How to monitor and measure products and processes in ISO 13485

monitor and measure processes

Importance of monitoring and measuring

You are a medical device company, and you have implemented your eQMS. Well, to monitor and measure are must if you want your QMS to work effectively. In ISO 13485, it’s defined in what different areas they should be highlighted.

It focuses on the quality of the product or services. It helps us to see if our product met our expectations. By collecting data from our monitor and measurement process, we get information on what needs to be improved.

How to monitor and measure?

If you have chosen the right eQMS, monitoring and measurement of products and processes can be easy. Before you start to monitor and measure, a few things need to be done. You need to establish, then document what are your product or process expectations and acceptance criteria. By doing that, you will know how your product or process should look like and does it need correction.

Your product will be compared with the acceptance criteria. It’s based on your checklist after your product comes out from the production line. A checklist is here to help you out to see if your product complies with the requirements you set.

Where to start?

Firstly, start by listing your QMS processes as well as planned results for each.

Secondly, collect and collate information about each of the above processes’ performance (in relation to the planned results).

This should be an ongoing process. This should allow you to reach conclusions and take action as necessary. Make sure each process contains a metric.

For instance, within 30 days, nonconformity reports from your medical device need to be closed. Periodically review your metrics data, typically during management review. 45 is the average number of days to close a nonconformity report.

Of course, corrective actions are required, which you will determine later. You should initiate the corrective action process and determine the root cause of the issue (why your nonconformity reports take so long to be closed).

KPI (Key Performance Indicators)

Basically, you need to identify Key Performance Indicators for your processes so you can compare expectations and reality. KPIs specify what is measured and assessment techniques.

In conclusion, it shows you details of how and when it will be measured. KPI is a type of measure. It’s used to define and evaluate how successful an organization is. Typically, is expressed in terms of making progress towards its long-term organizational goals.


Information and data rising from the monitoring and measuring actions shall be investigated and evaluated. Sometimes, it’s used as an appropriate statistical technique.

This analysis has a great benefit to the organization and shall be used in various ways to evaluate the conformity of products and services to specifications, level of customer satisfaction, performance and evaluation of the quality management system, any need for improvement of the quality management system, etc.

To improve the products, processes and QMS you can use these factors as inputs to the management review.

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2 replies to “How to monitor and measure products and processes in ISO 13485”

  1. Costa J. says:

    I think it depends on your company.

  2. Bill says:

    I was just curious, is this applicable for any medical device?

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