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ISO9001 and the Monitoring, Measurements, Analysis and Evaluation Clause

Let's face it if you are working through ISO9001:2015 you already know that you need to monitor, measure, analyse and evaluate your quality management system, we talked about it way back in Clause 4.4 and again in Clause 6.2. You already understand why it's important so why is it here again in ISO9001:2015 Clause 9.1.1? I guess you could look at this as a broad-brush area but also remember that the 2015 version of the ISO9001 standard is based around the PDCA (Plan, Do, Check, Act) framework and this clause is about helping you frame up what is in the Check part of your framework.  

Clause 9.1.1 – General

The general part of clause 9.1 gives you 4 points that the organisation needs to determine, so these are conscious decisions that you must make:

  1. What needs to be monitored and Measured
  2. How you will carry out that measurement or monitoring in a way that means your results will give you valid results
  3. When the actual measuring will be done
  4. When your results from the measurements will be reviewed. (determining how is also a good idea)

The standard doesn't stipulate hard and fast requirements for frequency or type of measurements here, it's down to the organisation itself to figure that since every organisation is different you need to think about what the right process and frequency for you is.

The key things you are looking for here are how effective your quality management system is operating, where is it not giving, you're the results you need and of course what you will do about it, how are your products and services performing and what improvements you will make as a result of these feedback loops. After all if you don't act what is the point of collecting the data.

This clause does have the requirement for the organisation to retain documented information as evidence of the results of the monitoring you have carried out.

So how would you meet this clause? Well you would probably have a list of the processes (internal & External) that you think should be measured and the corresponding type of measurement you would apply, think carefully here about what value these measurements adds to your organisation and your quality management system. Measuring the quality output of your processes, fault levels would be another and what improvement activities you have undertake and where, for example if you found that your Returns process was cumbersome and customers hated it then you fixed it, record what you did, why and the results as part of meeting this clause.

Clause 9.1.2 Customer Satisfaction

There are as many ways of measuring customer satisfaction as there are types of coffee at my local coffee shop! So which one is the right way and what does ISO9001:2015 say about it?Well lets start with the easy one, ISO9001 says you will monitor customer satisfaction, actually it says you will measure their PERCEPTION to which their needs and expectations have been fulfilled. That word perception is critical to remember, the feedback you get will be 100% from their view point based on the data set that they have, on their customer experience with you. It is entirely up to the organisation how to do this, the standard gives some hints (surveys, feedback on delivered products, compliments, warranty claims and so forth)

The vast majority of organisations jump for Customer Surveys and believe that they are ticking off this requirement, you are not, and you are doing your organisation, and your clients a vast disservice. Certainly, use a survey to gather base data at specific intervals but the real value is in the conversation that you have with your clients. You can and should schedule regular meetings with customers or a representative sample of them if 100% isn't a possibility. It's this real life human interaction where you will get the most value and the real feedback, "I see you scored us a 6 out of 10 for delivery in our last survey, can we talk about that and what we need to do to improve". Keep a record of when the customer has mailed or called in and said thanks or provided a compliment – of course you should absolutely share these with your teams as much as you should share the negative feedback that you may receive. Understanding the levels of warranty claims coming in from a customer would also be a way of gauging the customer satisfaction, after all if they are returning 75% of what they get they are unlikely to be happy.

Clause 9.1.3 – Analysis and Evaluation

The final part of ISO9001:2015 Clause 9.1 is where you roll up all of that data you have collected as part of the monitoring and measurements phases and actually review it, understand it and make decisions about what you will do about it going forward. How you analysis it is entirely up to you as an organisation, you could use statistical trends and charts for example. I know one company who have turned these various inputs into a balanced scorecard approach to understanding the customer satisfaction of their organisation which is reviewed every 6 months (it started out at 3 months but has now grown to 6 months because they are comfortable that the data supports moving the frequency out to 6 months).

The standard while not directing you how to do the analysis does say that you SHALL use the analysis to evaluate a pretty decent list of things as follows:

  1. Conformity of Products & Services
  2. The degree of Customer satisfaction
  3. The performance of the Quality management system
  4. How well the planning of the QMS and actions have been implemented in your organisation
  5. How effective the actions you have taken to address the risks & opportunities that you have previously identified are.
  6. The performance of External providers
  7. The need for improvements in your quality management system


ISO9001:2015 Clause 9.1 Monitoring, Measurements, Analysis and Evaluation is a fairly large clause and needs careful consideration about what you are going to measure, why and of course how. You need to be prepared to act on what you find from the data you get and use that to drive the continuous improvement of your organisation. Understanding what your customers perception of your organisation and the products or services you provide to them is important as is understanding how you see your external providers performance. All of these factors then need to be considered to really meet the requirements of this clause.

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Thursday, 02 April 2020

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