https://www.avient.com/idea/securing-supplies-medical-plastic-solutions
For the plastics used in these medical applications, this can mean compliance with the relevant chapters of the International Organization for Standardization (ISO), the United States Pharmacopeia Class VI (USP VI) the European Pharmacopeia (EP 3.1), and the International Conference on Harmonization (ICH Q3D) standards and guidelines.
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.
The raw materials are pre-tested to the relevant chapters of ISO 10991, USP 661, USP Class VI, EP 3.1 and to the ICH Q3D guidelines to help manufacturers increase the certainty of regulatory compliance for their devices and packaging.
https://www.avient.com/sites/default/files/2021-11/0514-02-dec2021.pdf
Avon Lake, OH
for technical competence in the field of
Chemical Testing
This laboratory is accredited in accordance with the recognized International Standard ISO/IEC 17025:2017
General requirements for the competence of testing and calibration laboratories.
This accreditation demonstrates
technical competence for a defined scope and the operation of a laboratory quality management system
(refer to joint ISO-ILAC-IAF Communiqué dated April 2017).
Presented this 28th day of February 2020.
_______________________
Vice President, Accreditation Services
For the Accreditation Council
Certificate Number 0514.02
Valid to December 31, 2021
Revised September 21, 2021
0514-02s
SCOPE OF ACCREDITATION TO ISO/IEC 17025:2017
Test Method or Standard:
Test Description:
0514-02c
https://www.avient.com/sites/default/files/resources/0514_02%2520PDI%2520ISO17025%2520Chemical_Extension%2520Cert2019.pdf
Avon Lake, OH
for technical competence in the field of
Chemical Testing
This laboratory is accredited in accordance with the recognized International Standard ISO/IEC 17025:2005
General requirements for the competence of testing and calibration laboratories.
This accreditation demonstrates
technical competence for a defined scope and the operation of a laboratory quality management system
(refer to joint ISO-ILAC-IAF Communiqué dated April 2017).
Presented this 30th day of March 2018.
_______________________
Vice President, Accreditation Services
For the Accreditation Council
Certificate Number 0514.02
Valid to December 31, 2019
Revised October 08, 2019
0514-02.pdf
SCOPE OF ACCREDITATION TO ISO/IEC 17025:2005
Test Method or Standard:
Test Description:
0514-02c.pdf
https://www.avient.com/news/avient-feature-specialty-technologies-and-services-healthcare-mdm-west-2023
Manufactured across a global network of ISO 13485 facilities, they meet or exceed requirements for regulations such as USP Class VI, ISO 10993, USP 661, and ICH Q3D.
Like other Mevopur formulations, they are manufactured in dedicated ISO 13485 facilities and supported by testing to ISO 10993-1, USP, European Pharmacopeia, and ICH Q3D guidelines.
They are offered in pre-colored or concentrate form in a range of vivid opaque and transparent colors that are fully bio-compatible per ISO 10993 standards to provide ultra-high-heat resistance and performance without compromising safety.
https://www.avient.com/sites/default/files/2023-11/AS9100 REV D_Hatfield PA.pdf
AS9100 Certication DEKRA
CERTIFICATE
Certificate Number: 131789.01
The Aerospace Quality Management System and implementation of:
Fiber-Line, LLC
With Central Functions At:
3050 Campus Drive
Hatfield, PA 19440
United States
The certification has been performed in accordance with the requirements of AS9104/1:2012, including its
implementation, and meets the requirements of the standard:
AS9100D
(Based on and including ISO 9001:2015)
Scope:
The value added design and development of synthetic fiber products for
use in public and private sectors.
Certification Structure: Single
Certificate Expiry Date: April 26, 2024
Certificate Issue Date: April 27, 2021
Certified Since: April 27, 2018
Dr.
Onus
Managing Director
DEKRA Certification, Inc.
1120 Welsh Road, Suite 210
North Wales, PA 19454 USA
(215) 997-4519
www.dekra.us/en/audits
DEKRA Certification Inc. is an accredited Aerospace Registration Management Program Certification Body, under the ICOP scheme.
https://www.avient.com/sites/default/files/resources/Polyone%2520Barbastro_ISO%25209001_2015%2520EXP%25202021.pdf
Industrial Valle del Cinca
s/n Apartado 18
22300 Barbastro, Huesca
Spain
has been assessed by ABS Quality Evaluations, Inc. and found to be in conformance with the requirements set forth by:
ISO 9001:2015
The Quality Management System is applicable to:
DEVELOPMENT, PRODUCTION & DISTRIBUTION OF TECHNICAL THERMOPLASTICS.
This certificate may be found on the ABS QE Website (www.abs-qe.com).
Validity of this certificate may be confirmed at www.abs-qe.com/cert_validation.
https://www.avient.com/sites/default/files/resources/Polyone%2520Barbastro_ISO%252014001_2015_EXP%25202021_0.pdf
Industrial Valle del Cinca
s/n Apartado 18
22300 Barbastro, Huesca
Spain
has been assessed by ABS Quality Evaluations, Inc. and found to be in conformance with the requirements set forth by:
ISO 14001:2015
The Environment Management System is applicable to:
DEVELOPMENT, PRODUCTION & DISTRIBUTION OF TECHNICAL THERMOPLASTICS.
This certificate may be found on the ABS QE Website (www.abs-qe.com).
Validity of this certificate may be confirmed at www.abs-qe.com/cert_validation.
https://www.avient.com/sites/default/files/2022-12/15719637-22-AVIENT ESPAÑA SL-INGLES.pdf
1/1
Certification/Renovation Audit:Certification/Renovation Audit: 14-10-202214-10-2022
Original approval date:Original approval date:
-- 11
Bureau Veritas Iberia S.L.Bureau Veritas Iberia S.L.
Certificate Number:Certificate Number:
Certificate expiration date:Certificate expiration date:
Effective date:Effective date: 31-10-202231-10-2022
30-10-202530-10-2025
Expiry date of previous cycle:Expiry date of previous cycle: 30-10-202230-10-2022
31-10-201631-10-2016
ES133794ES133794
Scope of certification:Scope of certification:
MANUFACTURING OF MASTERBATCHES, ADDITIVESMANUFACTURING OF MASTERBATCHES, ADDITIVES
AND COMPOUNDS FOR PIGMENTING THERMOPLASTICAND COMPOUNDS FOR PIGMENTING THERMOPLASTIC
MATERIALS USED IN FOOD INDUSTRYMATERIALS USED IN FOOD INDUSTRY
ISO 22000:2018ISO 22000:2018
POLIGONO INDUSTRIAL EZCABARTE, C/H, Nº3 - 31194 - ORICAIN -
NAVARRA - ESPAÑA
AVIENT ESPAÑA, S.L.AVIENT ESPAÑA, S.L.
C/ Valportillo Primera 22-24, Edificio Caoba, 28108 Alcobendas - Madrid, España
This certificate is valid, subject to the general and specific terms and conditions of certification servicesThis certificate is valid, subject to the general and specific terms and conditions of certification services
STANDARDSTANDARD
Bureau Veritas certification certifies that the Management System Bureau Veritas certification certifies that the Management System has been audited andhas been audited and
found to be in accordance with found to be in accordance with the requirements of standard:the requirements of standard:
Awarded toAwarded to
CertificationCertification
https://e-cer.bureauveritas.com/WJLVJDYG9LKV98RP6JCHF8NPSKES0NHDXDPLOWOT1TB290DE4LNZC0JCBAI2BVWEAZ1GJWC8BMDC2TXFBGVDXP3YXG0JLAVMFN3HLEWBLUWJGXCY5PAJ8QKKSTVJYSZ9M9
https://e-cer.bureauveritas.com/WJLVJDYG9LKV98RP6JCHF8NPSKES0NHDXDPLOWOT1TB290DE4LNZC0JCBAI2BVWEAZ1GJWC8BMDC2TXFBGVDXP3YXG0JLAVMFN3HLEWBLUWJGXCY5PAJ8QKKSTVJYSZ9M9
https://e-cer.bureauveritas.com/WJLVJDYG9LKV98RP6JCHF8NPSKES0NHDXDPLOWOT1TB290DE4LNZC0JCBAI2BVWEAZ1GJWC8BMDC2TXFBGVDXP3YXG0JLAVMFN3HLEWBLUWJGXCY5PAJ8QKKSTVJYSZ9M9
https://e-cer.bureauveritas.com/WJLVJDYG9LKV98RP6JCHF8NPSKES0NHDXDPLOWOT1TB290DE4LNZC0JCBAI2BVWEAZ1GJWC8BMDC2TXFBGVDXP3YXG0JLAVMFN3HLEWBLUWJGXCY5PAJ8QKKSTVJYSZ9M9
https://e-cer.bureauveritas.com/WJLVJDYG9LKV98RP6JCHF8NPSKES0NHDXDPLOWOT1TB290DE4LNZC0JCBAI2BVWEAZ1GJWC8BMDC2TXFBGVDXP3YXG0JLAVMFN3HLEWBLUWJGXCY5PAJ8QKKSTVJYSZ9M9
https://e-cer.bureauveritas.com/WJLVJDYG9LKV98RP6JCHF8NPSKES0NHDXDPLOWOT1TB290DE4LNZC0JCBAI2BVWEAZ1GJWC8BMDC2TXFBGVDXP3YXG0JLAVMFN3HLEWBLUWJGXCY5PAJ8QKKSTVJYSZ9M9
https://e-cer.bureauveritas.com/WJLVJDYG9LKV98RP6JCHF8NPSKES0NHDXDPLOWOT1TB290DE4LNZC0JCBAI2BVWEAZ1GJWC8BMDC2TXFBGVDXP3YXG0JLAVMFN3HLEWBLUWJGXCY5PAJ8QKKSTVJYSZ9M9
2022-12-15T10:52:43+0100
Authenticity and Integrity
2022-12-15T10:53:51+0100
BUREAU VERITAS CERTIFICATION
https://www.avient.com/sites/default/files/2021-04/shanghai-9001.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.
TEL:+31(0)102922689. www.dnvgl.com/assurance
Certificate No:
7071-1998-AQ-RGC-RvA
Initial certification date:
28 April, 1998
Valid:
29 March, 2021 – 29 March, 2024
This is to certify that the management system of
PolyOne-Shanghai, China
No. 88, Guo Shou Jing Road, Z.
Park, Pudong, Shanghai China, 201203
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 Masterbatch
Certificate No: 7071-1998-AQ-RGC-RvA
Place and date: Shanghai, 19 March, 2021
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
CNSUZ3-SUH9-20240123104552
QUALITY MANAGEMENT SYSTEM\,,
CERTIFICATE
Certificate No. 00124Q30506R5S/3200
We hereby certify that
Color Matrix Plastic Colorants (Suzhou) Co., 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.
Please access www.cqc.com.cn for checking validity of the certificate.
This certificate and its relevant information can query in the website of Certification and Accreditation Administration of
the People's Republic of China ( www.cnca.gov.cn)