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Servicing Activities vs. Compliant (ISO 13485 Chapter 7)


Service activities are similar to Installation or Assembly services. However, some devices or equipment do not require servicing, they are often tagged as disposable devices. Nevertheless, should a device require servicing, then it is imperative that it should be stated in the quality manual.

While disposable devices can be described as an exclusion in the quality manual, devices that require servicing should have clearly stated procedural guidelines on its service activities.

Now, with each servicing, a record needs to be created detailing the nature of the service. Likewise, the installation records need to be updated accordingly. Also, information on tests, calibration, or inspection are to be noted. Very similar to the production of the device for the first time, a Device History Record (DHR) record is being logged for each product serial number.

Orcanos eQMS system grants you the ability to record both the installation and the production history record of the device, with a strong link to the procedures and processes and supplier qualification processes.

Standard procedure dictates that there be data testing before and after servicing and the process be documented. Orcanos design control system records the test plan and test results with the ability to report a None Conformity Report (NCR) during the testing state. In so doing, both manufacturers and customers will be able to track the performance of the device prior to the moment of manufacturing or service. Also, it will help identify any prior issues or faults. Finally, it helps to assure all parties that the device was in perfect working condition post-production or servicing.


In the medical device industry, it is possible that manufacturers in the process of servicing a system or device might ignore the role of complaints. While there is nothing wrong with servicing, it is crucial to leave room for complaints to ensure an effective CAPA. Hence, there should be a clear distinction between service systems and complaint systems. Orcanos eQMS comes with a built-in complaint management system that is separated from the service system. Orcanos CAPA management system allows integration natively with the complaint management system as well with the Risk system, all together empower the organization quality management capabilities.

For example, analyzing a diagnostic testing lab equipment. Picture a system that runs a buffer and requires the user to refill it using a buffer bottle. Now, suppose that the service engineer discovers leaks 62% of the time and fix it as part of their service call.

Then, it means that they would have successfully avoided a complaint system that would help track the issue with the product. As a result, there would be no feedback to the CAPA system or manufacturer that would alert them to the flaw in the product.

Major Issue

Such unclear roles in servicing can constitute a major problem in the long term. Therefore, it is important to avoid such issues by defining the roles of servicing and creating a way to have issues beyond servicing reported using the compliant system.

Also, all services and installation should be recorded and updated regularly.

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