SS-EN-ISO-13485 › Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
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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. The processes required by this International Standard that are applicable to the organization, but are not performed by the organization, are the responsibility of the organization and are accounted for in the organizations quality management system by monitoring, maintaining, and controlling the processes.
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03.100.70 (Management systems Standards included in this sub-group shall also be included in other groups and/or sub-groups according to their subject Including environmental management systems (EMS), road traffic management systems, energy management systems, health care management systems, etc.)
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SS-EN ISO 13485:2016/AC:2018
2016/AC:2018 EDITION CORRIGENDUM
April 5, 2018
EN ISO 13485:2016/AC:2018(IDT); ISO 13485:2016(IDT)