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8.5.1 General :
General :
Version:
1.0
Project :
Author:
Wolfgang Kern
Created:
07.03.2014
Modified:
13.09.2017 23:47:27
Diagram Elements :
Medical Device Reporting (MDR) to NCAs
Complaint report
Solve complaint verbally
Provide Hotline and SERVICE LEVEL 0
Evaluate business process performance
Manage business process complaints
8.5 Improvement : 8.5 Improvement
8.5.1 Establish procedures to notify requlatory authorities about adverse events
8.5.1 Authorize and record reason if any customer compaint is not followed by CAPA
8.5.1 Records of customer complaint investigations
8.5.1 Procedures for the issue and implementation of advisory notices
8.5.1 Identify and implement any changes necessary to ensure and maintain theeffectiveness of the QMS
