9.0 Performance Evaluation

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9.1 Monitoring, Measurement, Analysis & Evaluation

9.1.3 Analysis & Evaluation

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, environmental and health & safety 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:

  1. Customer satisfaction and perception;
  2. Product conformance;
  3. Process performance;
  4. Product and process characteristics;
  5. Trends in products and processes;
  6. Opportunities for preventive action;
  7. Suppliers and subcontractors.
  8. Need for corrective action;
  9. Opportunity for improvement;
  10. Competition.

The requirements of Clause 9.1.3 interrelate with those in clauses:

  1. Management review input;
  2. Improvement;
  3. Corrective action;
  4. Risks and opportunities.

Furthermore, any record with data that is an established part of the EHQMS may be considered relevant for analysis. Records are evidence of system performance and should be analyzed for potential improvements.

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