Quality Management System For The Design And Manufacture Of Medical Devices

ISO 13485 certification, an international standard that defines quality management handsystem (QMS) requirements for manufacturers of medical devices. The primary objective of the standard is to facilitate harmonised QMS requirements for regulatory purposes within the medical device sector.

It is applicable to manufacturers of medical devices and to those organisations that support medical device manufacturers. Manufacturers have a duty to ensure that devices consistently meet customer requirements and meet all applicable regulatory requirements.

Last revised in 2003, this standard is based on the ISO 9001 process model approach. However, it includes particular requirements for medical devices and excludes some of the requirements for ISO 9001. In particular, the requirements for customer satisfaction and continual improvement have been modified to make them more appropriate for regulatory purposes.

ISO 13485 certification promotes harmonisation of regulatory requirements for manufacturers of medical devices on an international scale.

A number of countries have incorporated ISO 13485 into their regulatory systems. Compliance with ISO 13485 can be used in support of regulatory compliance. It incorporates many of the quality management principles and delivers the benefits of an ISO 9001 based quality management system.