ISO 13485:2016 Medical devices-Quality management systems-Requirements for regulatory purposes

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ISO 13485:2016(E) Medical devices-Quality management systems — Requirements for regulatory purposes1ScopeThis 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 applicab

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