ISO 9001:2015 - Performance Evaluation
Clause 9 of ISO 9001:2015 focuses on evaluating the performance of the quality management system through monitoring, measurement, analysis, and evaluation. This includes customer satisfaction, internal audits, and management review.
9.1 Monitoring, Measurement, Analysis and Evaluation
| Element |
Requirements |
Methods |
| What to Monitor |
Process performance |
KPIs, metrics |
| Methods |
Valid results |
Statistical techniques |
| When to Monitor |
Timing of analysis |
Monitoring schedule |
| When to Analyze |
Data evaluation |
Analysis procedures |
| Evidence |
Results documentation |
Performance records |
Customer Satisfaction
| Method |
Data Source |
Analysis Approach |
| Surveys |
Direct feedback |
Trend analysis |
| Reviews |
Customer comments |
Content analysis |
| Complaints |
Issue reports |
Root cause analysis |
| Market Share |
Sales data |
Comparative analysis |
| Warranties |
Claim records |
Pattern analysis |
9.2 Internal Audit
Audit Program
| Element |
Requirements |
| Frequency |
Risk-based scheduling |
| Methods |
Audit techniques |
| Planning |
Resource allocation |
| Selection |
Auditor qualification |
| Reporting |
Results communication |
Audit Process
| Stage |
Activities |
| Planning |
Scope definition, checklist preparation |
| Execution |
Evidence collection, interviews |
| Reporting |
Findings documentation |
| Follow-up |
Corrective action verification |
9.3 Management Review
| Review Element |
Inputs |
Outputs |
| Status of Actions |
Previous review actions |
Improvement opportunities |
| Changes |
Internal/external issues |
Change requirements |
| Performance |
Monitoring results |
Resource needs |
| Effectiveness |
Audit results |
System modifications |
| Resources |
Resource adequacy |
Action plans |
Performance Indicators
Process Metrics
| Category |
Indicators |
| Quality |
Defect rates, complaints |
| Efficiency |
Cycle time, waste |
| Effectiveness |
Goal achievement |
| Compliance |
Audit findings |
Analysis Methods
| Method |
Application |
| Trend Analysis |
Performance patterns |
| Statistical Analysis |
Data relationships |
| Root Cause Analysis |
Problem investigation |
| Comparative Analysis |
Benchmarking |
Best Practices
- Establish clear performance metrics
- Use appropriate statistical methods
- Maintain documented evidence
- Ensure auditor independence
- Follow up on audit findings
- Document management reviews
- Track improvement actions
- Analyze trends systematically
- Monitor customer feedback
- Review resource adequacy