An outline to show the structure of the quality system should be created. Besides being required under the regulation and the standards, internal quality audits are vital to the on-going health of the system. It is vital that management support the auditing function and work to keep it as a tool for continuous improvement. Quality audits must be conducted by individuals who do not have direct responsibility for the areas being audited. They are used to assure compliance with established quality system requirements.
Audits assess whether the existing quality system is effective.
Audit findings which continually repeat will indicate a systemic problem which management must address. For such occasions, corrective actions are indicated, with reaudits of deficient areas to assess whether corrective actions were effective. Companies must maintain sufficient personnel who possess the education, background, training, and experience to assure proper performance of their duties. Training procedures must be established which include assessment of training necessary so that all personnel can adequately perform their responsibilities. The Quality System Regulation requires that the training plan include methods by which personnel receive information about the defects that may occur to devices on which they work if they do not perform their job functions properly.