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ISO 9001 Blog

Mark Hammar

How to implement the Check phase (performance evaluation) in the QMS according to ISO 9001:2015

Performance evaluation has been an important part of ISO 9001 for many years, and this importance is highlighted in the new version, ISO 9001:2015, by having an entire main clause dedicated to this topic. Performance evaluation is the critical Check step in the Plan-Do-Check-Act (PDCA) cycle that ISO 9001 is based on, and it is only through this step that you can determine if your Quality Management System (QMS) is functioning properly, or if changes are needed to meet the requirements.

In many ways, Clause 9 Performance Evaluation contains many of the same requirements from previous versions of ISO 9001 that relate to the topic of performance evaluation; however, the new standard has combined these into one clause. There are three main sub-clauses that discuss what performance evaluation you need to do in your QMS. These three elements are the way that you can ensure that all processes meet the requirements that have been deemed important within the QMS.

To learn more about the PDCA cycle in ISO 9001, see this article: Plan-Do-Check-Act in the ISO 9001 Standard.

Monitoring, measurement, analysis, and evaluation

The whole purpose of this first sub-section on performance evaluation is to have the organization first determine what in their processes need to be measured, how and when to measure these aspects of the process, and finally, when to analyze and evaluate the measurements. By doing this, you can continually monitor the critical aspects of your process. This can inform the process owner whether the process is functioning well – for example, using the accuracy of the inventory management in the purchasing and stock control process as a critical indicator of stock control.

Analysis and evaluation of the data collected are critical to making sure the processes are functioning as per the requirements. This analysis is an important part of the process; if it is not done, then you are just collecting data for no reason, which is an expense that will do no good for your QMS. In addition, the ISO 9001 requirements identify customer satisfaction as a critical performance indicator for the company that an organization needs to monitor, analyze, and evaluate.

For some more information on how monitoring and measurement works in the new standard, see this article on Analysis of measuring and monitoring requirements in ISO 9001:2015, and to learn about how this is used in decision making, check out Monitoring and Measurement: The basis for evidence-based decisions.

Internal Audit

As always, the internal audit is an important part of evaluating the performance of your QMS processes. This process will look at the practices and records for each process in your QMS to see that it meets the requirements of both the organization and the ISO 9001 standard, and that the QMS is effectively implemented and maintained. This is one of your best tools to identify the need for corrective actions, but also to identify opportunities for continual improvement of the QMS processes.

For a quick overview of how internal audits work in the QMS, take a look at 13 Steps for ISO 9001 Internal Auditing using ISO 19011.

Management review

If the internal audit is the best way to look at the implementation of the QMS processes, then management review is the best way to look at the overall QMS system to ensure that the processes are effectively integrated together. Management review is designed to look at the overall QMS performance indicators so that top management can see where the system is functioning well and where it needs improvement, and assign the necessary resources to create the improvements needed to maintain and modify the system.

For more information on how management review works, see this blog post on How to make Management Review more useful in the QMS.

The importance of performance evaluation

The reason that performance evaluation is important is to gather the necessary information required to make decisions based on facts, not conjecture. By properly gathering and analyzing the real data of the QMS, you are able to make real improvements rather than guessing what you can do better. It will also allow you to determine if the changes made worked to provide sustained benefits for the organization and stakeholders. Gather the appropriate performance data and you will know when and where you are improving, which is why you are implementing ISO 9001 in the first place.

To help you on your transition to ISO 9001:2015, you may find some help by reading this white paper on the  Twelve-step transition process from ISO 9001 2008 to 2015 revision.

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