The ISO 9001 quality management systems standard is based on a number of quality management principles including a strong customer focus, the motivation and implication of top management, the process approach and continual improvement. Using ISO 9001 helps ensure that customers get consistent, good quality products and services, which in turn brings many business benefits.
ISO 13485 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 and applicable regulatory requirements. Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support).
ISO 14001 standard specifies the requirements for an environmental management system that an organization can use to enhance its environmental performance. The standard is intended for use by an organization seeking to manage its environmental responsibilities in a systematic manner that contributes to the environmental pillar of sustainability. ISO 14001 helps an organization achieve the intended outcomes of its environmental management system, which provide value for the environment, the organization itself and interested parties.