5.4.03 Corrective and preventive measures Estimated reading: 1 minute 138 views Authors Goal and purpose Corrective and preventive measures are based on an analysis of "undesirable events", on the reports of internal audits, on customer complaints, results of quality control and the evaluation of external experience (literature, individual case reports, e.g. from cases of damage). It must be regulated how the information is passed on, who orders corrective and preventive measures and how their implementation is monitored. DIN EN ISO 9001:2015 and DIN EN 15224:2017 10.2.1 a), c) - g) Area of application Description of the Documentation The processing of corrective actions must be documented. A list must be drawn up containing: a) the type of non-conformity b) the corresponding corrective action c) the result of the corrective action In the case of non-conformities affecting a patient, the corrective action must also be documented in the patient file Resources Responsibility and qualification Notes and comments Applicable documents Literature Terms Attachments Annual list of non-conformities and corrective actionsDownload 5.4 Improvement measures - Previous 5.4.02 Risk analysis (Failure mode and effects analysis) Next - 5.4 Improvement measures 5.4.04 Individual case analysis of a UE
