scope:

This standard provides guidance on the establishment and maintenance of the Quality Systems defined in EN 29001/EN 46001 or EN 29002/EN 46002 for the manufacture of non-active medical devices. It does not add to, or otherwise change the requirements of those standards and it is not intended to be used for the assessment of a manufacturer's quality system. This standard provides examples of how to meet the requirements, recognising that other methods which achieve the same ends are equally acceptable; gives general advice on how to meet the requirements that may not be readily apparent to those unfamiliar with quality systems for medical devices.