ISO 13485: 2003 represents the requirements that medical device manufacturers must incorporate into their management systems. ISO 13485:2003 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 requirements and regulatory requirements applicable to medical devices and related services.
The primary objective of ISO 13485 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 ISO 9001 that are not appropriate as regulatory requirements. Because of these exclusions, organizations whose quality management systems conform to this International Standard cannot claim conformity to ISO 9001 unless their quality management systems conform to all the requirements of ISO 9001.
All requirements of ISO 13485 are specific to organizations providing medical devices, regardless of the type or size of the organization. 13485 dictates that risk management must be thoroughly documented and conducted throughout a product's entire lifecycle, from initial concept to delivery and post-delivery.
Whatever devices you produce, as a medical device manufacturer you have a responsibility to consistently deliver devices that are safe and effective. ISO 13485:2003 is the international standard recognized for medical device regulations around the world.
ISO 13485: 2003 has been harmonized against the three Directives (Medical Devices, In-vitro Diagnostic Devices and Active Implantable Devices) so certification to this standard by an international certification body such as SMC automatically demonstrates compliance with specific clauses in the regulations.