This European Standard provides guidance on the establishment and maintenance of the quality systems specified in EN 29001/EN 46001 or EN 29002/EN 46002 for the manufacturer of non-active medical devices. It does not add to, or otherwise change, the requirements of those standards and is not intended to be used for the assessment of a manufacturer's quality system.

This European Standard provides examples of how to meet the requirements, recognizing that other methods which achieve the same ends are equally acceptable; gives general advice on how to meet the requirements; and draws attention to aspects of requirements that may not be readily apparent to those unfamiliar with quality systems for non-active medical devices.

Annex A to this European Standard provides guidance on the elements of quality systems which are relevant to the manufacture of medical devices which are to be supplied either sterile or at a defined level of microbiological or particulate cleanliness.

The adoption of systems other than those described in this European Standard is not to be regarded as a non-compliance with EN 29001 and EN 29002 and/or the specific requirements in EN 46001 and EN 46002.