What mostly reflects the effectiveness of the Quality Management System is monitoring and measurement focus on the quality of your medical device.

The ISO 13485 Standard defines several sections in which monitoring and measurement should be emphasized highly addressed.



The ISO 13485 Standard requires the evaluation of feedback regarding the use of the medical device. The aim is to identify early as possible any quality problem or warning related to the medical device. Standard recommends you to plan the systematic method for achieving early identification.

Feedback is here to practically define, document, and implement methods for monitoring and controlling the medical device. The best way to achieve that is to use data that were collected in the postproduction phase, or utilizing post-market surveillance to detect quality problems. In case of quality problem identification, there is a procedure for handling and submitting for further improvement process.

Feedback doesn’t need to be only negative; it could be positive or suggestive regarding your medical device. Bear in mind that the data collected via feedback methods are to be used at later stages as inputs for processes of analysis of data.


Complaint handling

Complaint handling is just another way of receiving a sort of feedback. But it’s still unique because it’s the only quality process where you communicate directly with the customer. One of the key challenges is to implement a proper management strategy for tracking and monitoring all complaints that you receive. In most cases, every complaint concerns a specific product of your company and must be treated as a singular event – a problem reported by a customer for a single type of product.

But it’s good to keep in mind that some complaints must be reported to authorities, therefore they will require further investigation and notification of regulatory authorities.


Reporting to regulatory authorities

You have to report to regulatory authorities when a complaint is considered to reach the criteria of a field safety notice. It must be reported promptly and documented. Your medical device company should incorporate regulatory guidelines for field safety notices as part of the complaint-handling procedure.


Internal audit

It’s known as an activity that comes out as the most effective action taken regarding monitoring, analyzation, control, and improvement of your QMS. Its aim is about status reports regards your QMS. The audits evaluate whether the activities are performed and how well they are performed.

Of course, it’s expected that your medical device company will define periodic intervals for conducting internal audits.


Monitoring and measurement of processes

Measuring processes are mentioned many times throughout the ISO 13485 standard – quality manual, quality objectives, management responsibility and control of production, etc. This part of the standard is saying you have to establish and implement appropriate methods for monitoring processes of your QMS, and where is relevant to apply defined methods.

When monitoring quality processes, you are required not only to verify they are defined and have been performed but also to evaluate the results and whether processes have achieved their goals.


qmsWrapper provides a Search and Report tool that allows you to track the progress of all processes initiated in your company, and it will make monitoring on them very easy. You can check whether certain process achieves planned results, and to take appropriate actions in time, if determined it doesn’t.


Monitoring and measurement of the product

Monitoring and measuring activities of products are the necessary controls to ensure the medical device performs as intended. It’s expected that you are doing it throughout the different realization processes at adequate levels.







Comments (2)

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I wondered if all these lessons will be available for download, like in whitepaper or something?

Hi Brandon, yes soon we will create the pdf for download.