Commentaries: Art. 43

All holders of licences for radiation applications as specified in Article 41 paragraph 3 shall conduct an annual self-evaluation of their processes.
They shall prepare a quality manual and present this at the audit.
The quality manual must include a detailed description of at least the following points:
1. competences and responsibilities;
2. equipment available for examination and treatment;
3. personnel training;
4. measures to ensure compliance with requirements concerning the justification of individual applications (Art. 29);
5. examination and treatment protocols and patient information;
6. documentation of radiation doses (Art. 33);
7. establishment and communication of diagnostic findings or treatment monitoring, data storage and data transfer;
8. quality assurance;
9. self-evaluation.