The ISO 9001:2015 Quality Management System has always depended on regular monitoring and measurement (QMS).

To ensure that your Quality Management System (QMS) meets the requirements you have set for your processes, as well as your products and services, these requirements for gathering data are essential.

In this post, we will discuss ISO 9001’s evidence-based decision-making and the new monitoring and measuring requirements of ISO 9001:2015.

In ISO 9001, what does it mean to make decisions based on evidence?

One of the seven pillars of the QMS standard, evidence-based decision making, is a cornerstone of ISO 9001. Instead of making educated guesses about what needs to be done in your QMS, you should rely on accurate data.

While there are no particular requirements for evidence-based decision-making in the ISO 9001 clauses, there are requirements for senior management assessment of the system based on data; this is where the monitoring and measurement results are important.

Because of this, comparing actual results with anticipated outcomes can be a useful tool for monitoring progress toward the goal of improving the overall performance of a system or process.

You need proof to make decisions based on this as a primary concept. You can rely on the outcomes of monitoring and measuring to support this claim.

Here are some good points on how to meet the ISO 9001 standards by understanding the seven quality management concepts that guide the standard.

What is the Purpose of Monitoring and Measuring?

Because, as you can see, if your firm is aiming to increase its efficacy and efficiencies through evidence-based decision-making, the evidence needs to be reliable and adequate.

Implementing a Quality Management System that incorporates monitoring and measurement can help to guarantee that the evidence used to make decisions satisfies the demands of those who are making them effectively and efficiently.

In order to make certain that the QMS is achieving its intended goals, it is necessary to track and measure each step of the quality management system’s operation. The purpose of a QMS is to be able to improve the process, and the first step is to ensure that it is acting as designed.

When results don’t match expectations, it’s critical to correct the process and compare actual results to those anticipated in accordance with the objectives.

When it comes to measuring the quality of your design and development process, for example, you might consider tracking how many design changes are required because of design flaws.

It’s obvious to the process owner when this statistic deviates from a previously agreed-upon level that something has to be done about it. In the next step, management reviews the monitoring and measuring findings to determine whether or not a process needs to be restructured.

Monitoring your process for corrective actions to ensure no repeat problems, reviewing internal audit results that monitor processes, and reviewing the measurements for product conformance to ensure that non-conforming product is reduced are some examples of the monitoring and measurement management review.

The QMS also includes the monitoring of customer satisfaction, so that you may better understand how your customers view your capacity to meet their needs. This will aid in the enhancement of both the QMS and the company’s reputation with customers, as well.

Monitoring and Measuring in Accordance with ISO 9001:2015

Some monitoring and measurement techniques may be integrated into other procedures.

There may be information included in your purchase process about the suppliers’ monitoring (such as delivery time and the percentage of the approved products received) as well as instructions for employees on how to measure whether or not items and services fulfill your standards.

Even if your organization has a single procedure for monitoring and measuring, it is not a statutory requirement of the ISO 9001:2015 standard to have this approach in place.

Monitoring and measuring are crucial phases that could be included in a procedure.

• Find out where you need to monitor and measure your processes.
• You need to figure out what kind of monitoring or measuring you’ll be using.
• Each situation needs specific monitoring and measurement equipment.
• Ensure that all monitoring and measurement equipment is calibrated or verified as appropriate.
• Decide how and by whom data will be collected for monitoring and measurement.
• Find out how and by whom data from monitoring and measurements will be analyzed and interpreted.
• Make sure top management is aware of how monitoring and measurement data is escalated when it is necessary.

Is there a specific section of ISO that outlines the standards for measuring?

“Monitoring, measurement, analysis, and evaluation” is the ISO 9001 clause 9.1 referred to as “Monitoring, measurement, analysis, and evaluation” – this clause includes requirements for QMS measurements, but it also emphasizes the importance of conducting measurement reviews.

Clause 9.1 of the standard does not call for you to measure everything you do in the Quality Management System (QMS), but rather to examine the data you acquire to see if action is required. You don’t need to collect data if you don’t intend to use it; the purpose of collecting data is to learn something.

Clause 6.2 of ISO 9001:2015 states that the quality objectives are a vital aspect of the QMS that requires precise measurement. These quality goals and plans for achieving them are one of the primary ways to strive toward improvement.. Monitoring and measuring data are used to make decisions about which goals to set and to keep track of how well they’re progressing.