Auditing ISO 9001:2015 Clause 9.0 - Performance Evaluation

by Walt Prystaj

When auditing ISO 9001:2015 Clause 9 (Performance Evaluation), the focus is on evaluating how effectively the organization monitors, measures, and analyzes quality management system (QMS) performance. Here’s a guide to auditing Clause 9, complete with objectives, key questions, and examples of evidence to examine.

Objectives

  1. Evaluate Monitoring and Measurement: Ensure processes are in place to monitor and measure QMS performance, including product and service conformity.

  2. Review Customer Satisfaction Efforts: Verify that customer satisfaction is monitored and analyzed for continuous improvement.

  3. Assess Internal Audit Processes: Confirm that internal audits are planned, implemented, and documented to assess QMS effectiveness.

  4. Verify Management Review Process: Ensure top management conducts regular management reviews and takes appropriate actions for continuous improvement.

Key Audit Questions by Sub-clause

9.1 Monitoring, Measurement, Analysis, and Evaluation

  • What methods are used for monitoring and measuring QMS performance, and are they effective?

  • How are quality objectives measured, and is there evidence of achievement?

  • What tools and processes are in place to analyze data and identify trends in performance?

9.1.2 Customer Satisfaction

  • How does the organization gather information on customer satisfaction and perceptions?

  • Are customer complaints and feedback used to inform improvements?

  • What methods are used to analyze customer satisfaction data, and how is it communicated to relevant personnel?

9.2 Internal Audit

  • Is there an internal audit plan that covers all relevant QMS processes?

  • How are internal auditors selected, and do they have the required competence and impartiality?

  • Are internal audit findings documented and addressed through corrective actions?

  • What follow-up actions are taken to ensure audit findings are effectively resolved?

9.3 Management Review

  • Are management reviews conducted at planned intervals, and do they cover all required inputs?

  • How are quality objectives, audit results, and customer satisfaction results reviewed?

  • What actions does management take based on review findings?

  • Is there evidence of continuous improvement initiatives stemming from management reviews?

Evidence to Collect

  1. Monitoring and Measurement Records:

    • Performance metrics, quality objectives monitoring records, trend analysis reports, and corrective action records tied to performance monitoring.

  2. Customer Satisfaction Data:

    • Customer feedback forms, survey results, complaint logs, customer satisfaction analysis reports, and records of actions taken based on customer feedback.

  3. Internal Audit Documentation:

    • Internal audit plans and schedules, auditor qualifications and training records, audit reports, records of nonconformities, and corrective action plans with follow-ups.

  4. Management Review Records:

    • Management review agendas, meeting minutes, records of input data (e.g., audit results, customer feedback, process performance), decisions made, and records of actions taken based on review outcomes.