ISO 9001:2015's Clause 9.1.1, titled "General," falls under the broader category of monitoring, measurement, analysis, and evaluation. This clause provides a foundational framework that compels organizations to establish, implement, and maintain procedures for monitoring and measuring the effectiveness and performance of their Quality Management System (QMS). Here's a detailed breakdown:
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Determination of What to Monitor and Measure: Organizations are required to determine the specific metrics and parameters relevant to the effectiveness and performance of their QMS. This involves identifying key areas and processes critical to quality objectives and customer satisfaction. This also relates to clause 4.4.1.c
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Methods for Monitoring and Measurement: The clause necessitates that organizations decide on the methods for monitoring and measuring these parameters. This includes determining how data will be collected, when the measurement processes will occur, and ensuring that the methods are suitable for their intended purpose. It implies that the chosen methods should be capable of producing valid and reliable results.
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Evaluation Against Criteria: Organizations must evaluate the information and data obtained from these monitoring and measurement activities against defined criteria. These criteria are established in accordance with the organization's quality objectives and requirements in section 6.2.
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When to Perform Monitoring and Measuring: The timing and frequency of monitoring and measuring activities are crucial. Organizations must decide when these activities should be carried out. This decision should be informed by the need to ensure timely information is available to monitor performance and make informed decisions.
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Analysis and Evaluation: Beyond merely collecting data, organizations are required to analyze and evaluate this data to ascertain the health, effectiveness, and efficiency of the QMS. This analysis aids in identifying opportunities for improvement, making necessary adjustments, and ensuring that the organization meets its stated quality objectives and satisfies customer requirements.
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Documented Information: Clause 9.1.1 also underscores the importance of maintaining documented information as evidence of the results. This documentation serves as a record of the monitoring and measurement outcomes, providing a basis for analysis, evaluation, decision-making, and demonstrating conformity to the QMS requirements.
By fulfilling these requirements, an organization ensures a systematic approach to continuous improvement, aiming for increased customer satisfaction and enhanced quality performance across all operations.