The ISO 13485 standard is an effective solution to meet the comprehensive requirements for a QMS. Adopting ISO 13485 provides a practical foundation for manufacturers to address the medical device directives, regulations and responsibilities as well as demonstrating a commitment to the safety and quality of medical devices.
ISO 13485 certificates are known and trusted in the medical device industry by authorities, suppliers and manufacturers around the world.
ISO 13485 is a stand-alone QMS standard, derived from the internationally recognized and accepted ISO 9000 quality management standard series. ISO 13485 adapts the ISO 9000 process-based model for a regulated medical device manufacturing environment. While ISO 13485 is based on the ISO 9001 process model concepts of Plan, Do, Check, Act, it is designed for regulatory compliance. It is more prescriptive in nature and requires a more thoroughly documented quality management system.
ISO 13485 was written to support medical device manufacturers in designing quality management systems that establish and maintain the effectiveness of their processes. It ensures the consistent design, development, production, installation, and delivery of medical devices that are safe for their intended purpose.
Benefits of ISO 13485 Certification
- Increase access to more markets worldwide with certification
- Outline how to review and improve processes across your organization
- Increase efficiency, cut costs and monitor supply chain performance
- Demonstrate that you produce safer and more effective medical devices
- Meet regulatory requirements and customer expectations