ISO 13485:2003 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements, regulatory requirements applicable to medical devices and related services. ISO 13485 is the internationally recognized standard for quality management systems in the medical device industry. It is designed and intended for use by organizations for the design and development, production, installation, servicing and sales of medical devices. It specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices, and that related services consistently meet customer requirements and applicable regulatory requirements. How can ISO 13485 helps to: 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.
Customer satisfaction – through delivery of products that consistently meet customer requirements as well as quality, safety and legal requirements.
Reduced operating costs – through continual improvement of processes and resulting operational efficiencies.
Improved stakeholder relationships – including staff, customers and suppliers.
Improved risk management – through greater consistency and traceability of products and use of risk management techniques.
Legal compliance – by understanding how statutory and regulatory requirements impact the organization and its customers.
Proven business credentials – through independent verification against recognized standards.
Ability to win more business – particularly where procurement specifications require certification as a condition to supply in a highly regulated sector.