BS EN ISO 13485

• Quality management
• Environmental management
• Health and safety
• Integrated management
• Process improvement
• Contact the MCR
• Customer feedback
• Become a registered consultant

Medical devices - Quality management systems - Requirements for regulatory purposes

EN ISO 13485:2003 is the current European medical device quality system standard, published July 24, 2003. The three year transition period for implementing this standard finished in July 2006

This international standard specifies requirements for a quality management system where an organisation 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 this standard is to facilitate harmonised medical device regulatory requirements for quality management systems. It includes some particular requirements for medical devices and excludes some of the requirements of ISO 9001 that are not appropriate as regulatory requirements.

Organisations that comply with ISO 13485, cannot claim conformity to ISO 9001, unless their system complies fully with the requirements of ISO 9001.