DS/EN ISO 13485:2012
Medical devices - Quality management systems - Requirements for regulatory purposes

Standard No.

DS/EN ISO 13485:2012

Release Date

2012

Published By

Danish Standards Foundation

Status

Be replaced 2012-08

Replace By

DS/EN ISO 13485/AC:2012

Latest

DS/EN ISO 13485:2021

Replace

DS/EN ISO 13485:2003 DS/EN ISO 13485/AC:2007 DS/EN ISO 13485/AC:2009

Scope

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 qu

DS/EN ISO 13485:2012 history

• 2021 DS/EN ISO 13485:2021 Medical devices – Quality management systems – Requirements for regulatory purposes (ISO 13485:2016)
• 2012 DS/EN ISO 13485/AC:2012 Medical devices - Quality management systems - Requirements for regulatory purposes - Technical Corrigendum 1
• 2012 DS/EN ISO 13485:2012 Medical devices - Quality management systems - Requirements for regulatory purposes
• 0000 DS/EN ISO 13485/AC:2009
• 0000 DS/EN ISO 13485/AC:2007
• 0000 DS/EN ISO 13485:2003