Certified to ISO 13485:2016 Standard
ISO 13485 is an international quality standard that provides a foundation for a workable quality management system:
- This certification aligns our management system to the requirements of the FDA’s Quality System Regulation (QSR) requirements as well as many other regulatory requirements found throughout the world.
- 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.
- Our certification serves as a proven credential, as it is an independent verification against recognized standards.
- Our management system closes the gap on regulatory changes—GS1, FDA and consumer protection.
