10.10.18
Gintzler International – NY, a Resource Label Group company, has successfully upgraded its 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,” says Dan Rozanski, general manager of Gintzler International – NY.
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:
“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,” says Dan Rozanski, general manager of Gintzler International – NY.
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; and
- Definition of the required competence of personnel involved in quality management documentation and verification of the effectiveness of training measures.