https://www.avient.com/sites/default/files/resources/PolyOne%2520Standard%2520Quality%2520Response_2016_6_9.pdf
ISO/TS 16949 certifications (7) are
site-specific.
ISO certificates can be found at
www.polyone.com under Quick Links > ISO
List.
Yes, as part of the ISO 9001 documentation.
8.
https://www.avient.com/sites/default/files/2024-09/24 EN 47.pdf
CERTIFICATE
Signed for the certification body:
Eric Louys
Chairman Certification Committee
CERTIFICATE
EN ISO 50001 : 2018
Energy Management System
VINÇOTTE nv
Jan Olieslagerslaan 35, 1800 Vilvoorde, Belgium
This is to certify that Avient
Located at Rue Melville Wilson 2
5330 Assesse
Belgium
has established and maintains an energy management system according the requirements of
EN ISO 50001 : 2018 “Energy Management System” for:
Design and manufacture of colour and additive concentrates, thermoplastic resins and
speciality compounds
This certificate is based on the result of an energy audit documented in the audit report 61231731.
Certificate number: 24 EN 47
Valid from 1 February 2024 to 31 January 2027
Further clarifications regarding the scope of this certificate and the applicability of EN ISO 50001 : 2018
requirements may be obtained by consulting the organization.
https://www.avient.com/sites/default/files/2022-04/MEVOPUR LQ for Silicone Elastomers.pdf
Customized color solutions are
available on request
• Production under ISO 13485 / GMP quality
system with change control management
• Fingerprinting of raw materials and routine
batch testing
• Extractability evaluated in hexane, isopropanol,
and water according
to ISO 10993 part 18
REGULATORY SUPPORT
• Raw materials are pre-tested to biologically-
evaluated raw materials using ISO 10993-1 and
USP chapters , Class VI
• DMF/MAF documentation filed with the FDA
for all standard colors
APPLICATIONS
MEVOPUR LQ formulations can be applied
in demanding applications including:
• Medical devices such as catheter tubing
& connectors, syringe tips, and needleless
connectors
• Skin contact devices such as wearables
or soft-touch surfaces of medical devices
PRODUCT BULLETIN
MEVOPUR™-LQ YELLOW (PMS1205C)
Product Code FZ1M415005
MEVOPUR™-LQ TRANS YELLOW
Product Code FZ1M415006
MEVOPUR™-LQ BLUE (PMS292C)
Product Code FZ5M415008
MEVOPUR™-LQ TRANS BLUE
Product Code FZ5M415009
MEVOPUR™-LQ RED (PMS198C)
Product Code FZ3M415008
MEVOPUR™-LQ TRANS RED
Product Code FZ3M415009
MEVOPUR™-LQ GREEN (PMS346C)
Product Code FZ6M415008
MEVOPUR™-LQ TRANS GREEN
Product Code FZ6M415009
MEVOPUR™-LQ VIOLET (PMS2655C)
Product Code FZ4M415003
MEVOPUR™-LQ TRANS VIOLET
Product Code FZ4M415004
CUSTOM-MADE Individual options
Customized colors
are also available to
meet your needs,
please contact us.
Avient products have not been designed for nor are they promoted or intended for use in:
(a) medical devices categorized by either the United States Food and Drug Administration (FDA) or the International Standards Organization (ISO) as an “implant” device; or “Permanent” as defined under
US Pharmacopoeia (USP) or ISO standards; or
(b) active implantable medical devices as defined in EU Directive 90/385/EEC as amended; or
(c) medical devices for “Long Term” use as defined in EU Directive 93/42/EEC as amended.
https://www.avient.com/sites/default/files/2024-03/Global Supplier Quality Manual_2024.pdf
Minimum requirements are adopted from the ISO 9001
standard.
This document is property of Avient
3.0 Supplier Management
3.1 Supplier Quality Management System
Avient expects its supply base to maintain a certified QMS at all of its locations and those of its
affiliated companies in accordance with the requirements of ISO 9001, ISO 13485, or IATF 16949
(depending on supplier commodity), as applicable.
Avient categorization
for a “supplier”
FDA Food & Drug Administration
IATF International Automotive Task Force
Interested Party Term referenced in ISO 9001.
https://www.avient.com/sites/default/files/2023-11/ISO 14001_CN_Changzhou.pdf
https://www.avient.com/sites/default/files/2023-11/ISO 9001_EN_Changzhou.pdf
https://www.avient.com/sites/default/files/2023-11/ISO 9001_CN_Changzhou.pdf
https://www.avient.com/sites/default/files/2021-11/suzhou-colormatrix-iso-900185.pdf
https://www.avient.com/sites/default/files/2023-06/ISO 45001 Suzhou - GLS.pdf
https://www.avient.com/sites/default/files/2024-07/31307-Certificate-11JUL2024.pdf
Certificate - ISO 9001 - Avient Corporation - Avon Lake, OH - 337726 - 23521667 (3).pdf