ISO 13485
OCT 7, 2019

Gintzler International is Re-certified to ISO 13485:2016

ISO 13485 is an international quality standard that provides a foundation for a workable quality management system. 

Gintzler International–NY, a Resource Label Group Co., was recently re-certified to ISO 13485:2016, demonstrating our commitment to quality and attention to detail.  The surveillance audit was organized around our procedures, operations, documentation, performance and training. 

Why is ISO 13485 and Gintzler International important? 

  • Currently very few packaging printers can claim this honorable distinction, as this certification aligns our management system to the mandates of the FDA’s Quality System Regulation (QSR) requirements. 
  • 13485 dictates that risk management must be thoroughly documented and conducted throughout a product’s entire life-cycle, from initial concept to delivery and post-delivery. 
  • Gintzler maintains these demanding standards to help customers achieve their corporate packaging goals related to brand protection and to thwart counterfeiting. 
  • This distinction demonstrates our commitment to quality and customers, as well as our willingness to work towards improving efficiencies. 
  • This certification serves as a proven credential, as it is an independent verification against recognized standards. 
  • Gintzler’s Quality Management System closes the gap on regulatory changes and consumer protection. 

Benefits: 

  • Promotes consistency in production and traceability of products due to more effective risk management and documentation. 
  • Includes security controls best suited for the needs of the individual customer. 
  • Improves the ability to respond to customer requirements – clients have more reason to trust and purchase products of consistent high quality. 
  • Supports full chain-of-custody initiatives by operating within a secure production facility. 
  • Lowers production costs due to fewer nonconforming products, less rework, lowered rejection rates, and streamlined processes. 

With re-certification, Gintzler continues on its path to deliver customized label and package identification solutions to the medical and pharmaceutical markets. 

Visit www.gintzlerpharm.com or contact us at pharma@gintzler.com to learn more.

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