The International Organization for Standardization (ISO) defines Quality Assurance (QA) as all planned and systematic actions needed to provide confidence that a structure, system, or component will perform satisfactorily in service. In nuclear medicine, satisfactory performance means ensuring optimum quality throughout the entire process. Since a procedure is justified only when it benefits the patient, QA plays a crucial role in radiation protection.
An effective QA programme requires a strong commitment from the management of the nuclear medicine facility, ensuring the necessary resources such as time, personnel, and budget. It is recommended that a dedicated QA committee be established, comprising:
The QA committee should meet regularly to review various components of the programme.
The QA programme should cover the entire process, from the initial decision to adopt a particular procedure through to the interpretation and recording of results. It should include ongoing auditing, both internal and external, as part of a systematic control methodology. The maintenance of records is an essential part of QA.
A key component of the QA programme is continuous quality improvement, which implies a commitment by staff to continuously improve the use of unsealed sources in diagnosis and therapy. This process is based on new information learned from the QA programme and new techniques developed within the nuclear medicine community. Feedback from operational experience and lessons learned from accidents or near misses should also be systematically used to identify and correct potential problems.
The QA programme should cover all aspects of nuclear medicine, including:
The QA programme should be assessed regularly, either through internal or external audits or reviews. These audits should be scheduled based on the status and importance of the activity. Management should establish a process for conducting these assessments to identify and correct any administrative or management issues that might hinder the achievement of QA objectives.
Audits and reviews should be conducted by technically competent individuals who do not have direct responsibility for the activities being assessed. These auditors may be staff from other work areas (internal audit) or independent assessors from other organizations (external audit). External audits are typically required for accredited practices.
The quality audit should be conducted according to written procedures and checklists, encompassing medical, technical, and procedural checks. The goal is to enhance the effectiveness and efficiency of the QA programme. Any major changes to the QA programme should trigger an audit. The results of the audit should be documented, and necessary corrections should be implemented and followed up on.