https://www.avient.com/news/new-details-specialty-sustainable-technologies-and-services-avient-featured-k-2022
Customer success story with a medical device company using Avient’s Colorant Chromatics™ Transcend™ Bio-compatible Premier Healthcare Colorants: Intended specifically for medical applications, the pre-colored solutions that are fully bio-compatible per ISO 10993 standards helped provide a customer that manufactures medical devices with ultra-high-heat resistance and performance for its orthopedic instruments without compromising safety.
https://www.avient.com/sites/default/files/2021-09/avient2020sustainabilityreport-9-2-21.pdf
Combined,
these facilities have a total of 205 certifications to an ISO or Management System and
standards.
For our sensitive applications, in
addition to ISO9001, we have implemented ISO 13485 and Good Manufacturing
Processes (GMP). 100% of our facilities producing those sensitive applications and
warehouses are GMP audited within a 3–year period.
Our goal in 2021 is to develop processes
and procedures and a position statement on critical customer information, and fully
prioritize the product portfolio in all critical markets/materials.
75
ISO Certified
Facilities
ZERO
Product
Recalls
Major Non-Conformances
at ISO Sites
0
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Sustainability Report | 2020 59Sustainability Report | 2020 59
Management Approach:
Supplier Collaboration
Avient’s value extends not only to consumers through specialty products,
but beyond the boundaries of our own processes and operations.
https://www.avient.com/sites/default/files/2022-09/54139-Certificate-29AUG2022%5B98%5D.pdf
ISO 13485:2016
The Quality Management System is applicable to:
Certificate No: 54139
Certification Date: 04 September 2019
Effective Date: 29 August 2022
Expiration Date: 01 September 2025
Revision Date: 29 August 2022 Dominic Townsend, President
This certificate may be found on the ABS QE Website (www.abs-qe.com).
https://www.avient.com/sites/default/files/2024-06/Avient Melle - 2024.pdf
Bergmann GmbH
Adolf-Dambach-Str. 2-4
76571 Gaggenau
die Einführung und Anwendung eines Managementsystems gemäß
DIN EN ISO 50001:2018
für den Geltungsbereich:
Entwicklung und Produktion von technischen Thermoplasten; an den Standorten
gemäß Anlage.
https://www.avient.com/sites/default/files/2023-09/65567-Certificate-08SEP2023.pdf
ISO 13485:2016
The Quality Management System is applicable to:
Certificate No: 65567
Effective Date: 08 September 2023
Expiration Date: 07 September 2026
Revision Date: 08 September 2023 Dominic Townsend, President
This certificate may be found on the ABS QE Website (www.abs-qe.com).
https://www.avient.com/sites/default/files/2024-02/Sant Andreu_ISO22000.pdf
Martorell no.124
08740 Sant Andreu de la Barca
Spain
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. 46388 Validity 25. 02. 2021 – 24. 02. 2024
Issue 25. 02. 2021
Swiss Made
sqs.ch
F.
https://www.avient.com/sites/default/files/resources/ISO14001.2015PolyOneShanghai%25282018-2021%2529.pdf
Park, Pudong, Shanghai, China, 201203
has been found to conform to the Environmental Management System standard:
ISO 14001:2015
This certificate is valid for the following scope:
Design and Manufacture of Masterbatch
https://www.avient.com/sites/default/files/308837_en_46388.pdf
Martorell no.124
08740 Sant Andreu de la Barca
Spain
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. 46388
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/2024-04/CCG Application Snapshot_Endoscope.pdf
Surgical instrument oem
S U RG I C A L
I N S T RU M E N T O E M
E N D O S C O P E C O M P O N E N T S
• Functional differentiation
• ISO 10993 compliance
• Excellent resistance to steam sterilization
• Excellent chemical resistance
• Delivered a variety of bright, distinguishing color
choices for functional differentiation
• Minimized color deviation
• Provided a biocompatible solution
• Offered low MOQ with flexible supply
Transcend Premier PPSU Healthcare Pre-
colored Solutions
KEY REQUIREMENTS
WHY AVIENT?
https://www.avient.com/sites/default/files/2020-07/versaflex-hc-syringe-plunger-spanish.pdf
Versaflex HC - Syringe Plunger - Spanish
FABRICANTE DE
JERINGAS
É M B O L O D E J E R I N G A
D E S E C H A B L E
• Cumplir con las normas USP VI e ISO 10993-4,5
• Esterilización con gamma y EtO
• Rendimiento de sellado a largo plazo
• Bajo coeficiente de fricción (COF)
• Rendimiento uniforme en jeringas de diferentes diámetros
• Ofreció una solución formulada que cumple
con los requerimientos rigurosos de una
aplicación médica
• Mejoró la continuidad del suministro global
• Aumentó la eficiencia del proceso al
sustituir el material termoestable anterior
con un TPE
Versaflex™ HC 2110-57B
REQUERIMIENTOS CLAVE
¿POR QUÉ AVIENT?