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/company/policies-and-governance/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/2023-11/ISO 9001_EN_Changzhou.pdf
质量管理体系认证认证
Certificate No.:04621Q16559R0S
We hereby certify that the organization:
Fiber-Line Asia Pacific (Changzhou)
Co., Ltd.
Unified social credit code: 91320412MA1NMF5W4P
is in conformity with Quality Management System Standard:
GB/T19001-2016 / ISO9001:2015
The certificate is valid to the following product(s)/service:
Textile (Yarn), Glass Products (Yarn) Coating
Processing
Registration Address/ Physical Address: R&D Workshop 5, No. 8, Lanxiang Road,
West Taihu Science and Technology Industrial Park, Changzhou City, Jiangsu
Province, P.
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/sites/default/files/resources/Tangerang_ISO22000.pdf
C
er
ti
fi
ed
M
anagement System
s
by
Switzerland
Certificate
The SQS herewith attests that the organisation named below has a management system that meets
the requirements of the normative base mentioned.
Cibodas
Kecamatan Cibodas, Tangerang 15138
Indonesia
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. 46391 Validity 25. 02. 2021 – 24. 02. 2024
Issue 30. 06. 2021
Swiss Madesqs.ch
F.
https://www.avient.com/sites/default/files/resources/Jurong_ISO22000.pdf
C
er
ti
fi
ed
M
anagement System
s
by
Switzerland
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 Singapore Pte Ltd
8 Third Chin Bee Road
Jurong Industrial Estate
Singapore 618684
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 Validity 25. 02. 2021 – 24. 02. 2024
Issue 30. 06. 2021
Swiss Madesqs.ch
F.
https://www.avient.com/sites/default/files/2022-12/15719637-22-AVIENT ESPAÑA SL-INGLES.pdf
1/1
Certification/Renovation Audit: 14-10-2022
Original approval date:
- 1
Bureau Veritas Iberia S.L.
Certificate Number:
Certificate expiration date:
Effective date: 31-10-2022
30-10-2025
Expiry date of previous cycle: 30-10-2022
31-10-2016
ES133794
Scope of certification:
MANUFACTURING OF MASTERBATCHES, ADDITIVES
AND COMPOUNDS FOR PIGMENTING THERMOPLASTIC
MATERIALS USED IN FOOD INDUSTRY
ISO 22000:2018
POLIGONO INDUSTRIAL EZCABARTE, C/H, Nº3 - 31194 - ORICAIN -
NAVARRA - ESPAÑA
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 services
STANDARD
Bureau Veritas certification certifies that the Management System has been audited and
found to be in accordance with the requirements of standard:
Awarded to
Certification
2022-12-15T10:52:43+0100
Authenticity and Integrity
2022-12-15T10:53:51+0100
BUREAU VERITAS CERTIFICATION
https://www.avient.com/news/specialty-and-sustainable-healthcare-material-solutions-avient-medtec-china-2023
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 can be customized to meet specific regulatory demands such as USP Class VI, FDA CFR, and ISO 10993.
Versaflex™ HC 2110-57B TPEs comply with ISO 10993-4, ISO 10993-5, and USP Class VI and are suitable for Ethylene Oxide (EtO) sterilization without residue or allergens.
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.