Every successful Quality Management System enforces the concept of collecting and analyzing data to carry out operations efficiently, reduce nonconformities, and continuously improve. Clause 9.1 of the ISO 9001 QMS Standard is titled “Monitoring, Measurement, Analysis and Evaluation”, which outlines how critical this step is to finding success and compliance.

The primary use of collected data is to compare actual process results with your organization’s established quality objectives, assessing the effectiveness of improvements. To make informed decisions, organizations must rely on concrete evidence, which is provided through consistent monitoring and measurement.

In other words, collecting data is essential to ensuring that your QMS aligns with the defined requirements for your processes, products, and services, helping maintain compliance and effectiveness. Let’s take an in-depth look at what it means to monitor and measure with ISO 9001, as well as how doing so can significantly improve your organization’s operations.

Monitoring & Measuring with ISO 9001

Defining Monitoring vs Measuring

Monitoring and measurement are closely linked in ISO 9001 but serve distinct purposes. Monitoring involves continuous observation to track changes, detect trends, or identify potential issues, acting as a form of surveillance. Measurement, on the other hand, quantifies specific characteristics, such as dimensions or capacity, to determine actual values and assess compliance with set requirements.

For example, monitoring can help detect when a process is approaching a critical limit, such as tracking tool wear in machinery or using alarms to signal rising temperatures that could impact performance. Measurement, however, provides precise data on a characteristic’s actual value, like recording the exact temperature of a process to verify if it meets operational standards.

Both methods play a crucial role in quality management, offering different types of evidence for decision-making. They can also be applied to product monitoring and measurement, ensuring that processes and outputs align with required quality standards.

ISO 9001 Standard Clauses

ISO 9001 Clause 9.1, “Monitoring, Measurement, Analysis, and Evaluation,” emphasizes not only the need to take measurements but also the importance of reviewing the collected data to determine if action is necessary. Data collection should serve a purpose; merely gathering information without analysis is ineffective. The key is to use the data to drive meaningful improvements.

A crucial area where accurate measurement is essential is in tracking quality objectives, as outlined in Clause 6.2 of ISO 9001:2015. These objectives, along with plans to achieve them, serve as a foundation for continuous improvement. Setting the right objectives and evaluating progress depends on effective monitoring and measurement, ensuring that the QMS drives real and measurable enhancements.

Monitoring and Measuring Practices

Effective monitoring and measurement within a Quality Management System (QMS) ensure that decision-making is based on reliable evidence. By consistently tracking processes and comparing actual results to planned objectives, organizations can identify deviations and take corrective action, ultimately driving improvement.

For example: a design and development team might measure the number of design changes required due to errors. If this number exceeds an acceptable threshold, it signals a need for process adjustments, which can then be addressed through management review.

Management reviews of monitoring and measurement results help determine necessary changes, such as reallocating resources or refining processes. This could include tracking corrective actions to prevent recurring issues, reviewing internal audit findings, or analyzing product conformance data to reduce defects. Furthermore, monitoring customer satisfaction provides valuable insights into how well the organization meets customer expectations, supporting both QMS enhancements and overall business success.

To effectively implement monitoring and measurement within your processes, start by identifying the areas where these activities are needed and determine the appropriate types of monitoring or measurement to use. Ensure that the necessary equipment for these tasks is available and properly calibrated or verified. Clearly define how and by whom the data will be collected, and establish a process for reviewing the collected data. This will improve the way your organization monitors and measures data, strengthening your management system overall.

Conclusion: Strengthen Your QMS With Monitoring & Measuring

Monitoring and measurement are fundamental to the success of any Quality Management System. By systematically collecting and analyzing data, organizations can ensure that their processes are performing as planned, identify areas for improvement, and drive continuous growth.

Implementing effective monitoring and measurement practices, as outlined in ISO 9001, enables businesses to make informed decisions, enhance product quality, and maintain compliance. By aligning these activities with quality objectives and regularly reviewing the results, organizations can strengthen their QMS and achieve long-term success.

The ISO 9001 Group offers ISO 9001 Quality Management System Consulting services. Our experienced consultants can assist your organization in designing and implementing an effective, certification-ready management system. Contact us today!