ISO 9001: 2015 and “Effectiveness”

Control chart, data, analysis


ISO 9001:2015 references measurement of “effectiveness” throughout the standard. My question is what methods/techniques are typically used to measure “effectiveness”? Is it purely a quantitative analysis of metrics, or does it also involve subjective evaluation that may not be driven by statistics or metrics? Also, is it expected that effectiveness be measured for each process/procedure?


Thank you for your question.

Let’s begin with the definition of effectiveness from ISO 9000:2015.

Effectiveness is “the extent to which planned activities are realized and planned results are achieved.”  This definition requires that you know what the expected outcome (or objective/target) you want for a given task, project or process.  The first step is to know what you want to achieve, and then ask yourself what would be the best means to determine the extent to which that objective was met?

Yes, it is expected that effectiveness be (suitably) measured for each process. This is at the heart of the Plan-Do-Check-Act cycle.  Also, please read ISO 9001 Clause 4.1 and Clause 0.3.

As far as quantitative vs. qualitative metrics are concerned, you will have to decide what best measures the outcome of the process.  Also consider the cost of data collection.  Often, easy-to-collect qualitative data can suffice.   And don’t be deterred if quantitative data cannot be obtained.  As Dr. Deming so wisely stated: “Sometimes we have to settle for inexact measures of exactly the right things”.

Denis Devos

A Fellow of the American Society for Quality
Devos Associates Inc.
(519) 476-8951

For more information on this topic, please visit ASQ’s website.

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