Internal audits shall be carried out on a planned cycle so the laboratory knows whether its management system meets its own requirements (laboratory activities included) and the requirements of this document, and whether the system is working in practice and being kept up. The laboratory shall plan, set up, run and maintain an audit programme that puts patient risk first and provides for: a schedule that takes account of identified risks, results of external evaluations and earlier audits, nonconformities, incidents, complaints and changes; audit-by-audit definition of objectives, criteria and scope; auditors with the training, qualifications and authorization for the job and, where resources allow, independent of the work audited; an objective and impartial audit process; reporting of findings to the personnel concerned; correction and corrective action taken promptly; and records kept. ISO 19011 offers guidance.
The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.