To assess compliance with ISO 9001 clause 8.5.1, it’s essential to confirm that the organization’s production and service provision activities are performed under well-defined, controlled conditions. This involves checking if the organization has readily available documented information that clearly specifies the characteristics of the products or services being provided, as well as the expected results. This documentation should include detailed requirements, specifications, or process parameters necessary to meet quality standards, ensuring that all team members understand what is expected at every stage of production or service delivery. Availability of this information confirms that all aspects of the product or service are considered before work begins.

In addition, compliance can be verified by evaluating the organization’s monitoring and measurement processes. These processes should be applied at critical stages of production or service provision to ensure that all requirements and acceptance criteria for both process controls and final outputs are being met. Evidence of compliance would include records of inspections, measurements, or tests performed throughout the process, demonstrating that each stage is being assessed against established criteria. This approach provides assurance that issues are detected early, helping the organization to deliver conforming products and services.

Finally, verifying the competency of personnel is essential. This involves confirming that the organization has qualified and competent individuals carrying out each task within production or service provision. Competency records, such as training logs, certifications, or experience documentation, should be reviewed to ensure that individuals have the necessary skills and qualifications to perform their roles effectively. This evidence demonstrates that the organization has invested in skilled personnel, which is critical to maintaining control and consistency in the quality of products and services provided.