https://www.avient.com/sites/default/files/2023-10/308659_en_46154.pdf
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. 46154 Validity 12.01.2022 – 11.01.2025 Issue 12.01.2022 Swiss Made Swiss Association for Quality and Management Systems (SQS) Bernstrasse 103, 3052 Zollikofen, Switzerland F.
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/2023-10/ISO 22000 Certificate.pdf
Certificate Number: 255 ISO2P Date First Registered: 03/04/2023 Issued on: 11/04/2023 Valid until: 10/04/2026 Awarded to AVIENT PAKISTAN (PVT) LTD 1A/1, Sector#20, Korangi Industrial Area, Sector 20 Karachi, Pakistan In recognition of the Organization´s Food Safety Management System which complies with : ISO 22000:2018 Food Category : I For the scope of activities described below: Manufacturing & Processing of Polymer Resins & Master batch F-3/22/ A 100 Issue date : 06/2022 Version:03 It is mandatory to carry out the surveillance audit on its time.
https://www.avient.com/sites/default/files/2021-02/mevopur-needle-one-pager-case-study.pdf
H Y P O D E R M I C N E E D L E M A N U FAC T U R E R N E E D L E H U B , C O V E R A N D S H I E L D • Compliance to ISO 6009 color coding for single use hypodermic needle • Biocompatibility of all component materials • Good mechanical and visual properties after sterilization (e.g. ETO / Gamma radiation) • Facilitated 510(k) submission with formulations registered under Device Master File MAF 1833 • Pre-tested raw materials to biocompatibility ISO10993, US and Eu Pharmacopeia, ICH-Q3D extractable metals • Enhanced stability with gamma stabilizing package • Minimized risk of change with change control beyond CAS number level • Ensured uninterrupted supply from multiple ISO 13485-2016 certified sites • MEVOPURTM ISO 6009 Standard / Customized Solutions KEY REQUIREMENTS WHY AVIENT?
https://www.avient.com/sites/default/files/2024-09/31307-Certificate-23AUG2024.pdf
Certificate - ISO 9001 - Avient Corporation - 337726 - 23521672 (1).pdf
https://www.avient.com/sites/default/files/2025-03/65537-Certificate-05MAR2025.pdf
Page 1 of 5 https://abs.zertic.com https://abs.zertic.com ISO 14001:2015ISO 14001:2015 Certificate Of ConformanceCertificate Of Conformance ANNEXANNEX Certificate No: 65537 Avient CorporationAvient Corporation At the below facilities FACILITY NAMEFACILITY NAME FACILITY ACTIVITYFACILITY ACTIVITY ADDRESSADDRESS Avient Corporation Avon Lake Corporate Responsible Care Corporate Support Activities in Sr. Toluca 2000 Toluca Estado de México 50200 Mexico ISO 14001:2015ISO 14001:2015 Certificate Of ConformanceCertificate Of Conformance ANNEXANNEX Certificate No: 65537 Avient CorporationAvient Corporation At the below facilities FACILITY NAMEFACILITY NAME FACILITY ACTIVITYFACILITY ACTIVITY ADDRESSADDRESS Copyright as of the Effective Date, ABS Quality Evaluations, Inc. Unit 3 Dodworth Business Park, Dodworth Barnsley South Yorkshire S75 3SP United Kingdom ISO 14001:2015ISO 14001:2015 Certificate Of ConformanceCertificate Of Conformance ANNEXANNEX Certificate No: 65537 Avient CorporationAvient Corporation At the below facilities FACILITY NAMEFACILITY NAME FACILITY ACTIVITYFACILITY ACTIVITY ADDRESSADDRESS Copyright as of the Effective Date, ABS Quality Evaluations, Inc.
https://www.avient.com/sites/default/files/2024-12/Certificate ISO 22000_Tangerang.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. 7 0 0 1 _1 /A p ri l 2 0 2 2 /V er si o n 2 .0 Certificate P.T. Cibodas 15138 Kecamatan Cibodas, Tangerang 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 Page 1 of 1 Validity 25. 02. 2024 – 24. 02. 2027 Issue 25. 02. 2024 A.Grisard, President SQS F.
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/sites/default/files/2024-07/31307-Certificate-17JUL2024.pdf
Certificate - ISO 9001 - Avient Corporation - 337726 - 23521667 (1).pdf
https://www.avient.com/sites/default/files/2023-09/65799-Certificate-26SEP2023%5B1%5D.pdf
Validity of this certificate may be confirmed at www.abs-qe.com/cert_validation. ISO 9001:2015 The Quality Management System is applicable to: Certificate No: 65799 Certification Date: 01 October 2020 Effective Date: 25 September 2023 Expiration Date: 30 September 2026 Revision Date: 26 September 2023 Dominic Townsend, President DESIGN AND MANUFACTURE OF COLOUR AND ADDITIVE CONCENTRATES, THERMOPLASTIC RESINS AND SPECIALTY COMPOUNDS 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 10 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.