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8 January 2024
One of the underlying principles of ISO 9001:2015 is Evidence-Based Decision Making. Clause 9 of the standard provides the foundation for it. In this clause, measuring and evaluating data is paramount. As a result, most of the requirements outlined in this clause deal with ways of generating important data. Additionally, there are sections on analysis and management reviews that help decision-makers interpret the data generated. We'll give you a brief and easy-to-understand overview of this clause.
Measurement and monitoring are indispensable activities for ensuring conformity to requirements and driving continuous improvement. Within Clause 9, ISO 9001:2015 requires that organizations define, plan, and implement measurement and monitoring activities. These activities include monitoring product characteristics, production processes, delivery times, and customer feedback, among others. Measuring and monitoring activities are the first step for organizations to base their management decisions on factual data rather than intuition or guesswork.
Customer satisfaction is a top priority for any organization, and Clause 9 recognizes this by placing significant emphasis on gathering and analyzing customer feedback. As part of a comprehensive quality management system, organizations must monitor information relating to customer perception. This involves soliciting customer feedback to identify areas where customer expectations are not being met.
Note that this requirement goes beyond gathering objective information on whether or not the organization has fulfilled their customers' requirements. By actively seeking feedback and measuring customer satisfaction, companies can gauge the extend to which they fulfilled requirements from the customer's perspective.
One of the most important aspects of Clause 9 is the proper analysis of data generated through the monitoring and measurement activities. Data analysis is a foundation for continuous improvement, as it allows organizations to identify areas for improvement, take corrective action where necessary, and monitor the effectiveness of any changes made.
To undertake the analysis required, organizations can employ various statistical and analytical techniques. For example, control charts and Pareto charts help identify areas with high variability or disproportionate issues. Organizations can also use histograms and scatter plots to help identify trends and correlation between variables, making it easier to connect the dots and identify areas for improvement. These insights inform fact-based decision-making and help drive continuous improvement initiatives.
Clause 9 emphasizes the importance of conducting internal audits at planned intervals. These audits provide a systematic and objective evaluation of an organization's quality management system, focusing on the system's effectiveness and adherence to ISO 9001 requirements. Internal audits are not meant to target individuals; rather, they serve as checks on the overall system and processes in place. By conducting regular internal audits, organizations can identify any shortcomings or areas for improvement, guiding them towards a more robust and efficient quality management system.
Management reviews are a high-level periodic assessment of an organization's quality management system and typically arranged with senior leadership. The objective is to determine the effectiveness of the system in achieving the desired quality objectives and to identify opportunities for improvement. Clause 9 of ISO 9001:2015 requires that the management reviews encompass the review of trend analysis, internal audit results, customer feedback, and other relevant metrics.
By conducting regular management reviews, senior leadership can identify areas that require attention, allocate resources, and make decisions that drive organizational improvement and success.
Clause 9 of ISO 9001:2015 outlines the requirements for organizations to measure and evaluate their performance. By implementing the provisions of this clause, organizations can measure, monitor, and analyze data to drive continual improvement, enhance customer satisfaction, and ensure the effective functioning of the quality management system. The focus on measurement, analysis, and continuous improvement underscore the importance of making decisions based on factual data and striving for excellence.
For a comprehensive overview of all ISO requirements and their interconnections, please see our article on ISO 9001:2015 Requirements. Alternatively, please consider our comprehensive ISO 9001:2015 Foundation Training online course to deepen your understanding and skills related to performance evaluation and all other requirements.
Training Manager, Instructor and Lead Author
Simon is the lead author of our ISO 9001 courses, templates and instructions, and is a passionate contributor to our articles and learning resources.
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