Contributor: Safesite
This inspection gives a complete analysis of your organization's alignment with ISO 9001 standards. This portion covers competence, awareness, communication, documentation and operational planning and control.
1. Competence: Show me how you determine the necessary competence of people doing work under your control that affects quality performance.
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2. Competence: Show me how you determine competence on the basis of appropriate education, training or experience
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3. Competence: Show me how you take actions to acquire necessary competence where applicable and how do you evaluate the effectiveness of those actions.
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4. Competence: Verify documented information as evidence of competence where appropriate.
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5. Awareness: Verify people doing work under the organization's control are aware ofthe quality policy.
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6. Awareness: Verify people doing work under the organization's control are aware of the relevant quality objectives.
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7. Awareness: Verify people doing work under the organization's control are aware of their contribution to the effectiveness of the QMS, including the benefits of improved performance.
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8. Awareness: Verify people doing work under the organization's control are aware of the implications of not conforming with the QMS requirements.
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9. Communication: Verify internal and external communication process (what, when, with whom and how to communicate).
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10. Documented information: Verify documented information required by the ISO 9001:2015 standard.
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11. Documented information: Verify documented information that shows the effectiveness of the QMS.
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12. Documented information: Show me that your documented information contains appropriate identification, format (language, software version, graphics, ...) and media (paper, electronic, ...).
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13. Documented information: Show me how the documented information is reviewed and approved for suitability and adequacy.
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14. Documented information: Show me how you control documented information and make it available and suitable for use. Tell me how you protect your documented information.
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15. Documented information: Verify how the organization controls the distribution, access, retrieval, use, storage, preservation, legibility, control of changes, retention and disposition of documented information.
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16. Documented information: Verify documented information of external origin is identified, as appropriate, and controlled.
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17. Operational planning and control: Verify how the organization has planned, implemented and controlled processes needed to meet the requirements of products and services.
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18. Operational planning and control: Verify how requirements for products and services are determined.
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19. Operational planning and control: Verify how criteria for processes and acceptance for products and services are determined.
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20. Operational planning and control: Verify how resources are determined.
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21. Operational planning and control: Verify how process control is implemented.
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22. Operational planning and control: Show me documented information that demonstrates processes have been carried out as planned and can demonstrate conformity of products and services.
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23. Operational planning and control: Determine how output from the planning process is suitable for operations.
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24. Operational planning and control: Verify how planned changes are controlled. Verify how unintended changes are reviewed and what actions are taken to mitigate any adverse effects, as necessary.
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25. Operational planning and control: Verify how outsourced processes are controlled.
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26. Determination of requirements for products and services: Verify processes created for communicating with customers on information relating to products, services, enquiries, contracts, order handling, customer views, perceptions and complaints, handling or treatment of customer property and specific requirements for contingency actions.
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27. Determination of requirements for products and services: Verify process to determine the requirements for products and services to be offered to potential customers and how the process is established, implemented and maintained.
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28. Determination of requirements for products and services: customer requirements for delivery and post-delivery.
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29. Determination of requirements for products and services: Verify how the organization reviews..
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