Clause 9.1 of ISO 9001:2015 requires organizations to determine what needs to be monitored and measured, the methods to ensure valid results, when monitoring and measuring shall be performed, and when results shall be analyzed and evaluated. This is the “Check” phase of the PDCA cycle.
9.1.1: General
The organization must evaluate QMS performance and effectiveness and retain documented information as evidence of results.
9.1.2: Customer Satisfaction
Monitor customers’ perceptions of the degree to which their needs and expectations have been fulfilled. Determine the methods for obtaining, monitoring, and reviewing this information. This goes beyond complaint tracking — organizations must proactively gauge customer satisfaction through surveys, feedback forms, market data, compliments, warranty claims, and dealer reports.
9.1.3: Analysis and Evaluation
Analyze and evaluate appropriate data and information arising from monitoring and measurement. Results must be used to evaluate conformity of products and services, the degree of customer satisfaction, QMS performance and effectiveness, whether planning has been implemented effectively, the effectiveness of actions to address risks and opportunities, the performance of external providers, and the need for improvements to the QMS.
Best Practices
- Measure customer satisfaction through multiple methods (surveys, Net Promoter Score, complaint rates, repeat business)
- Track both leading and lagging quality indicators
- Use trend analysis and statistical methods to identify patterns
- Present data visually (dashboards, trend charts) for management review
- Ensure measurement methods are consistent to enable meaningful trend analysis
Common Pitfalls
- Relying solely on customer complaints as a measure of satisfaction
- Collecting data without analyzing it for trends and improvement opportunities
- Not using analysis results to drive decisions and improvements
- Measuring too many things without focus on what matters most
Related Ecesis Solutions
Document Management
Version-controlled procedures and records
Audits & Inspections
Schedule, conduct, and track audit findings
Nonconformity Tracking
Report, investigate, and resolve nonconformities
Training Management
Track competence requirements and records
Change Management
Structured review of planned changes
Compliance Obligations
Track requirements and evaluation schedules
