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Norm
ÖVE/ÖNORM EN ISO 13485
Issue date: 2017 08 01
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016) (consolidated version)
This International Standard specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and r...
Withdrawn: 2022 02 01
§ Legal References
Publisher:
Austrian Standards International
Format:
Digital | 78 Pages
Language:
German
| English
Currently valid:
Optionally co-design standards:
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 organization’s 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.
If any requirement in Clauses 6, 7 or 8 of this International Standard is not applicable due to the activities undertaken by the organization or the nature of the medical device for which the quality management system is applied, the organization does not need to include such a requirement in its quality management system. For any clause that is determined to be not applicable, the organization records the justification as described in 4.2.2.
ÖVE/ÖNORM EN ISO 13485
2022 02 01
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)...
Norm
ÖVE/ÖNORM EN ISO 13485
2017 08 01
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)...
Norm
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ÖVE/ÖNORM EN ISO 13485
2016 07 01
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)...
Norm
ÖNORM EN ISO 13485
2012 11 01
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003 ...
Norm
ÖNORM EN ISO 13485
2010 02 15
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003 ...
Norm
ÖNORM EN ISO 13485
2007 11 01
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003)...
Norm
ÖNORM EN ISO 13485
2003 11 01
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003)...
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ÖVE/ÖNORM EN ISO 13488
2001 04 01
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ÖVE/ÖNORM EN ISO 13485
2001 04 01
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ÖVE/ÖNORM EN 46003
2000 02 01
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ÖNORM EN 46002
1996 12 01
Quality systems - Medical devices - Particular requirements for the application of EN ISO 9002
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ÖNORM EN 46002
1996 12 01
Quality systems - Medical devices - Particular requirements for the application of EN ISO 9002
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ÖNORM EN 46001
1996 12 01
Quality systems - Medical devices - Particular requirements for the application of EN ISO 9001
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ÖNORM EN 46001
1996 12 01
Quality systems - Medical devices - Particular requirements for the application of EN ISO 9001
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ÖNORM EN 46001
1994 02 01
Quality systems - Medical devices - Particular requirements for the application of EN 29001
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ÖNORM EN 46002
1994 02 01
Quality systems - Medical devices - Particular requirements for the application of EN 29002
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ÖNORM EN 46002
1994 02 01
Quality systems - Medical devices - Particular requirements for the application of EN 29002
Norm
ÖNORM EN 46001
1994 02 01
Quality systems - Medical devices - Particular requirements for the application of EN 29001
Norm
Norm
Issue date :
2022 02 01
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)