PLITEK® Achieves Recertification for ISO 13485:2016 and ISO 9001:2015 Quality Standards

PLITEK®

35 Piper Lane

Prospect Heights, IL

April 9 th , 2025

PLITEK® Achieves Recertification for ISO 13485:2016 and ISO 9001:2015 Quality Standards

Prospect Heights, IL – April 9, 2025 — PLITEK® is pleased to announce its successful ISO 13485:2016 and ISO 9001:2015 recertification, reaffirming the company’s long-standing commitment to quality, process control, and regulatory compliance in precision die-cutting and converting manufacturing.  

The ISO 13485:2016 certification highlights PLITEK®’s dedication to meeting stringent quality management system (QMS) requirements specific to medical device manufacturing. This internationally recognized standard ensures consistent quality, production and delivery of medical device components under strict regulatory control. PLITEK®'s ISO Class 8 cleanroom environments play a key role in supporting these quality standards, enabling the controlled manufacturing of converted and die cut components.

The ISO 9001:2015 certification further validates PLITEK®’s commitment to delivering high-quality products and services across a broad range of industries. As a globally recognized standard, ISO 9001:2015 provides a robust framework for effective quality management practices across all business operations.

These recertifications demonstrate PLITEK®’s ongoing investment in quality systems and its commitment to delivering consistent, innovative, and compliant manufacturing solutions to its customers.

With over 50 years of experience, PLITEK® is a vertically integrated manufacturer offering converting solutions — from engineering support and prototyping to ISO Class 8 cleanroom production and high-volume manufacturing. Leveraging advanced die-cutting technologies, material expertise, and scalable processes, PLITEK® supports customers across the medical, automotive, industrial, electronics, consumer, and other markets.

Plitek’s converting capabilities include:

To learn more about PLITEK®’s manufacturing capabilities visit www.plitek.com .