ISO 13485:2003
Medical and In-Vitro Diagnostic Medical Devices
ISO 13485:2003 specifies requirements for a Quality Management System(QMS) 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. Any organisation working in the Medical or In-Vitro Dagnostic Medical Device Sectors as the primary objective of ISO 13485:2003 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 9001:2000 such as customer satisfaction and continual improvement. ISO 13485:2003 has not been adopted by the FDA who participated in writing the Standard to make sure their requirements were aligned. If an organisation needs to meet the requirements of ISO 13485:2003, they should easily be able to meet FDA requirements. WHAT IS ISO 13485:2003
What Organisations Should have it
How Is It Different from ISO 9001:2000
Unlike ISO 9001:2000 it has not been written as a business improvement model - but as a tool for maintaining the effectiveness of processes.
Organisations whose quality management systems conform to ISO 13485:2003 cannot claim conformity to ISO 9001:2000 unless their quality management systems conform to all the requirements of ISO 9001:2000.
All requirements of ISO 13485:2003 are specific to organisations providing medical devices, regardless of the type or size of the organisation. It is a more prescriptive standard requiring more procedures to be documented.
Quality System Regulations
