SIS-EN-ISO-13485 › Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
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Included in this current edition are the following subparts:
EDITION 4 - March 7, 2016
2016/AC:2017 EDITION CORRIGENDUM - March 23, 2016
2016/AC:2018 EDITION CORRIGENDUM - Jan. 18, 2018
2016/A11 2021 EDITION - Sept. 13, 2021
2016/AC:2017 EDITION CORRIGENDUM - March 23, 2016
2016/AC:2018 EDITION CORRIGENDUM - Jan. 18, 2018
2016/A11 2021 EDITION - Sept. 13, 2021
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. If applicable regulatory requirements permit exclusions of design and development controls, this can be used as a justification for their exclusion from the quality management system. These regulatory requirements can provide alternative approaches that are to be addressed in the quality management system. It is the responsibility of the organization to ensure that claims of conformity to this International Standard reflect any exclusion of design and development controls.
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Active implantable medical devices. Medical devices. In vitro diagnostic medical devices
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Designation Name
SS-EN ISO 13485:2016
Revision Level
EDITION 4
Status
Current
Publication Date
March 7, 2016
Language(s)
English
Page Count
76
International Equivalent
EN ISO 13485:2016(IDT); ISO 13485:2016(IDT)