ISO 13485 is the quality management system standard for organizations engaged in medical device manufacturing.
ISO 13485 is based on ISO 9001 and supplemented with additional quality management requirements relating to design, special processes, environmental control, traceability, documentation, and regulatory actions. Unlike ISO 9001, which requires organizations to demonstrate continual improvement, ISO 13485 requires only that an organization demonstrate that the quality system for medical device manufacturing is implemented and maintained.
Although being registered does not fulfill the requirements of the various industry regulators, such as those of the U.S. Food and Drug Administration (FDA), ISO 13485 is commonly used as the basis for regulatory requirements. As such, the ISO 13485 standard is an essential consideration not only for exporters but also for the local market, global suppliers, and subcontractors to prove that their medical device products are of the highest quality.
Benefits of ISO 13485 Registration
Organizations that are registered to the ISO 13485 standard are recognized for delivering medical devices and related services that consistently meet customer and applicable regulatory requirements. In addition, certification to the ISO 13485 standard is often a prerequisite if you want to sell your product outside of the United States.
Why Oriel STAT A MATRIX?
By choosing Oriel STAT A MATRIX, you benefit from our experience as a worldwide consultant in quality management and business process improvement. We do not simply conduct ISO 13485 training and consulting but show you how to use the complete ISO 9000 series as an integral tool to improve your efficiency, productivity, and profitability.
Our flexible ISO 13485 training and consulting services can help you:
- Develop a new ISO 13485 quality management system
- Integrate ISO 13485 with an existing U.S. FDA Good Manufacturing Practice quality system
- Upgrade from ISO 9001 to ISO 13485
Learn more about ISO 13485 training and consulting