Requirements for Servicing of Medical Imaging Equipment

Abstract

This Standard describes and defines the minimum quality management system requirements for servicing of medical imaging equipment to ensure a return to a safe and effective condition for its intended use.

Requirements determined by Authorities Having Jurisdiction (AHJ) take precedence in the event they conflict with this Standard.

The requirements of this Standard are intended to be applicable to any medical imaging equipment servicing organization, regardless of size, or the specific equipment maintenance services it provides.

The provider of applicable services may be an individual organization or may be an operating unit within an organization.

This quality management system Standard does not address operations other than medical imaging equipment servicing.

Organizations providing products or services in addition to medical imaging equipment servicing may also need to comply with additional requirements that are associated with their other products or services.

Similarly, compliance with other quality management system Standards does not necessarily constitute compliance with this Standard.