Regulatory Affairs Certification (RAC) Practice Exam

Which of the following is NOT part of the Quality System Regulation for manufacturers of finished devices?

1. Quality audits by external personnel

2. Annual audits of operations

3. Documenting quality audit results

4. Management review of findings

The correct answer is: Annual audits of operations

The practice of conducting annual audits of operations is not explicitly mandated within the Quality System Regulations (QSR) for manufacturers of finished medical devices. While regular audits are essential to ensure compliance and continuous improvement, the QSR emphasizes the need for quality audits, documentation of those audits, and management reviews to foster a strong quality management system. The other options highlight requirements that are indeed part of the QSR. For instance, quality audits by external personnel can be vital to provide an unbiased assessment of compliance with the regulatory standards. Documenting the results of quality audits ensures that there is a formal record of findings and actions taken. Similarly, management review of the audit findings is crucial as it allows for high-level oversight and decision-making regarding the quality management system. These practices all contribute to a comprehensive framework aimed at maintaining standards and ensuring the safety and effectiveness of medical devices.