BS EN ISO 13485:2012,Medical devices – Quality management systems – Requirements for regulatory purposes (ISO 13485:2003 )
Main Keywords of BS EN ISO 13485:2012 :Quality assurance systems;Medical instruments;Medical technology;Medical equipment;Quality management;
This British Standard is the UK implementation of EN ISO 13485: 2012.It is identical to ISO 13485: 2003, incorporating corrigendum August 2009. It supersedes BS EN SO 13485: 2003, which will be
withdrawn on 31 August 2012.
The requirements in ISO 13485: 2003 describe a systematic approach, within which manufacturers can identify, review and decide on the appropriate manner to incorporate regulatory requirements, other standards, and regulatory guidance documents into their quality management system.
BS EN ISO 13485:2012 specifies requirements for a quality management system that can be used by an organization for the design and development production, installation and servicing of medical devices, and the design, development, and provision of related services.
It can also be used by intemal and extemal parties, including certification bodies, to assess the organization’s ability to meet customer and regulatory requirements.
BS EN ISO 13485:2012 download
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