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.
Subparagraphs of ISO 9001:2015 (a) to (g) 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.
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.
This requirement is comparable to ISO 9001:2008 Clause 8.4 - Analysis of Data. 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;
- Opportunities for preventive action;
- Suppliers and subcontractors.
- Need for corrective action;
- Opportunity for improvement;
The requirements of Clause 9.1.3 interrelate with those in clauses:
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.
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Monitoring, measurement, analysis and evaluation
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