Understanding Section 9.1
Monitoring, Measurement, Analysis and Evaluation
This is an educational article on Section 9.1 of ISO 9001, entitled “Monitoring, Measurement, Analysis and Evaluation”.
The purpose of this article is to give you an understanding of what Section 9.1 requires.
This article is directed towards:
- Those responsible for compliance to section 9.1.
- Those responsible for MMAE activities.
- Others interested in understanding section 9.1.
Section 9.1 is entitled “monitoring, measurement, analysis and evaluation” As this is a mouthful, I tend to call it MMAE for short.
Let’s start by defining what it means to monitor, measure, analyze and evaluate, and then we will discuss what you should monitor, measure, analyze and evaluate.
To monitor means to determine the status of an activity, process, or system at different stages or at different times.
In other words, you may need to continually monitor the activity, process or system, in order to control or measure it according to your plan.
To measure means to determine a value in relation to a particular metric, such as a quantity, percentage, statistical deviation, and so forth.
In other words, you may need to measure an activity, process, or system to determine its performance.
To analyze means to examine data or information methodically to identify relationships, trends, or other patterns.
In other words, you may need to analyze data to know how to improve performance.
To evaluate means to draw a conclusion or make a judgment about the implications, meaning or significance of the data or information.
In other words, evaluating the results of monitoring, measuring and analysis will empower you to make data-based decisions for your organization.
So with those definitions you can see how one leads to the other until you get an actionable conclusion.
You need to monitor to know when to measure.
You need to measure to provide data for analysis.
You need to analyze to draw out significant data.
You need to evaluate to determine the implications of the data.
Finally, in the end, you should know what action, if any, should be taken as a result of the data.
And this is called data-based decision making.
Section 9.1 requires you to plan:
- What needs to be monitored and measured
- The methods for MMAE needed to ensure valid results
- When the monitoring and measuring will be performed
- When the results will be analyzed and evaluated
All of this so that you can make data-based decisions and take action to improve the effectiveness of the quality management system.
Also, you are required to retain appropriate documented information as evidence of the MMAE results.
The standard does give you some guidance on what should be monitored and measured.
In section 9.1.3 you are required to have data to analyze and evaluate the following:
- Conformity of products and services
- The degree of customer satisfaction
- The performance and effectiveness of the quality management system
- If planning has been implemented effectively
- If risk planning has been effective
- The performance of external providers
- The need for improvements to the quality management system
With regards to determining the degree of customer satisfaction, you are required to make plans for obtaining, monitoring, and reviewing customer satisfaction levels.
And of course, then you make data-based decisions and take action to enhance customer satisfaction.
For more information on how to implement this section, watch our implementation videos for section 9.1, and review our document templates for examples.