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Requirements ISO 9001 version 2015

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Requirements ISO 9001 version 2015

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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Requirements ISO 9001 version 2015

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