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This document specifies the requirements for implementation of a quality system along the patient pathway in Radiology services. The objective is to ensure high quality delivery of all aspects of the examination safety and patient care.
This document deals with procedures using X-rays, ultrasonography and magnetic resonance imaging on humans, including diagnostic procedures and interventional Radiology as well as remote practices. It also applies, in its principles, to any other technique and modality that would be used in Radiology services.
The document covers:
- the different steps of patient care (from the imaging referral, before, during, and after the examination);
- the corresponding human resources and technical-medical requirements;
- quality and risk management.
This document does not apply to radiotherapy and nuclear medicine, nor to equipment and radiation controls which are covered in other standards. This document excludes requirements related to research and education themes.
This document establishes best practices description which constitutes a reference for audits, including clinical audits. Nevertheless, the clinical audits methodology, already defined at the European level, and implemented under the responsibility of each country is excluded from the document.