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Medical devices -- Quality management systems

This standard is published in 2003, Later on it is upgraded to 2016. This standard represents the requirements of a comprehensive management system for the design and manufacture of medical devices. Standard supersedes earlier documents such as EN 46001 and EN 46002 (both 1997), the ISO 13485 published in 1996 and ISO 13488 (also 1996).

The primary objective of this standard is to facilitate harmonised medical device regulatory requirements for quality management systems. ISO 13485 is a standalone standard. It is largely based on the structure of ISO 9001, but includes some particular requirements for medical devices such as risk analysis, sterile manufacturing and traceability.

ISO 13485