To verify whether the organization has determined what needs to be monitored and measured, and the methods for monitoring, measurement, analysis, and evaluation to ensure valid results, follow these steps:

Identify What Needs to Be Monitored and Measured:

Review the organization’s quality management documentation, including the quality objectives and key performance indicators (KPIs). Check if there are clear definitions of the processes, products, and services that need to be monitored to ensure quality standards are being met.

Look for a list or inventory of areas that are critical for product/service quality, such as production processes, customer feedback, compliance with regulatory requirements, and supplier performance.

Evaluate Methods for Monitoring and Measurement:

Check if the organization has documented methods or procedures that outline how monitoring and measurement will be conducted. These should include specific techniques, tools, or instruments to ensure the accuracy and validity of the results. Examples could include statistical process control (SPC), customer satisfaction surveys, or product testing procedures.

Ensure that the organization has defined how to assess the validity and reliability of the data collected, and that the methods chosen are appropriate for the type of monitoring required.

Review Frequency and Timing of Monitoring and Measurement:

Verify that the organization has established clear schedules or intervals for monitoring and measurement activities. There should be documentation that specifies when measurements or assessments are to be conducted for various processes or products, such as daily, weekly, or after each production batch.

Check for Analysis and Evaluation Procedures:

Review the documented procedures for the analysis and evaluation of collected data. Confirm that there is a process to analyze the data to ensure that results are valid, reliable, and relevant. This could include reviewing data interpretation methods, statistical analysis techniques, or decision-making criteria.

Ensure that there is a defined process for evaluating the results of monitoring and measurement activities in relation to performance and effectiveness, such as assessing product conformity, customer satisfaction, or overall system effectiveness.

Confirm Retention of Documented Information:

Ensure that the organization retains documented information on the monitoring, measurement, analysis, and evaluation results. This should include records of what was monitored, how it was measured, the evaluation results, and any corrective actions or improvements made as a result of the evaluation.

By confirming that these elements are in place and properly documented, you can determine if the organization is compliant with the requirements for monitoring and measuring, as outlined in ISO 9001.