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Records required for a world-class quality system

Posted by on in ISO Quality Standards

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Do you have a quality focus with an eye on an export market? Here’s a list of records required by a quality standard such as ISO 9001: 

  1. Management review minutes 
  2. Education, training, skills and experience 
  3. Evidence that the realization processes and resulting product fulfil requirements 
  4. Results of the review of requirements relating to the product and actions arising from the review 
  5. Design and development inputs 
  6. Results of design and development reviews and any necessary actions 
  7. Design and development inputs 
  8. Results of design and development reviews and any necessary actions 
  9. Results of design and development verification and any necessary actions 
  10. Results of design and development validation and any necessary actions 
  11. Results of the review of design and development changes and any necessary actions 
  12. Results of supplier evaluations and actions arising from the evaluations 
  13. As required by the company to demonstrate the validation of processes where the resulting output cannot be verified by subsequent monitoring or measurement 
  14. The unique identification of the product, where traceability is a requirement 
  15. Customer property that is lost, damaged or otherwise found to be unsuitable for use 
  16. Standards used for calibration or verification of measuring equipment where no international or national measurement standards exist 
  17. Validity of previous results when measuring equipment is found not to conform with its requirements 
  18. Results of calibration and verification of measuring equipment 
  19. Internal audit results 
  20. Evidence of product conformity with the acceptance criteria and indication of the authority responsible for the release of the product 
  21. Nature of the product nonconformities and any subsequent actions taken, including concessions obtained 
  22. Results of corrective actions 
  23. Results of preventive actions
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