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Quality Built Into Every Process

PLITEK® is fully committed to serving our customers at a level which meets or exceeds their expectations. We do this by maintaining compliance to the ISO 9001 & ISO 13485 standards while pursuing measurable objectives and regularly reviewing our quality system for suitability and effectiveness in an effort to continuously improve our business.

Quality has always been a driving force at PLITEK®. As one of the first companies in Illinois to adopt the ISO 9001 standard back in 1992, PLITEK® maintains a robust and mature Quality Management System that gives our customers the confidence that they will receive consistent, high-quality products each and every time. PLITEK® is certified to ISO 9001:2015 and ISO 13485:2016 standards while in the process of implementing and gaining compliance to Health Canada regulations. We follow advanced product quality planning (APQP) processes to lower manufacturing risk and exceed your quality standards.

We work closely with our customers to ensure our understanding of their unique requirements in order to establish acceptance criteria and guarantee product conformity, including collaboration on product and process validation, FAIR, and PPAP activities when needed.

Rotary die cutting machinery within ISO Class 8 clean room manufacturing space

ISO 9001:2015 Certification

PLITEK’s Quality Management System is certified to ISO 9001:2015, demonstrating our commitment to consistent quality, customer satisfaction, and continuous improvement. The certification covers the design and manufacture of films, coated and converted materials, adhesive-coated components, machined components, and application systems.


ISO 13485:2016 Certification

PLITEK is ISO 13485:2016 certified, demonstrating its commitment to maintaining a comprehensive quality management system for medical device manufacturing. The certification covers the contract manufacturing of films, coated web products, and converted film, foam, and foil components for the medical industry. Issued by DQS and recognized by IQNET, the certification is valid through June 6, 2028.

Clean room manufacturing workers in a controlled/clean manufacturing environment wearing protective garments and reviewing a tablet for quality assurance