ISO 13485 Accreditations

This International Standard specifies requirements for a quality management system that can be used by an organization involved in one or more stages of  the life-cycle of a medical device, including design and development, production, storage and distribution, installation, servicing and final decommissioning and disposal of medical devices, and design and development, or provision of associated activities (e.g. technical support). The requirements in this  International Standard can also be used by suppliers or other external parties providing product (e.g. raw materials, components, subassemblies, medical devices, sterilization services, calibration services, distribution services, maintenance services) to such organizations. The supplier or external party can voluntarily choose to conform to the requirements of this International Standard or can be required by contract to conform.

This International Standard 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). This International Standard can also be used by suppliers
or external parties that provide product, including quality management system-related services to such organizations.

Requirements of this International Standard are applicable to organizations regardless of their size and regardless of their type except where explicitly stated. Wherever requirements are specified as applying to medical devices, the requirements apply equally to associated services as supplied by the
organization.