SR EN ISO 13485:2012

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003)

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

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General information

Status : Withdrawn
Approval date : 7/31/2012
Withdrawal date : 3/31/2019
Number of pages : 87
ICS : 03.100.70 Management systems,11.040.01 Medical equipmet in general
Technical Committee : 377 - Medical devices

Relations with other standards: