BS EN ISO
13485:2003
Medical devices -
Quality management systems - Requirements for regulatory purposes
This Standard
is aimed at companies that design, develop, produce, install or
service medical devices and 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.
The newly
published BS EN IS013485: 2003 Medical Devices. Quality Management
Systems. Requirements for Regulatory Purposes now includes a
requirement for senior management "buy-in" as specified in ISO
9001:2000. However the primary objective 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 BS EN ISO 9001 that are not appropriate as
regulatory requirements. Therefore, while BS EN ISO 13485:2003 has
the same format as BS EN ISO 9001:2000 and most of the same
requirements, compliance with BS EN ISO 13485:2003 does not
provide conformity with BS EN ISO 9001:2000.
One of the
major differences is that BS EN IS013485: 2003 has a greater
requirement for documented procedures than ISO 9001:2000
BS EN ISO
13485:2003 supersedes BS EN ISO 13485:2001 and BS EN 1S0
13488:2001 which will be withdrawn in July 2006. To maintain their
certified status all organizations within the medical devices
industry must adopt BS EN 13485:2003
