The international standard ISO 13485 Medical devices - Quality management systems - Requirements for regulatory purposes specifies the requirements for the quality management system, when the organization needs to demonstrate its ability to provide medical devices and related services that consistently meet user requirements and applicable regulations. Such organizations may be involved in one or more phases of the life cycle, including the design and development, production, storage and distribution, installation or servicing of a medical device, as well as the design and development or provision of related activities (eg technical support). This International Standard may also be used by suppliers or external parties providing the product, including the quality management system services they provide to such organizations.
By implementation and certification according to ISO 13485:
- commitment to the quality of medical devices is proven;
- overall performance of the process is improved;
- improved communication with the market and the possibility of access to new customers and markets;
- efficiency increases and costs decrease;
- it is proven that safer and more efficient medical devices are produced;
- knowledge of legal requirements and customer expectations is proven;
- profit increases;
- competitiveness increases;
- customer satisfaction increases;
- internal relations improve;
- international verification of good business practice is obtained;
- framework for continuous process improvement is created.