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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. This standard will replace current harmonized standards such as EN ISO 13485:2000 and EN ISO 13488:2000 with a three year transition period ending July 2006.
This international standard 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 and regulatory requirements applicable to medical devices and related services.
The primary objective of this standard is to facilitate harmonized 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.
Organizations that comply with ISO 13485 cannot claim conformity to ISO 9001, unless their system complies fully with the requirements of ISO 9001.
Similar Standards
JIS Q 13485
JIS Q 13488
This is only an overview/extract of the standard. Users should not rely on its accuracy, but should refer to the complete standard of the appropriate revision.