https://www.avient.com/sites/default/files/2025-03/ISO 13485 2025.pdf
View PDF
The SQS herewith attests that the organisation named below has a management system that meets the requirements of
the normative basis mentioned
Normative basis
EN ISO 13485:2016 Medical devices – Quality Management System
Page 1 of 3
Appendix of main certificate H61173
Central function Scope Norm / Revision Reg. no.
Ltd.
30, Hsing Pang Road
33068 Taoyuan Taiwan
Avient Colorants Sweden AB
Järnyxegatan 7
Box 9053
200 39 Malmö
Sweden
Avient Colorants USA LLC
17 Foss Rd.
https://www.avient.com/sites/default/files/2024-03/QF-02 QMS Global Standard Response.PDF
Avient Colorants Sweden AB in Malmoe and Avient Colorants USA LLC in Lewiston, Maine are Medical
Centers of Competence with an external ISO 13485 certification.
Validation
Avient Colorants Sweden AB and Avient Colorants
Lewiston, ME follow the Global Harmonization Task
Force guideline GHTF/SG3/N99-10 to define the
procedure for process validation.
HACCP
Avient Colorants Spain S.A., Avient Colorants
Toluca Mexico, and PolyOne Spain SLU follow the
structure of HACCP (Hazard Analysis and Critical
Control Point) as a system for assessing
compliance to food safety standards.
https://www.avient.com/products/printing-and-marking-inks/colorant-chromatics-low-temperature-inks
PES / PSU / PPSU Colorants
Fluoropolymer Colorants: Colorant Chromatics™
PVdF Colorants: Colorant Chromatics™
https://www.avient.com/products/polymer-colorants/high-temperature-color-concentrates/colorant-chromatics-transcend-premier-healthcare-colorants
Colorant Chromatics™ Transcend™ Premier Healthcare Colorants
Vibrant, Biocompatible Colors
Colorant Chromatics™ Transcend Premier Healthcare Colorants
https://www.avient.com/sites/default/files/2023-10/ISO 13485-2016 cert_expire 28Feb2025_Avient%5B28%5D.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
2
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Certificate
Avient Colorants Singapore Pte Ltd
8 Third Chin Bee Road
Jurong Industrial Estate
618684 Singapore
Singapore
Scope
Administration, Site management, Manufacture,
Laboratory, Procurement, Maintenance,
infrastructure, Warehouse and Transport
Normative base
EN ISO 13485:2016 Medical devices – Quality Management System
Reg. no. 45483 Validity 01. 03. 2022 – 28. 02. 2025
Issue 01. 03. 2022
A.Grisard, President SQS F.
Müller, CEO
sqs.ch Swiss Made
Swiss Association for Quality
and Management Systems (SQS)
Bernstrasse 103, 3052 Zollikofen, Switzerland
https://www.avient.com/sites/default/files/2020-08/colormatrix-select-product-bulletin-1.pdf
ColorMatrix™ Select™ Rapid Color Prototyping Technology
Color creation, selection and supply service for greater control, choice
and speed in color development for injection molded plastic products
WHAT IT IS
With the ColorMatrix™ Select™ system, managing
your own color creation and supply online couldn’t
be easier.
TECHNOLOGY COMPONENTS
Select Rapid Color Prototyping Technology
includes:
Select Color Cell
• Color scanning or matching
• Creation of color plaques
Online Software
• Formulation and price generator
• Web-based processor
Automated Dispenser
• Globally standard base colors
• Consistent production from recipes
HOW IT WORKS
Select allows you to:
• Instantaneously create a new color using
your own standards, spectrophotometer or
colorimeter data, or the software’s
built-in design tools
• Produce small quantities of color masterbatch
for use in validating your color match
• Combine advanced liquid colorants,
cloud-access software and automated
dispensing technology
• Carry out color modeling and rapid iteration
Select also helps you:
• Choose the right color by providing a quick
and cost effective way to model, sample, and
test color options
• Facilitate prototyping and variation testing
PRODUCT BULLETIN
CONVENTIONAL COLOR
DEVELOPMENT PROCESS
Multiple rounds of sampling, trials and
approvals, usually over many weeks.
Typically used
within extrusion, injection molding and blow molding
processes with specific benefits for:
• Manufacturers – Take control of your color supply
• Brand Owners – Efficient online color management
• Designers – Rapid visualization of your color
www.avient.com
Copyright © 2020, Avient Corporation.
https://www.avient.com/investor-center/news/polyone-achieves-responsible-care-certification-american-chemistry-council
ACC) Responsible Care Management System® (RCMS).
In order to receive certification, an ACC member or Partner company must demonstrate conformance to the Responsible Care Management System's comprehensive set of EHS&S requirements, which are validated through an independent, third-party audit process.
https://www.avient.com/investor-center/news/polyone-promotes-joel-rathbun-senior-vice-president-mergers-acquisitions
Rathbun has served as general manager of
Joel's demonstrated business savvy and diverse background as an engineer, banker, M&A leader and general manager make him uniquely qualified for this important, expanded role," said Mr.
https://www.avient.com/news/new-compl-t-pke-materials-offer-additional-sustainable-alternatives-polyamides
This development represents a proactive response to demands from our customers in oil & gas, transportation, and industrial industries looking for next-generation engineered materials with a property retention as low as -22°F for pipes, tubing, fluid management, and more,” said Eric Wollan, general manager, PlastiComp at Avient.
https://www.avient.com/news/polyone-establishes-outdoor-high-performance-solutions-team
Leading the new team is general manager Mike Bradley, a 20-year veteran of PolyOne with 35 years of polymer industry experience, a former sheriff’s deputy in Michigan, and an avid outdoorsman.
Michelle Maniscalco
Marketing Communications Manager, North America
PolyOne Corporation
+1 440-930-1988
michelle.maniscalco@avient.com