt
Certification Body
This certificate is valid from: 20.05.2021 to: 19.05.2024
Certificate No.: 000461.1.E/21.R
This is a sub-certificate of the PolyOne Deutschland GmbH, Certificate No.: 000461.E/21.R.
Certificate
The SKZ-Cert GmbH Zertifizierungen certifies to the company
PolyOne Th.
Bergmann GmbH
Adolf-Dambach-Str. 2-4
76571 Gaggenau
the introduction and application of a management system according to
ISO 50001:2018
Scope:
DEVELOPMENT AND PRODUCTION OF TECHNICAL POLYMERS
The proof has been furnished by an audit.
https://www.avient.com/sites/default/files/2024-12/ISO 22000-2024. Avient Sta. Clara 308865_en_46389 %2811%29.pdf
View PDF
The SQS herewith attests that the organisation named below has a management system that meets the requirements of
the normative base mentioned.
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Certificate
Avient Colorants MX S.A. de C.V.
Normative base
ISO 22000:2018 Food Safety Management Systems - Requirements
for any organization in the food chain
Reg. no. 46389
Page 1 of 1
Validity 25. 02. 2024 – 24. 02. 2027
Issue 20. 12. 2023
A.Grisard, President SQS F.
https://www.avient.com/industries/healthcare/drug-delivery-systems/auto-injectors-and-drug-delivery-pens
ISO 13485 certified manufacturing sites
ISO 10993 and USP Class VI compliant solutions
Global manufacturing and product stewardship to help mitigate risk
https://www.avient.com/industries/healthcare/remote-monitoring-wearables/home-care-monitors
They can be overmolded onto a variety of substrates, are compliant with ISO 10993 & USP Class VI, and can be customized based on application need
Color and special effect masterbatches pre-tested to ISO, US Pharmacopeia, European Pharmacopeia, and ICH Q3D protocols for increased visual appeal and patient adherence to regular monitoring
Avient’s portfolio of healthcare colorants includes standard and customized color solutions for a variety of polymers, from polyolefins, PC, PEBA, ABS, and styrenics to high temperature polysulfone resins.
https://www.avient.com/industries/healthcare/drug-delivery-systems/prefilled-syringes
Colors standardized to RAL and Pantone color systems to align with ISO 6009 standard
Solutions compliant with USP Class VI and ISO-10993 regulations
Learn more about how Avient's medical-grade polymers, colorants and additives can enhance effectiveness and safety.
https://www.avient.com/sites/default/files/2022-08/ISO9001-2015 EN -EM.pdf
China
TEL: +86 21 32799000
Zhu Hai Ming
Management Representative
Lack of fulfilment of conditions as set out in the Certification Agreement may render this Certificate invalid.
ACCREDITED UNIT: DNV Business Assurance B.V., 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.
ACCREDITED UNIT: DNV Business Assurance B.V., Zwolseweg 1, 2994 LB, Barendrecht, Netherlands - TEL: +31(0)102922689. www.dnv.com/assurance
Page 2 of 2
Appendix to Certificate
Polyone - Suzhou, China
Locations included in the certification are as follows:
Site Name Site Address Site Scope
PolyOne Management
(Shanghai) Co., Ltd.
https://www.avient.com/sites/default/files/resources/NEU%2520ISO%25209001-2015%2520Exp%25201-22%2520%25281%2529.pdf
Validity of this certificate may be confirmed at www.abs-qe.com/cert_validation.
ISO 9001:2015
The Quality Management System is applicable to:
Certificate No: 47804
Certification Date: 07 January 2013
Effective Date: 17 December 2018
Expiration Date: 06 January 2022
Issue Date: 17 December 2018 Alex Weisselberg, President
This certificate may be found on the ABS QE Website (www.abs-qe.com).
For certificates issued in the People's Republic of China information may also be
verified on the CNCA website (www.cnca.gov.cn).