ISO
13485:2003
ISO
13485 is the Quality Management System for Medical Device Manufacturers.
Released in the year 2003, it has become a regulatory requirement
for medical device manufacturers in most countries across the
globe.
The standard, ISO 13485:2003, was developed
by International Orgnization for Standardization on the basis
of it's popular quality management system standard, ISO 9001:2000.
As opposed to ISO 9001, it contains more specific requirements
for medical devices manufacturers to demonstrate their abilility
to 'maintain' (and not 'improve') the quality management system.
Who can apply:
- Manufacturers of medical devices
- Consultants which design, manufacture, and assemble medical
and in vitro diagnostic medical devices.
- Medical component manufacturers.
- Manufacturers of In Vitro Diagnostic Medical Devices that
want to distinguish themselves, and prepare for future IVD regulatory
obligations to enter the Europian Union.
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