ISO 13485
Installation, delivery, ongoing inspection, preventive maintenance services & customer satisfaction.
Key aspects related to after-sales services and other post-market activities covered by ISO 13485
While the primary focus of ISO 13485 is on the design and manufacturing aspects of medical devices, it recognizes the importance of post-market activities and includes requirements related to areas such as installation, delivery, ongoing inspection, preventive maintenance services, and customer satisfaction.
Here are key aspects related to after-sales services and other post-market activities covered by ISO 13485.
Installation and Servicing
- Requirement: ISO 13485 requires service providers to have processes to ensure proper installation at the customer's site and provide necessary ongoing services to maintain the device's functionality.
- Solution: Medeq uses customised Checklists for all types of activities carried out by service teams, from installation at the customer's site to annual inspections and calibrations. Checklists can be created, modified or replaced at any time and all changes are recorded in the centralised document repository for tracking purposes. All completed checklists are linked to the device record and stored in the document repository. In addition, Medeq tracks and reports on scheduled maintenance activities with automated reminders if required.
Control of Servicing Processes
- Requirement: ISO 13485 requires organizations to establish controls for servicing processes, ensuring that these activities are carried out by qualified personnel and that any changes to the original design or manufacturing process are properly documented and validated.
- Solution: All activities carried out by service teams are recorded using Medeq’s electronic Job Card app and are linked to the device record and stored in the centralised document repository. These documents, stored as PDF files, as well as any completed checklists, are available in the centralised device service history at any time.
Complaint Handling and Customer Feedback
- Requirement: The standard mandates a systematic approach to handling customer complaints and feedback. This includes processes for investigating complaints, implementing corrective and preventive actions, and maintaining records.
- Solution: Medeq provides a centralised Ticketing system to record all requests and/or complaints from customers. Open tickets are tracked and automated emails can be sent to stakeholders when they are updated or closed. Automated alerts can be sent to management for Tickets that remain unresolved for too long.
Regulatory Reporting
- Requirement: ISO 13485 requires organizations to have procedures for reporting events such as product recalls, corrections, and other regulatory matters.
- Solution: All documents completed by service teams as well as records of communications between stakeholders can be stored in the centralised document repository. These documents are available at any time and can be sent via eMail or extracted into spreadsheet format as required.
It should be noted that the ISO 13485 standard is primarily focussed on documented and working business processes. While the features and functions available within Medeq can support and streamline such processes, they do not stand alone. The actual business processes still need to be designed, implemented and managed by humans.