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/2022-07/Lewiston 308872_en_13485_21%5B43%5D.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. 45484 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.
https://www.avient.com/sites/default/files/2024-07/Colorants _ Additives for Appliances Brochure.pdf
SUSTAINABILITY
Avient’s color and additive manufacturing sites
comply with ISO standards such as ISO 9001:2015
QMS, ISO 14001:2015 Environmental Management
System and ISO 45001:2018*.
EC) 1907/2006 and amendments)
• UL94 file for MB (QMQS.E73454) and formulations
(QMQS.E103015)
• “Toys declaration” Directive 2009/48/EC
• Waste Electrical & Electronic Equipment (WEEE)
* Contact us for more detailed information about our ISO certifications.
https://www.avient.com/industries/healthcare/drug-delivery-systems
Custom formulations can meet specific opacities, sealing requirements, impact performance, and align with ISO 6009 color standards.
Custom formulations can meet specific opacities, sealing requirements, impact performance, and align with ISO 6009 color standards.
https://www.avient.com/news/‘future-proof’-pharma-packaging-avient-launches-new-regulatory-compliant-mevopur-amber-masterbatches
Produced under rigorous cGMP and medical manufacturing protocols, the new amber color concentrates are made in three dedicated EN ISO 13485-2016 registered facilities using only medical-grade ingredients.
They are formulated without animal-derived substances and phthalates, and have been pre-tested for compliance with:
• ISO 10993-1 and USP parts , (including class VI)
• European Pharmacopoeia, monograph 3.1.15
• USP and
• elemental analysis, as per ICH Q3D
https://www.avient.com/sites/default/files/2024-02/Santa Clara_ISO22000.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 base mentioned.
Plasticos 28
Santa Clara Coatitla
55540 Ecatepec de Morelos, Estado de México
Mexico
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. 46389 Validity 25. 02. 2021 – 24. 02. 2024
Issue 30. 06. 2021
Swiss Made
sqs.ch
F.
https://www.avient.com/resources/safety-data-sheets?page=6455
HAZEL ISO FIX DOOR V3
MAUVE DOOR, ISO FIX COVER V3
Certificate of Analysis (COA) - labeled as "Material"
https://www.avient.com/news/avient-launches-t-v-rheinland-certified-carbon-calculator-scope-3-emission-goals
Avient's PCF Calculator adheres to the globally recognized ISO 14067:2018 standard for calculating Product Carbon Footprint and has obtained additional third-party certification through TÜV Rheinland for ISO 14067 compliance.
https://www.avient.com/news/avient-announces-expansion-neusoft-tpu-manufacturing-china-medtec-china-2024-enhancing-service-apac-customers
They are also certified to meet biocompatibility requirements for ISO 10993 and USP Class VI standards.
Avient's Suzhou facility operates under ISO 13485 quality management system certification, complying with the leading standards in medical device manufacturing.
https://www.avient.com/sites/default/files/2025-03/65536-Certificate-05MAR2024.pdf
Certificate No: 65536
Certification structure: MULTI-SITEMULTI-SITE
Certification Date: 29 SEP 2023
Effective Date: 27 FEB 2025
Expiration Date: 27 SEP 2026
Revision Date: 05 MAR 2025
Dominic Townsend, PresidentDominic Townsend, President
Copyright as of the Effective Date, ABS Quality Evaluations, Inc.
For certificates issued in the People’s Republic of China information may also be verified on the Certification and Accreditation
Administration of the People’s Republic of China’s website (www.cnca.gov.cn).
For certificates issued in the People’s Republic of China information may also be verified on the Certification and Accreditation
Administration of the People’s Republic of China’s website (www.cnca.gov.cn).