ISO 9001 Knowledge base

Analysis of measuring and monitoring requirements in ISO 9001:2015

Monitoring and measurement is one of the key elements of the ISO 9001:2015 standard, as it was in the previous 2008 standard. If you consider this subject, it is not difficult to see why. Firstly, the two elements will now be defined separately as follows:

  • Monitoring: the status of a system, process, or activity
  • Measuring: the process to determine a value

This is broadly a change in terminology, but let us consider what this means. For your Quality Management System (QMS) to perform effectively, you will need to have evidence around which you can base your decision-making process and improvements. Measuring and monitoring is the critical process with which you can gather that evidence, so much so that they are separated in the 2015 version of the 9001 standard. Therefore, it is clear that in order to be effective, you must also be able to plan, review, and take action on the measuring and monitoring processes and resources you need to ensure success. But, what does that really mean to your organization?

Monitoring and measuring: The difference in the 2015 standard

The 9001:2015 revision of the standard mentions that companies will be required to use “Information as evidence of fitness for purpose of monitoring and measurement resources,” and also pay attention to “results of monitoring and measurement activities.” This is more prescriptive than the parts of clause 8 in the ISO 9001:2008 standard that deal with the subject, which basically only say that monitoring and measuring shall be used and that “methods shall be determined” to do so. Therefore, within section 9 of the 2015 revision of the standard, and supported by the aspiration of continual improvement that underpins ISO 9001, it is clear that the standard requires us to do several things effectively:

  • plan resources to ensure our measuring and monitoring processes are suitable and effective
  • use evidence on the basis of the above process to make decisions
  • facilitate continual improvement through our QMS based on the tangible and rational evidence that is the output from the process

Therefore, on that basis, it is possible to see that the respective monitoring and measurement processes are key to two of the overriding principles of any QMS: customer satisfaction and continual improvement. So, with the new monitoring and measurement processes in mind, how do we ensure we deliver just that?

Using effective monitoring and measurement to deliver customer satisfaction

The foundation of an effective QMS is to have processes in place that ensure that the customer’s expectations are met and exceeded. Let’s use an example of a hypothetical organization that is manufacturing a consignment of computers to a customer, and illustrate where the new definition of monitoring and measuring separately fits in:

  • The computer is manufactured to the customer’s agreed and documented specification. (Can the organization supply the resources and organize the measurement initially to ensure that the specified and actual products are one and the same? If “yes,” do we have the resources and process to ensure that the output then remains constant through ongoing monitoring to protect both our performance and reputation and the customer?)
  • The computer is ready for final testing before shipment to the customer. (Can the organization employ the resources and design the process to ensure that the performance and characteristics match the expected performance from the customer specification? This is a hard measurement that will take place, and monitoring can be employed if the initial answer is “yes.”)

So, as we can see, there is an element of using these two actions in tandem even though the 2015 standard distinctly separates them out. What is clear is that effective resourcing, implementation, and information gathering of our measuring and monitoring processes are critical to the integrity of the organization’s product and meeting our customer’s expectations. So, is that it?

Using evidence-based data to your benefit

Whether you are trying to drive down the number of customer complaints, as you can see in this previous article: Handling customer satisfaction with code of conduct and complaints procedure, or any other issue within your QMS, the more accurate and detailed evidence you have to do this, the more effective your QMS will be. Therefore, we can see that accurately and efficiently planning, resourcing, and capturing accurate evidence from all strands of your QMS is critical to your ability to meet customer requirements and demonstrate continual improvement.

Ensure that you commit the correct resources and planning to these processes, and you will find that meeting stated objectives, whether they are external or internal, will become easier. Continual improvement means happy customers, and if you can ensure that you meet and exceed customer requirements, your QMS is delivering the desired results.

Use our free  ISO 9001 Gap Analysis Tool to measure where your organization is in terms of ISO 9001 readiness.

Advisera John Nolan
John Nolan
John Nolan is a Fellow of the Institute of Leaders and Managers in the United Kingdom, and Prince 2 accredited with a background in Engineering and Electronics and Data Storage and Transfer. Having studied and qualified as both a Mechanical and Electronic Engineer, he has spent the last 15 years designing and delivering Quality Systems and projects across many sectors in the UK, including both national and local government.