5.3.15 Reports on UEs to the management Estimated reading: 1 minute 131 views Authors Purpose and goal Clear presentation of reports on adverse events, incidents involving medical devices, (occupational) accidents, special incidents, results of the evaluation of reporting registers, results of hazard analyses, alerts, complaints and claims. The report should be submitted to the management during the annual management review. When setting quality targets, a certain number of e.g. 10 safety targets for the following period and corresponding preventive measures are derived after weighting (see 5.4.03). DIN EN ISO 9001:2015 and DIN EN 15224:2017 8.7.2; QM-RL:2015 § 4 (1) - -error management systems, sentence 7 Area of application Annual reports from the QM coordinator to the management Description of the to the process instruction here Download Attachments 5.3 Dealing with risks and opportunities - Previous 5.3.14 Evaluation of external reports on AEs and errors Next - 5.3 Dealing with risks and opportunities 5.3.16 Duty to inform in the event of adverse events
