ISO 13485 is a quality management standard for medical devices. It defines a set of quality management requirements. The purpose of this standard is to help both medical devices suppliers and service providers to meet customer expectations and requirements. ISO 13485 applies to medical device suppliers and medical device service providers of all kinds. It applies to organizations that participate in one or more stages of the product life cycle. Also that design, develop, produce, store, distribute, install, or service medical devices and to organizations that design, develop, or provide related medical device support service activities.