Management system guidance
9.1 Monitoring, Measurement, Analysis and Evaluation
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9.1.3 Analysis and evaluation
What is analysis and evaluation?
This subclause requires businesses to analyse and evaluate data and information, obtained either internally about the QMS and its operational process, or externally about its suppliers.
Items a) to h) of clause 9.1.3 in ISO 9001:2026 provide a clear framework of what needs to be analysed and evaluated in order to demonstrate the conformity of products/services, ensure conformity of the quality management system, and continually improve its effectiveness. The results of your analysis must be used to evaluate:
- whether products and services conform;
- the level of customer satisfaction;
- how the quality management system is performing and how effective it is;
- whether planning has been implemented effectively;
- how effective the actions taken to address risks have been;
- how effective the actions taken to address opportunities have been;
- how external providers are performing;
- whether the quality management system needs to be improved.
What changed in ISO 9001:2026: in the 2015 edition a single item covered the effectiveness of actions taken to address risks and opportunities. ISO 9001:2026 splits this into e) risks and f) opportunities, reflecting the separate clauses 6.1.2 and 6.1.3, so the former f) and g) become g) and h). Your analysis should therefore show separately whether your risk actions and your opportunity actions have worked. Item d), the effectiveness of planning implementation, carries over from 2015. The standard notes that statistical techniques can be among the methods used to analyse data.
This requires knowing what should be analysed and evaluated and is specific to your operations, products, or services. An easy way to start is by simply asking:
- Why do I need to do data analysis, legal, contractual, policy?
- What do I need to measure in order to get the data for the data analysis?
- Why do I need this data?
- How will I measure and get that data?
- Who (or what) will measure and get/provide the data?
- When do I get this data? (How often)
- When do I communicate the data analysis?
- Who do I communicate the data analysis to?
Data is presented objectively so that well-informed decisions can be made. To facilitate transparency, full disclosure of assumptions, gaps, and exceptions must be documented wherever possible.
How do I collect data to analyse and evaluate?
Data collection systems exist to provide data to the function/department responsible for analyzing and reporting issues related to the effectiveness of the Quality Management System and overall quality improvement.
You should expect to see that the organization has developed a process (method, techniques, format, etc.) to identify, collect and analyze and evaluate data and information from both internal and external sources (i.e. quality records, monitoring and measuring results, process performance results, objectives, internal audit findings, customer surveys and feedback, 2nd or 3rd-party audit results, competitor and benchmarking information, product test results, complaints, supplier performance information, etc.).
This ‘input’ (information and data) should reflect upon the adequacy, suitability and effectiveness of the quality management system and its processes. The ‘output’ (result of the analysis) must provide information (understanding, insight, awareness, confidence, knowledge of, etc.). The analysis output must provide insight to:
- Customer satisfaction and perception;
- Product conformance;
- Process performance;
- Product and process characteristics;
- Trends in products and processes;
- Effectiveness of actions taken to address risks;
- Effectiveness of actions taken to address opportunities;
- External provider performance;
- Need for corrective action;
- Opportunity for improvement;
- Competition.
The requirements of Clause 9.1.3 interrelate with those in clauses:
- 9.3 Management review input;
- 10.1 Continual improvement;
- 10.2 Corrective action;
- 6.1 Risks and opportunities (6.1.2 risks; 6.1.3 opportunities).
Furthermore, any record with data that is an established part of the management system may be considered relevant for analysis. Records are evidence of system performance and should be analyzed for potential improvements. If you need a procedure and forms to help control your business's analysis and evaluation process, click here.
More information on PDCA
Planning
Context
Planning
Support
Doing
Support
Operations
Checking
Monitoring, measurement, analysis and evaluation
Acting
Improvement
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