The ISO 13485 -what is it?

The ISO 13485 

For anyone in the medical devices industry; the real buzzword perhaps is ISO 13485:2003. What is it? How does it matter to the industry? What are its exceptions?

The medical device industry, given its enormous impact on human health and welfare; is highly regulated all over the world. In the leading blocks, namely the US, EU and Canada; it is regulated by the FDA, European Medical Devices Directives and the Canadian Medical Device Bureau respectively. In addition, ministries of health regulate this industry around the world.

What is it?

ISO 13485:2003 sets out the quality system standards for this industry. This standard sets out “…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.”(

What is the aim of ISO 13485:2003?

The main aim of ISO 13485:2003 is to foster harmonized regulatory requirements for quality management systems in medical device. Thus, it is mandatory for all medical device organizations to conform to what is set out in ISO 13485:2003, no matter what size or type it is.


Only those design and development controls that are permitted to be excluded from regulatory requirements can be excluded the quality management system. When such exclusions are allowed; alternative implementations set out by these regulations have to be applied. The organizations that make these alternative arrangements have the responsibility of ensuring that claims of conformity with this standard reflect exclusion of design and development controls.

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