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(b)<br />

(c)<br />

(d)<br />

Ensuring that appropriate equipment is available;<br />

Ensuring that appropriate reference material is available;<br />

Supporting necessary corrective actions.<br />

5.1.1.4. Documentation<br />

Quality assurance policies and procedures for all imaging modalities and<br />

auxiliary equipment, as well as radiation protection policies and procedures,<br />

should be documented in quality manuals and be readily accessible to staff at all<br />

times. Equipment documentation should be complete (see Section 3.1.5).<br />

The following specific documentation is required:<br />

(a)<br />

(b)<br />

General:<br />

(i) Equipment and room condition documentation;<br />

(ii) An operator’s manual and user charts/guides;<br />

(iii) Training manuals for personnel to use equipment;<br />

(iv) Imaging protocols, including those for procedure optimization, and<br />

typical patient dose data (see Sections 4.1.3.2 and 4.1.3.4).<br />

Quality assurance:<br />

(i) Acceptance testing guides;<br />

(ii) Quality control protocols and schedules;<br />

(iii) Image quality evaluation guide, repeat/reject analysis protocol and<br />

records of results;<br />

(iv) Equipment maintenance manuals;<br />

(v) Equipment disposal documentation.<br />

(c) Radiation protection and safety (see Section 5.1.2):<br />

(i) Results with details of conduct and frequency of radiation protection<br />

surveys and shielding checks;<br />

(ii) Records of patient radiation protection measures taken (see also<br />

Sections 5.1.3–5.1.5);<br />

(iii) Inventory of available radiation protection devices (e.g. lead aprons<br />

and portable shields);<br />

(iv) Room access control, warning signs and signals documentation.<br />

(d)<br />

(e)<br />

Dosimetry:<br />

(i) Inventory of dosimetry equipment and calibration documentation;<br />

(ii) Calibration methodology manual;<br />

(iii) Patient dose determinations and diagnostic reference levels (DRLs);<br />

Reports from regulatory inspections and voluntary audits.<br />

47

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