A complaint in the healthcare sector refers to a customer or patient’s notification of dissatisfaction with a product or service. This can relate to a medical device, medicine, or healthcare service, for example. Complaints are crucial as they provide indications of possible defects or errors that could jeopardise patient safety or affect regulatory compliance.
Complaints are vital because they provide direct feedback on products or services and allow problems to be addressed early. By systematically recording and analysing complaints, companies can identify trends, make improvements, and strengthen customer confidence.
The scope of complaints covers all products and services offered by healthcare companies. It covers the entire product life cycle, from development and manufacture to use by the end consumer.
Complaints management
Establishing and maintaining a complaints management system in the healthcare sector involves several key steps:
- Define structure and responsibilities: Establish a clear process with defined roles and responsibilities for handling complaints.
- Process documentation: creation of standardised procedures for recording, evaluating, processing and tracking complaints.
- Training and awareness: training of employees in the relevant departments to ensure that complaints are correctly recognised and reported.
- System for recording and analysing: Implementation of an IT-supported system for systematically recording and analysing complaints in order to identify trends and derive improvements – FORM-Guard
- Regular review and adjustment: Ongoing monitoring of complaints management to ensure that it complies with current regulatory requirements and is continuously improved.
- Reporting and feedback: Development of a reporting system to regularly inform management and relevant departments about the status and results of complaints management.
