ISO 9001:2015 Chapter Structure

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Type: Structural Diagram
ISO 9001:2015 Chapter Structure

Diagram Content

Fragengruppen & Fragen

  1. Analysis and evaluation
    • Questions
      1. Is it assessed whether the planning has been implemented effectively?
      2. Is the need for improvements in the quality management system assessed?
      3. Is the level of customer satisfaction rated?
      4. Is the performance of external providers rated?
      5. Is the performance and effectiveness of the quality management system assessed?
      6. Is the effectiveness of measures implemented to deal with risks and opportunities evaluated?

ISO Chapters

  1. 9 - Performance evaluation
    • 9.1 - Monitoring, measurement, analysis and evaluation
      • Subchapters
        • 9.1.1.01 Has the organization determined what needs to be monitored and measured?
        • 9.1.1.02 Has the organization determined the methods for monitoring, measurement, analysis and valuation needed to ensure valid results?
        • 9.1.1.03 Has the organization determined when the monitoring and measuring shall be performed?
        • 9.1.1.04 Has the organization determined when the results from monitoring and measurement are analyzed and evaluated?
        • 9.1.1.05 Is the organization evaluating the performance and the effectiveness of the quality management system?
        • 9.1.1.06 Has the organization retained appropriate documented information as evidence of the results?
        • 9.1.2.01 Is the organization monitoring customers’ perceptions of the degree to which their needs and expectations are being fulfilled?
        • 9.1.2.02 Is the organization determining the methods for obtaining, monitoring and reviewing this information?
        • 9.1.3.01 Is the organization analyzing and evaluating appropriate data and information arising from monitoring and measurement?
        • 9.1.3.02 Has the organization used the results of the analysis to evaluate The conformity of products and services?
        • 9.1.3.03 Has the organization used the results of the analysis to evaluate the degree of customer satisfaction?
        • 9.1.3.04 Has the organization used the results of the analysis to evaluate the performance and effectiveness of the quality management system?
        • 9.1.3.05 Has the organization used the results of the analysis to evaluate if planning has been implemented effectively?
        • 9.1.3.06 Has the organization used the results of the analysis to evaluate the effectiveness of actions taken to address risks and opportunities?
        • 9.1.3.07 Has the organization used the results of the analysis to evaluate the performance of external providers?
        • 9.1.3.08 Has the organization used the results of the analysis to evaluate the need for improvements to the quality management system?
    • 9.2 - Internal audit
      • Subchapters
        • 9.2.01 Is the organization conducting internal audits at planned intervals to provide information on whether the quality management system:
          • 9.2.01a - conforms to the organization’s own requirements for its quality management system?
          • 9.2.01b - conforms to the requirements of the ISO 9001:2015 International Standard?
          • 9.2.01c - is effectively implemented and maintained?
        • 9.2.04 Has the organization planned, established, implemented and maintained an audit programme(s) including the frequency, methods, responsibilities, planning requirements and reporting which takes into consideration the importance of processes concerned, changes affecting the organization?
        • 9.2.05 Has the organization defined the audit criteria and scope for each audit?
        • 9.2.06 Has the organization selected auditors and conducted audits to ensure objectivity and impartiality of the audit process?
        • 9.2.07 Has the organization ensured that the results of audits are reported to relevant management?
        • 9.2.08 Has the organization taken appropriate correction and corrective actions without undue delay?
        • 9.2.09 Has the organization retained documented information as evidence of the implementation of the audit programme and the audit results?
    • 9.3 Management review
      • Subchapters
        • 9.3.1.01 Has top management reviewed the organization’s quality management system, at planned intervals, to ensure its continuing stability, adequacy, effectiveness and alignment with the strategic direction of the organization?
        • 9.3.2.01 Is the organization implemented management reviews.
        • 9.3.2.02 Has the organization taken into consideration the status of actions from previous management reviews?
        • 9.3.2.03 Has the organization taken into consideration changes in external and internal issues that are relevant to the quality management system?
        • 9.3.2.04 Has the organization taken into consideration information on the performance and effectiveness of the quality management system which includes trends in:
          • 9.3.2.04a - Customer satisfaction and feedback from relevant interested parties?
          • 9.3.2.04b - The extent to which quality objectives have been met?
          • 9.3.2.04c - Process performance and conformity of products and services?
          • 9.3.2.04d - Nonconformities and corrective actions?
          • 9.3.2.04e - Monitoring and measuring results?
          • 9.3.2.04f - Audit results?
          • 9.3.2.04g - The performance of external providers?
        • 9.3.2.11 Has the organization taken into consideration the adequacy of resources?
        • 9.3.2.12 Has the organization taken into consideration the effectiveness of actions taken to address risks and opportunities?
        • 9.3.2.13 Has the organization taken into consideration opportunities for improvement?
        • 9.3.3.01 Has the organization ensured that the outputs of the management review includes decisions and actions related to:
          • Opportunities for improvement?
          • Any need for changes to the quality management system?
          • Resource needs?
        • 9.3.3.04 Is the organization retaining documented information as evidence of the results of the management reviews?

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