Tagasi

ISO 13485:2003

Medical devices -- Quality management systems -- Requirements for regulatory purposes

Üldinfo
Kehtetu alates 24.02.2016
Direktiivid või määrused
puuduvad
Standardi ajalugu
Staatus
Kuupäev
Tüüp
Nimetus
25.02.2016
Põhitekst
Põhitekst
Põhitekst
ISO 13485:1996
ISO 13485:2003 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 requirements and regulatory requirements applicable to medical devices and related services. The primary objective of ISO 13485:2003 is to facilitate harmonized medical device regulatory requirements for quality management systems. As a result, it includes some particular requirements for medical devices and excludes some of the requirements of ISO 9001 that are not appropriate as regulatory requirements. Because of these exclusions, organizations whose quality management systems conform to this International Standard cannot claim conformity to ISO 9001 unless their quality management systems conform to all the requirements of ISO 9001. All requirements of ISO 13485:2003 are specific to organizations providing medical devices, regardless of the type or size of the organization. If 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 regulations can provide alternative arrangements that are to be addressed in the quality management system. It is the responsibility of the organization to ensure that claims of conformity with ISO 13485:2003 reflect exclusion of design and development controls. If any requirement(s) in Clause 7 of ISO 13485:2003 is(are) not applicable due to the nature of the medical device(s) for which the quality management system is applied, the organization does not need to include such a requirement(s) in its quality management system. The processes required by ISO 13485:2003, which are applicable to the medical device(s), but which are not performed by the organization, are the responsibility of the organization and are accounted for in the organization's quality management system.
*
*
*
PDF
64,44 € koos KM-ga
Paber
64,44 € koos KM-ga
Standardi monitooring
Teised on ostnud veel
Põhitekst

EVS-EN ISO 14971:2012

Meditsiiniseadmed. Riskijuhtimise rakendamine meditsiiniseadmetele
Kehtetu alates 02.01.2020
Põhitekst

ISO 14001:2004

Environmental management systems -- Requirements with guidance for use
Kehtetu alates 14.09.2015
Põhitekst + parandus

EVS-EN ISO 9001:2008

Kvaliteedijuhtimissüsteemid. Nõuded
Kehtetu alates 06.10.2015
Põhitekst

ISO/TR 14969:2004

Medical devices -- Quality management systems -- Guidance on the application of ISO 13485: 2003
Uusim versioon Kehtetu alates 24.02.2016