Management system guidance
9.1 Monitoring, Measurement, Analysis and Evaluation
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9.1.1 Monitoring, measurement, analysis and evaluation - general
Clause 9.1.1 requires your organization to determine what needs to be monitored and measured, the methods for monitoring, measurement, analysis and evaluation that will give valid results, when monitoring and measuring will be carried out, and when the results will be analysed and evaluated. You should look for evidence that the results are evaluated, not just analysed, and that decisions based on them are ensuring appropriate process control.
If relevant issues related to climate change have been determined by your organization, these may have specific monitoring and measurement needs, eventual implications on monitoring and measuring customer satisfaction or changes to the audit programme.
Your organization must also evaluate the performance and effectiveness of its quality management system. You should expect to see that your organization has developed a process (method, techniques, format, etc.) to identify, collect and analyze various data and information from both internal and external sources, including:
- Monitoring and measuring results;
- Process performance results;
- Meeting objectives;
- Internal audit findings;
- Customer surveys and feedback;
- 2nd or 3rd party audit results;
- Competitor and benchmarking information;
- Product test results;
- Supplier performance information.
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 and opportunities;
- Performance of external providers.
Other potential or useful options might include:
- Need for corrective action;
- Opportunity for improvement;
- Competition.
Documented information must be available as evidence of the results of monitoring, measurement, analysis and evaluation. The quality objectives and the related KPIs established under Clause 6.2 provide useful input into addressing this clause.
Monitoring and measuring QMS operations and activities will establish a mechanism to ensure that your organization is meeting its quality policy and objectives. A practical way to meet this requirement is to follow six steps:
- Identify the processes and activities that have a significant effect on product and service conformity, customer satisfaction or risk;
- Determine key characteristics of the activity to be monitored;
- Select the best way to measure the key characteristics;
- Record data on performance, controls and conformance with objectives;
- Determine the frequency with which to measure the key characteristics;
- Establish management review and reporting.
Establish the monitoring and tracking criteria for each activity that has a significant effect on quality or carries significant risk and review the action plan. You should incorporate any monitoring and measurement information to cover these same activities. If you need a procedure and forms to help control your business's testing and inspection 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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