C e rt if ie d M an ag ement System s by Sw itze rla nd Certificate 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.

C e rt if ie d M an ag ement System s by Sw itze rla nd 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.

View PDF The SQS herewith attests that the organisation named below has a management system that meets the requirements of the normative base mentioned. 7 0 0 1 _1 /A p ri l 2 0 2 2 /V er si o n 2 .0 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.

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.

Homepage // News Center // Avient Achieves Reexamination Certificate for Dyneema® Cut-Resistant Yarn Patent The certificate confirms the patentability of 73 claims as amended or newly added in U.S. The reexamination certificate serves as a testament to the ingenuity of our cut-resistant yarn technology and the robustness of its patent protection.

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.

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.

C e rt if ie d M an ag ement System s by Sw itze rla nd Certificate The SQS herewith attests that the organisation named below has a management system that meets the requirements of the normative base mentioned. Martorell no.124 08740 Sant Andreu de la Barca Spain 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. 46388 Validity 25. 02. 2021 – 24. 02. 2024 Issue 25. 02. 2021 Swiss Made sqs.ch F.

View PDF The SQS herewith attests that the organisation named below has a management system that meets the requirements of the normative base mentioned. 7 0 0 1 _1 /A p ri l 2 0 2 2 /V er si o n 2 .0 Certificate Avient Colorants Spain S.A. Martorell no.124 08740 Sant Andreu de la Barca Spain 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. 46388 Page 1 of 1 Validity 25. 02. 2024  – 24. 02. 2027 Issue 25. 02. 2024  A.Grisard, President SQS F.

C e rt if ie d M an ag ement System s by Sw itze rla nd 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 Made sqs.ch F.