ISO 13485 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 ISO 13485 is to facilitate harmonised 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. The two notable exclusions are; proactive monitoring of customer satisfaction and the requirement to demonstrate continual improvement of the quality management system. Because of these exclusions, organisations whose quality management systems conform to ISO 13485 cannot claim conformity to ISO 9001 unless their quality management system conforms to all the requirements of ISO 9001.