What the clause requires
Clause 9.1.1 organizes the measurement of the whole system. The organization determines what needs to be monitored and measured, the methods needed to ensure valid results, when the monitoring and measuring is to be performed, and when the results are to be analyzed and evaluated. It then evaluates the performance and the effectiveness of the quality management system and retains appropriate documented information as evidence of those results.
In practice this becomes a dashboard of indicators with a target, the source of the data, the collection frequency, an owner and a defined moment for analysis. Data quality matters more than the number of charts: an indicator calculated a different way each month cannot be compared with itself, and auditors routinely ask to see the calculation behind a number and to reproduce it from the raw records.
Measuring is not enough on its own, the results have to be analyzed. An indicator sitting outside its target for three months with no analysis and no action recorded is the most common nonconformity raised against this clause, and it is also the easiest one to avoid. The analysis feeds the evaluation required by 9.1.3 and, from there, the management review in 9.3.
A simple rule helps decide what deserves to be measured: every indicator should answer a question that somebody actually uses to make a decision. If nobody would change anything based on that number, it can probably leave the dashboard, freeing attention for the few indicators that really drive behavior in the organization. Applying that filter once a year usually shrinks the dashboard considerably and makes the remaining indicators far more likely to be discussed rather than merely published.
What changes in ISO 9001:2026
In ISO 9001:2026 the core requirements of section 9 remain, with more emphasis on making better use of data to support decisions. See everything that changed in the revision.
What the auditor asks to see
- List of what is monitored and measured, with the method used, the frequency of collection and the owner
- Indicators carrying a defined target and enough history behind them to show a trend
- A stable, documented calculation method for each indicator, reproducible from the raw records
- Records of the analysis of results, including the actions taken whenever a target was missed
Where companies most often get it wrong
- Indicator published with no target defined and nobody made responsible for it
- Result sitting outside the target month after month with no analysis recorded anywhere
- Formula of the indicator changed silently, breaking any comparison with earlier periods
- Measuring and publishing things that nobody ever uses to make a decision
Example of a nonconformity
- Requirement
- ISO 9001, 9.1.1 d): determine when the results from monitoring and measurement shall be analyzed and evaluated.
- Evidence
- The assembly rework indicator, target 3%, recorded 5.8%, 6.4% and 7.1% between April and June 2026; there is no record of analysis or action, and the organization has not defined when this indicator is to be analyzed.
- Finding
- Monitoring and measurement results are neither analyzed nor evaluated.
How to comply using PrismaBiz
Ready-made templates for this clause
Frequently asked questions
How many indicators should I have?
As many as are needed to know whether the processes and the quality objectives are working. A few indicators that are actually analyzed are worth far more than dozens that nobody reads.
Does every indicator need a target?
Clause 9.1.1 does not use the word target, but without a reference point performance cannot be evaluated. In practice every relevant indicator ends up with one.
Where should the analysis be recorded?
In periodic indicator meetings, in the dashboard itself or in the management review, as long as the record shows the conclusion reached and the decisions taken.