WILLIAMSVILLE, NY—Gintzler International – New York, a resource label group company, has successfully upgraded their quality management system registration to ISO 13485:2016.
“ISO 13485 has continued to evolve in ways that enhance quality, risk analysis and the focus on listening to our customers. We have upgraded our procedures to match the new requirements and successfully completed our audit to the new standard,” said Dan Rozanski, general manager of Gintzler International – New York.
One of the important changes of the revision is that the new ISO 13485 uses a risk management approach in all processes of the quality management system.
Other major changes include:
- Validation of the computer software used in the quality management system
- New requirements for complaint-handling processes
- Definition of the required competence of personnel involved in quality management documentation and verification of the effectiveness of training measures
“Our recent upgrade of this widely recognized ISO quality standard represents the culmination of significant effort by our entire team,” adds Rozanski. “This latest company achievement is an essential part of the organization’s strategy and a testament to our ongoing commitment to provide label and package identification solutions to clients in the medical and pharmaceutical markets.”