ISO 13485:2016(E) Medical devices-Quality management systems — Requirements for regulatory purposes

ISO 13485:2016(E) Medical devices-Quality management systems — Requirements for regulatory purposes 1Scope This International Standard specifies requirements for a quality management system where anorganization needs to demonstrate its ability to provide medical devices and related services thatconsistently meet customer and applicable regulatory requirements.Such organizations can be involvedin one or more stages of the life-cycle, including design and development, production, storage anddistribution, installation, or servicing of a medical device and design and development or provision ofassociated activities (e.g. technical support). This International Standard can also be used by suppliersor external parties that provide product, including quality management system-related services to suchorganizations. Requirements of this International Standard are applicable to organizations regardless of their sizeand regardless of their type except where explicitly stated. Wherever requirements are specified asapplying to medical devices, the requirements apply equally to associated services as supplied by theorganization. The processes required by this International Standard that are applicable to the organization, butare not performed by the organization, are the responsibility of the organization and are accountedfor in the organization's quality management system by monitoring,maintaining, and controlling theprocesses. lf applicable regulatory requirements permit exclusions of design and development controls, this canbe used as a justification for their exclusion from the quality management system. These regulatoryrequirements can provide alternative approaches that are to be addressed in the quality managementsystem. lt is the responsibility of the organization to ensure that claims of conformity to thisInternational Standard reflect any exclusion of design and development controls. lf any requirement in Clauses 6, Z or 8 of this International Standard is not applicable due to theactivities undertaken by the organization or the nature of the medical device for which the qualitymanagement system is applied, the organization does not need to include such a requirement in itsquality management system.For any clause that is determined to be not applicable, the organizationrecords the justification as described in 4.2.2.