https://www.avient.com/sites/default/files/2024-04/ISO CERT. 9001-2015.pdf
This is to certify that
Fiber-Line, LLC
280 Performance Drive SE, Hickory, North Carolina 28602 USA
Quality Management System
ISO 9001:2015
Manufacture of textile components to cable manufacturers.
Certificate No.: CERT-0116814 Original Certification Date: November 24, 2010
File No.: 1616267 Certification Effective Date: April 1, 2021
Issue Date: March 30, 2021 Certificate Expiry Date: March 31, 2024
________________________________________________________________________________
ISO 9001
Registered by:
QMI-SAI Canada Limited (SAI Global), 20 Carlson Court, Suite 200, Toronto, Ontario M9W 7K6 Canada.
https://www.avient.com/sites/default/files/2023-12/ISO 9001 Englewood CO.pdf
PLATINUM REGISTRATION INC.
1040 South Gaylord Street, Suite 71, Denver, CO 80209
www.platinumregistration.com | info@platinumregistration.com
Polystrand, Inc.
8375 Highfield Parkway,
Englewood, CO, 80112
Is certified by PLATINUM REGISTRATION as a company that has developed, implemented
and maintains a quality management system that conforms to the requirements of the following
International Standards:
ISO 9001:2015
(Requirements not applicable:8.5.5 Post-delivery activities.)
Certificate Number: 13132875
Certified Since: November 19, 2019 *
Certificate Approval Date (Date Granted, Reduced, Extended, or Renewed): October 12, 2022
Current Certification Cycle Start Date: November 19, 2022
Current Certification Cycle Expiration Date: November 18, 2025
Rev: B
This certification is subject to the organization maintaining its management system to the requirements of ISO
9001:2015 as well as the requirements of Platinum Registration, Inc.
https://www.avient.com/products/polymer-colorants/solid-color-masterbatches/remafin-ep-white-colorants
ISO 10993-1, USP and (class VI), USP , European Pharmacopeia monographs 3.1.3 and 3.1.5, ICH Q3D and USP and evaluations reduce risk of non-compliance during regulatory submission
https://www.avient.com/resource-center/services/product-carbon-footprint-pcf-calculator
Our PCF calculator is third-party certified by TÜV Rheinland and aligns with the ISO 14067:2018 Standard for quantifying and reporting the carbon footprint of a product.
https://www.avient.com/news/avient-launches-medical-tpe-grades-formulated-without-animal-derivatives
All eight grades in the new series are also ISO 10993-4 and -5, REACH SVHC, and RoHS compliant.
https://www.avient.com/news/polyone-features-more-materials-approach-medical-devices-mdm-west-2020
OnColor™ HC Colorants for Healthcare: color concentrates developed to meet or exceed USP Class VI and ISO 10993 and formulated without heavy metals, phthalates and BPA or other requirements as specified
https://www.avient.com/news/polyone-launches-neu-view-technology-radiopaque-translucent-catheters
They are available in certified USP Class VI and ISO 10993 compositions.
https://www.avient.com/news/polyone-develops-new-silicone-alternative-tpe-medical-tubing
Commercially available in the United States, it has been submitted for USP VI and ISO 10993-4,5 certifications.
https://www.avient.com/idea/medical-stoppers-improved
This formulation meets the requirements of the ISO 15759 standard for medical infusion equipment, and can be steam autoclaved using temperatures up to 121°C.
https://www.avient.com/idea/changing-regulations-ivdr
Dedicated global technical centers and ISO 13485 certified manufacturing sites round out the service offer and provide consistent support for diagnostic devices.