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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
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Evaluate Monitoring and Measurement: Ensure processes are in place to monitor and measure QMS performance, including product and service conformity.
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Review Customer Satisfaction Efforts: Verify that customer satisfaction is monitored and analyzed for continuous improvement.
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Assess Internal Audit Processes: Confirm that internal audits are planned, implemented, and documented to assess QMS effectiveness.
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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
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What methods are used for monitoring and measuring QMS performance, and are they effective?
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How are quality objectives measured, and is there evidence of achievement?
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What tools and processes are in place to analyze data and identify trends in performance?
9.1.2 Customer Satisfaction
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How does the organization gather information on customer satisfaction and perceptions?
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Are customer complaints and feedback used to inform improvements?
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What methods are used to analyze customer satisfaction data, and how is it communicated to relevant personnel?
9.2 Internal Audit
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Is there an internal audit plan that covers all relevant QMS processes?
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How are internal auditors selected, and do they have the required competence and impartiality?
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Are internal audit findings documented and addressed through corrective actions?
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What follow-up actions are taken to ensure audit findings are effectively resolved?
9.3 Management Review
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Are management reviews conducted at planned intervals, and do they cover all required inputs?
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How are quality objectives, audit results, and customer satisfaction results reviewed?
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What actions does management take based on review findings?
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Is there evidence of continuous improvement initiatives stemming from management reviews?
Evidence to Collect
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Monitoring and Measurement Records:
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Performance metrics, quality objectives monitoring records, trend analysis reports, and corrective action records tied to performance monitoring.
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Customer Satisfaction Data:
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Customer feedback forms, survey results, complaint logs, customer satisfaction analysis reports, and records of actions taken based on customer feedback.
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Internal Audit Documentation:
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Internal audit plans and schedules, auditor qualifications and training records, audit reports, records of nonconformities, and corrective action plans with follow-ups.
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Management Review Records:
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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.