5.3.15 Reports on UEs to the management

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

Attachments