https://www.avient.com/sites/default/files/2023-01/45324-Certificate-13JAN2023.pdf
ABS Quality Evaluations
This is to certify that the Quality Management System of:
Avient Corporation
Avient Corporation - McHenry, IL
831 Ridgeview Drive
McHenry, IL 60050
U.S.A.
ISO 13485:2016
The Quality Management System is applicable to:
Certificate No: 45324
Certification Date: 24 February 2014
Effective Date: 13 January 2023
Expiration Date: 23 January 2026
Revision Date: 13 January 2023 Dominic Townsend, President
DESIGN, MANUFACTURE AND DISTRIBUTION OF THERMOPLASTIC ELASTOMER RESINS & PELLETS FOR THE
MEDICAL DEVICE INDUSTRY
This certificate may be found on the ABS QE Website (www.abs-qe.com).
WITH ADDITIONAL FACILITIES LISTED ON ATTACHED ANNEX)
Certificate Of Conformance
has been assessed by ABS Quality Evaluations, Inc. and found to be in conformance with the requirements set forth by:
Page 2 of 2
ABS Quality Evaluations
Avient Corporation
ISO 13485:2016
Certificate Of Conformance
ANNEX
At Below Facilities:
Validity of this certificate may be confirmed at www.abs-qe.com/cert_validation.
https://www.avient.com/sites/default/files/2020-07/PH -AVIENT LUXEMBOURG - 15608678 - ISO 14001.pdf
POLYONE FRANCE TOSSIAT
43, PLACE DE LA GARE
01250 TOSSIAT
FRANCE
Bureau Veritas Certification France certify that the Management System of the above
organization has been audited and found to be in accordance with the requirements of the
management system standard detailed below:
Standard
ISO 14001:2015
Scope of certification
THE DESIGN AND MANUFACTURE OF COLOUR AND ADDITIVE CONCENTRATES FOR
THERMOPLASTICS
Certification/Recertification Cycle Start Date: 03 May 2023
Subject to the continued satisfactory operation of the organization’s Management System,
this certificate expires on: 02 May 2026
Expiry date of previous cycle: NA
Certification/Recertification Audit date: 08 March 2023
Original Cycle Start Date: 15 July 2011
Certificate n°: FR081968-1
File n°:15608678 Revision date:24 April 2023
Laurent CROGUENNEC - President
Local Office: Bureau Veritas Certification France
Le Triangle de l'Arche - 9 Cours du Triangle - 92937 Paris La Défense
Further clarifications regarding the scope of this certificate the applicability of the management system
requirements may be obtained by consulting the organization.
To check this certificate validity, please use the QR Code.
1/1
https://www.avient.com/idea/securing-supplies-medical-plastic-solutions
During the Covid-19 pandemic, it has become apparent that globalization raises a number of issues.
Avient’s Mevopur™ portfolio and risk mitigation concept can help healthcare manufacturers on the journey to increased security of supply for plastics used in their products.
All four sites are ISO 13485 certified and use a harmonized raw material range as the base for globally available Mevopur standard portfolios and for custom formulations.
https://www.avient.com/company/policies-and-governance/colorant-chromatics-eu-global-email-disclaimers
Colorant Chromatics est une filiale de Avient Corporation.
Colorant Chromatics è una società di Avient Corporation.
Global Locations
https://www.avient.com/news/avient-features-specialty-healthcare-material-solutions-services-mdm-west-2022
Mevopur™ Colorants represent a broad range of color concentrates and formulations, developed specifically for use in today’s complex healthcare applications, which meet or exceed requirements for regulations such as USP Class VI, ISO 10993, USP 661 and ICH Q3D.
To access Avient’s news library online, please visit www.avient.com/news.
Avient Announces Quarterly Dividend...
https://www.avient.com/sites/default/files/2024-09/24 EN 47.pdf
CERTIFICATE
Signed for the certification body:
Eric Louys
Chairman Certification Committee
CERTIFICATE
EN ISO 50001 : 2018
Energy Management System
VINÇOTTE nv
Jan Olieslagerslaan 35, 1800 Vilvoorde, Belgium
This is to certify that Avient
Located at Rue Melville Wilson 2
5330 Assesse
Belgium
has established and maintains an energy management system according the requirements of
EN ISO 50001 : 2018 “Energy Management System” for:
Design and manufacture of colour and additive concentrates, thermoplastic resins and
speciality compounds
This certificate is based on the result of an energy audit documented in the audit report 61231731.
Certificate number: 24 EN 47
Valid from 1 February 2024 to 31 January 2027
Further clarifications regarding the scope of this certificate and the applicability of EN ISO 50001 : 2018
requirements may be obtained by consulting the organization.
This certificate is granted during the Certification Commission of 1 February 2024 and is subject to the
General Regulations of VINÇOTTE nv.
https://www.avient.com/sites/default/files/2023-10/31307-Certificate-20SEP2023.pdf
WITH ADDITIONAL FACILITIES LISTED ON ATTACHED ANNEX)
Certificate Of Conformance
has been assessed by ABS Quality Evaluations, Inc. and found to be in conformance with the requirements set forth by:
Page 2 of 7
ABS Quality Evaluations
Avient Corporation
ISO 9001:2015
Certificate Of Conformance
ANNEX
At Below Facilities:
Validity of this certificate may be confirmed at www.abs-qe.com/cert_validation.
Activity: Manufacture of Colorants for Plastics Activity: Manufacture of thermoplastic compounds
Page 4 of 7
ABS Quality Evaluations
Avient Corporation
ISO 9001:2015
Certificate Of Conformance
ANNEX
At Below Facilities:
Validity of this certificate may be confirmed at www.abs-qe.com/cert_validation.
Activity: Manufacturing, Shipping and Receiving Activity: Compound and supply of thermoplastics for the medical device
industry
Page 5 of 7
ABS Quality Evaluations
Avient Corporation
ISO 9001:2015
Certificate Of Conformance
ANNEX
At Below Facilities:
Validity of this certificate may be confirmed at www.abs-qe.com/cert_validation.
https://www.avient.com/sites/default/files/2021-07/mevopur-pharma-packaging-1-page-case-study.pdf
PHARMACEUTICAL
PACKAGING OEM
V I A L S , B O T T L E S &
C O N T A I N E R S
• Raw materials pre-tested to USP 661.1 and ICHQ3D
guidelines
• Stabilization during molding and sterilization processes for
both opaque and transparent polymer materials
• Certified formulations available globally
• Offered pre-tested raw materials and
produced in an ISO 13485 certified site,
minimizing risk across the pharmaceutical
value chain
• Delivered specialized formulated solutions
to meet stringent pharmaceutical packaging
requirements
• Provided global formulations transferrable
from our three ISO 13485 certified facilities
Mevopur™ Healthcare Concentrates
KEY REQUIREMENTS
WHY AVIENT?
AVIENT SOLUTION
CERTIFICATION + AVAILABILITY
LEARN MORE
© 2021, Avient Corporation, All Rights Reserved
https://www.avient.com/products/polymer-colorants/solid-color-masterbatches/mevopur-custom-colors-and-formulations
https://www.avient.com/sites/default/files/2024-12/ISO9001 2015 Certificate for Shenzhen Plant%282024-2027%29.pdf
MSC Certificate
Place and date: For the issuing office:
Shanghai, 10 October 2024 DNV - Business Assurance
Building 9, No. 1591 Hongqiao Road,
Changning District, Shanghai, China 200336
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
MANAGEMENT SYSTEM
CERTIFICATE
Certificate no.:
3033-2006-AQ-RGC-RvA
Initial certification date:
07 November 2018
Valid:
08 November 2024 – 07 November 2027
This is to certify that the management system of
Polyone - Shenzhen Co., Ltd.
No. 1, Qihang Industry Park, Haoxiang Road, Shajing Town, Baoan, Shenzhen, Guangdong,
China 518104
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:
Development and Manufacture of Masterbatch, Pigment Concentration, Plastisol;
Manufacture of Plastic Compounding Material
http://www.dnv.com/assurance
证书制作地点及日期:
证书认可签发机构:
上海, 2024年10月 10日 DNV - Business Assurance
中国上海市长宁区虹桥路1591号9号楼A座 邮编:
200336 电话: +86 21 32799000
朱海明
管理代表
未履行认证协议中规定条款会导致此证书失效,获证组织必须定期接受监督审核并经审核合格此证书方继续有效。
https://www.avient.com/news/polyone-hires-john-midea-senior-vice-president-global-operations-and-process-improvement
To access PolyOne’s news library online, please go to www.avient.com/news.
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