ISO 9001 Clause 9.1, "Monitoring, measurement, analysis, and evaluation," is expanded in clause 9.1.1 General. It is a crucial aspect of the quality management system that ensures organizations systematically assess their performance.
Key Components of ISO 9001 Clause 9.1.1
a) Identify what is required to be measured and monitored
The organization must identify the aspects of its processes, products, and services that are critical for ensuring conformity to requirements and for achieving customer satisfaction. This involves determining what data and information are essential to understanding and evaluating the performance of the quality management system.
Example: In a manufacturing context, critical parameters like product dimensions, defect rates, and production cycle times might be identified for monitoring and measurement.
b) Determine the methods for measurement, analysis, monitoring, and evaluation that are required to guarantee accurate results
The organization needs to establish clear and effective methods for collecting data, conducting measurements, and performing analyses. These methods should be robust and reliable to ensure that the results obtained are accurate and meaningful.
Example: If the organization is monitoring customer satisfaction, methods could include customer surveys, feedback forms, and analysis of customer complaints.
c) Determine the time for the monitoring and measurement to be done
There should be a defined schedule for when monitoring and measurement activities occur. This schedule might be based on the organization's processes, project milestones, or other relevant factors.
Example: If a company is monitoring the performance of a software system, it might conduct regular monthly assessments.
d) Determine the timeline for the analysis and evaluation of the monitoring and measurement results
In addition to determining when the data is collected, there should be clear guidelines on when and how the collected data will be analyzed and evaluated. This ensures that the organization doesn't just gather data but derives meaningful insights from it.
Example: An organization might set a quarterly review to analyze trends in customer satisfaction data and identify areas for improvement.
Assessment of the quality management system's efficacy and performance
This involves assessing how well the quality management system is working in practice. It goes beyond just monitoring and measurement to consider the overall effectiveness in meeting organizational objectives and customer requirements.
Example: An organization could assess how effectively it's meeting quality objectives, adhering to compliance requirements, and responding to customer feedback.
Maintain appropriate documented information
The organization needs to keep records of the results obtained from monitoring, measurement, analysis, and evaluation. This documented information serves as evidence of the organization's performance and provides a basis for decision-making and improvement.
Example: Records might include reports on product quality inspections, summaries of customer satisfaction surveys, and analyses of process performance.
ISO 9001:2015 Clause 9.1 Monitoring, Measurement, Analysis and Evaluation
In summary, ISO 9001 Clause 9.1.1 emphasizes the importance of a systematic approach to monitoring, measurement, analysis, and evaluation to ensure the ongoing effectiveness of the quality management system and the satisfaction of stakeholders.