https://www.avient.com/sites/default/files/2024-12/ISO14001_English_Suzhou ColorMatrix.pdf
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ENVIRONMENTAL MANAGEMENT,_,
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Certificate No. 00124E30295R4S/3200
We hereby certify that
Color Matrix Plastic Colorants (Suzhou) Co., Ltd
Business Registration Number: 91320505799067336K
Registered/ Operation Address: 13 Plant, No.855, Zhujiang Road, Suzhou New District, Jiangsu Province, China
by reason of its
Environmental Management System
has been awarded this certificate for compliance with the standard
ISO 14001:2015
The Environmental Management System Applies in the following area:
Production and Related Management Activities of Plastic Colorant & Additive (UV Blockers, Anti-Aging,Anti-Oxidation)
Certified since: June 6, 2012 Valid from: January 17, 2024 Valid until: January 7, 2027
the expiry date of last certification cycle: January 7, 2024 the date ofrecertification 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)
https://www.avient.com/company/policies-and-governance/cpsia-information
The timetable for testing, certification and enforcement as outlined on the CPSC web site (see link in adjacent column), generally requires compliance in advance of testing and certification.
PDI is accredited under ISO 17025 by A2LA (the American Association for Laboratory Accreditation) to perform testing as an independent laboratory body.
Global ISO Certificate Library
https://www.avient.com/sites/default/files/2024-03/Global Supplier Quality Manual_2024.pdf
Minimum requirements are adopted from the ISO 9001
standard.
Avient requires a Certification of Analysis (COA) and supplier specification documents for every
shipment of raw material.
Avient categorization
for a “supplier”
FDA Food & Drug Administration
IATF International Automotive Task Force
Interested Party Term referenced in ISO 9001.
https://www.avient.com/sites/default/files/2022-06/Malmoe 308840_en_13485_22.pdf
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The SQS herewith attests that the organisation named below has a management system that meets
the requirements of the normative basis mentioned.
Normative base
EN ISO 13485:2016 Medical devices –
Quality Management System
Reg. no. 37081 Validity 01.03.2022 – 28.02.2025
Issue 01.03.2022
Swiss Made
Swiss Association for Quality
and Management Systems (SQS)
Bernstrasse 103, 3052 Zollikofen, Switzerland
sqs.ch
F.
https://www.avient.com/sites/default/files/resources/Ahrensburg_ISO50001.pdf
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Sw
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Certificate
The SQS herewith attests that the organisation named below has a management system that meets
the requirements of the normative base mentioned.
Avient Colorants Germany GmbH
Kornkamp 50
22926 Ahrensburg
Germany
Scope
Production of Color- and Additives Concentrates,
Compounds and Foaming Agents
Normative base
ISO 50001:2018 Energy Management System
Reg. no. 46090 Validity 20. 01. 2021 – 19. 01. 2024
Issue 12. 04. 2021
Swiss Made
Swiss Association for Quality
and Management Systems (SQS)
Bernstrasse 103, 3052 Zollikofen, Switzerland
sqs.ch
F.
https://www.avient.com/sites/default/files/2024-01/308699_en_46089.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 Germany GmbH
Hohenrhein 1
56112 Lahnstein
Germany
Scope
Production of Color Concentrates and Compounds
Normative base
ISO 50001:2018 Energy Management System
Reg. no. 46089
Page 1 of 1
Validity 17. 12. 2023 – 16. 12. 2026
Issue 17. 12. 2023
A.Grisard, President SQS F.
https://www.avient.com/company/policies-and-governance-0/avients-human-rights-policy
Global ISO Certificate Library
https://www.avient.com/company/policies-and-governance/avients-position-water-stewardship
Global ISO Certificate Library
https://www.avient.com/sites/default/files/2020-10/neu-quality-commitment.pdf
In the event of a conflict between this Quality
Commitment and any mutually agreed specifications or quality agreement that is executed by NEU,
the mutually agreed specifications or signed quality document shall control.
1.0 PRODUCT DESCRIPTION
Thermoplastic material in pellet form.
2.0 TEST METHODS
NEU test methods are modeled after ASTM testing standards, where applicable.
3.0 OPERATIONAL DEFINTIONS
3.1 Lot (Batch): Material manufactured at one time.
3.2 Blend: No more than three lots of a specific raw material, combined together to form a
homogeneous mixture.
3.2.1 Full lot tractability of non-proprietary formulations will be reflected on the COC
3.3 Certification: “Certificate of Conformance” or “Certificate of Analysis” based material
requirements
3.4 Certificate of Analysis: Document containing information that the product conforms to
the established Product Specifications.
3.5 Certificate of Conformance: Document containing confirmation that the product
conforms to the defined formulation.
3.6 Finished Product Form: Finished product shape (Cylindrical, Spherical)
3.7 Product Specification: the product specifications that are contained in a written
document signed by NEU, or if such document does not exist, the Certificate of Analysis
or Certificate of Conformance issued by NEU.
4.0 PACKAGING
4.1 Standard product packaging options include:
4.1.1 Drum
4.1.2 Gaylord
4.1.3 Pail
4.1.4 Individual bag in box
Approved
Plant/Local : Reference Document
Document #: DOC-10815 Revision: 3
Document
Owners:
Dean Clark Effective Date: Oct 29, 2020
Title: NEU Quality Commitment
Page 2 of 4
Only the electronic version of this document in ETQ is the controlled version of the document.
as applicable)
4.2.2 Customer Description
4.2.3 Manufacturer’s Product Code
4.2.4 Manufacturer's Lot Number
4.2.5 Quantity and Units (Example 25 lbs.)
4.2.6 Company Name
4.2.7 Date of Manufacture
4.2.8 Expiration Date (as applicable)
5.0 SUPPORTING DOCUMENTATION
5.1 Certification: Each shipment of product will be accompanied by a Certification that, at
the time of shipment, the material conforms to the Product Specifications.
5.1.1 Certification document will include:
5.1.1.1 Customer Part Number
5.1.1.2 Customer Purchase Order Number
5.1.1.3 Customer Material Description
5.1.1.4 Manufacturer's Lot Number
5.1.1.5 Total quantity shipped (with units)
5.1.1.6 Test values (as applicable)
5.1.2 Certification will be sent with each product shipment, addressed to the
Customer’s shipping location and/or electronically sent to appropriate Customer
contact.
5.1.3 The Certification document may contain test values conducted by NEU on the
product for those characteristics listed under certification.
5.2 Safety Data Sheets: A Safety Data Sheet will be made available upon request or may
be available on NEU’s website.
In the event that
the NEU determines that it is the root cause of the Customer complaint, a corrective
action will be issued, and preventive actions will be developed to address the root
cause.
10.0 MANAGEMENT OF SUPPLIERS
10.1 NEU will maintain and ensure oversight and monitoring of applicable suppliers in
accordance with the requirements of ISO 13485 Quality Management System.
11.0 TRACABILITY, RECORDS & RETENTION
11.1 NEU is responsible for establishing and maintaining controlled documentation of
product and raw material component traceability during all stages of production and
shipment.
11.2 An electronic record of the manufacturing conditions and raw materials (vendor ID and
lot number) used to manufacture each batch is retained and preserved for a period of at
least 7 years from the manufacture date or as specified by applicable Regulatory
Requirements.
11.3 An electronic record of the Customer purchase order and NEU sales order confirmation
will be retained and for a period of at least 7 years from order acceptance date.
11.4 A representative sample of the product manufactured will be retained for a period of at
least 1 year from manufacture date.
12.0 EXPIRATION
12.1 NEU’s obligations contained in this Quality Commitment will automatically expire if the
Customer does not purchase product from NEU for a period of one year.
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.