Quiz requirements ISO 9001 version 2015

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1. A design and development process shall be established, implemented and maintained

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2. A documented information to control external processes shall be maintained

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3. A member of the management shall be appointed as management representative

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4. A register to determine the risks when selecting suppliers shall be maintained

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5. A review of product and service requirements shall be conducted

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6. A risk management process shall be established

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7. Actions to address risks and opportunities shall be planned

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8. Changes for production or service provision shall be reviewed and controlled

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9. Changes shall be planned

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10. Control of monitoring and measuring equipment shall be determined

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11. Criteria for the evaluation, selection and monitoring of performance of external providers shall be determined and applied

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12. Customer perception of the degree to which their needs shall be monitored

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13. Design and development changes shall be controlled

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14. Design and development shall be planned

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15. Documents of external origin shall be approved

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16. External and internal issues shall be determined

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17. Externally provided processes, products and services shall be controlled

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18. Information communicated to external providers shall be adequate

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19. Infrastructure needed to achieve product conformity shall be monitored

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20. Interested parties shall be determined

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21. Internal and external communication needs shall be determined

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22. Internal audits shall be conducted at planned intervals

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23. Measuring equipment shall be calibrated or verified

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24. Monitoring and measurement data shall be analyzed and evaluated

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25. Nonconforming outputs shall be identified and controlled

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26. Nonconformities shall be controlled

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27. Opportunities for improvement shall be determined

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28. Organizational knowledge shall be determined

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29. Outputs shall be preserved during production and service provision

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30. Personnel shall be made aware

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31. Planned arrangements to verify that the product and service requirements have been met shall be implemented

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32. Post-delivery requirements shall be met

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33. Process mapping shall be established and documented

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34. Production and service provision shall be implemented under controlled conditions

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35. Property belonging to customers or external providers shall be respected

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36. Quality objectives shall be established

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37. Requirements for products and services shall be defined

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38. Resources needed for monitoring and measurement shall be provided

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39. Resources needed for the management of the QMS shall be provided

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40. The audit program shall be planned, implemented and maintained

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41. The design and development process shall be controlled

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42. The necessary competence of personnel shall be determined

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43. The necessary documented information shall be controlled

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44. The necessary process environment shall be provided

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45. The necessary process infrastructure shall be provided

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46. The necessary processes shall be planned and controlled

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47. The performance and the effectiveness of the QMS shall be evaluated

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48. The processes needed for the QMS shall be determined

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49. The quality manual shall be established and maintained

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50. The quality policy shall be available, communicated, understood and applied

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51. The risks and opportunities that need to be addressed shall be determined

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52. The scope of the QMS shall be determined

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53. The suitability, adequacy and effectiveness of the QMS shall be continually improved

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54. The unique identification of the outputs shall be controlled when traceability is a requirement

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55. Top management shall demonstrate leadership

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56. Top management shall demonstrate leadership and commitment with respect to customer focus

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57. Top management shall ensure that the responsibilities and authorities are assigned, understood and implemented

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58. Top management shall manage the quality policy

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59. Top management shall review the QMS

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60. Top management shall take accountability for the effectiveness of the QMS

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Quiz requirements ISO 9001 version 2015