SS-EN-ISO-13485 › Medical devices - Quality management systems - Requirements for regulatory purposes - Technical Corrigendum 1 (ISO 13485/Cor 1:2009 )
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2016 EDITION CORRIGENDUM 1 - Jan. 18, 2017
2018 EDITION - April 5, 2018
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.
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Active implantable medical devices. Medical devices. In vitro diagnostic medical devices. Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market
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SS-EN ISO 13485:2012/AC:2012
2012 EDITION CORRIGENDUM 1
Oct. 16, 2012
EN ISO 13485:2012/AC:2012(IDT); ISO 13485/Cor 1:2009(IDT)