Internal Audit Questions - Process
<Short Name> ISO 9001:2015
Process Definition Questions
• Is the process defined and documented?
• Is the process owner identified? (Process map, procedure or work instruction, etc.)
• Is there evidence that process inputs are accurately defined and understood by all staff
involved?
• Is there evidence that process activities are accurately defined and understood by all staff
involved?
• Is there evidence that process outputs are accurately defined and understood by all staff
involved?
• Are inputs defined and prioritized based on risk?
• Have procedures, instructions, and forms been established as needed to control the
process?
• Are procedures, instructions and forms used in controlling the process readily available?
• Do procedures, instructions and forms accurately reflect the practices?
• Are there adequate plans in place to achieve the objectives?
• Is relevant customer feedback available? (Feedback from subsequent processes)
• Are documents understood by process operatives?
Process Resource Questions
• Is there evidence of management commitment, involvement and allocation of resources?
• How many people participate in the process, is this adequate to achieve process
requirements?
• Are operatives adequately trained to carry out roles, responsibilities, and authorities?
• Is equipment (e.g. manufacturing, measuring & monitoring equipment;
transport/logistics; hardware/software; PPE; etc.) fit for purpose?
• Is equipment identified to allow operatives to determine its readiness for safe use prior
to and during the operation?
• Are process owners accountable for the performance and compliance of their processes?
• Are staff satisfied with their work area?
• Is the work area clean and safe?
• Is there adequate equipment/tools/IT support?
• Are staff motivated and encouraged to make suggestions for process improvement?
• Are all staff aware of the organizational objectives and the current status of these
measurements?
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Internal Audit Questions - Process
<Short Name> ISO 9001:2015
• Are all staff aware of who their customers are and whether they are satisfied?
• Are staff aware of the process metrics which their activities can affect?
• Are they aware of the current data analysis related to these metrics and the plans in place
to achieve them?
Process Execution Questions
• Is the observed process activity consistent with documented plans and procedures?
• Are redundant and non-value adding activities minimized?
• Is waste material effectively removed and segregated from the process?
• Are unused materials returned to the correct location in conditions suitable to allow re-
use?
• Are process outputs passed on to subsequent processes only when all planned process
activities are completed?
• Is there evidence of continuity between the various support processes?
• Do the interfaces between the departments operate smoothly?
• Does product information flow freely between the support processes?
• Is there evidence for the reduction in measurement system and process variation?
Process Monitoring Questions
• Is the process monitored, measured, analyzed and improved?
• Are monitoring activities carried out according to approved plans and procedures?
• Is process monitoring compared against standards to determine the current status of the
process?
• Is process status communicated to appropriate members of the process team?
• Are records of process monitoring maintained according to approved procedures?
• Have key performance indicators (KPIs) been established to allow the effectiveness of the
process to be evaluated?
• Are KPIs consistent with quality and business objectives?
• Are KPIs consistent with customer requirements?
• Are KPIs reviewed and communicated to the process team, as appropriate, by process
leaders?
• Is the process measured for effectiveness and efficiency?
• When a process is not performing, is there evidence of data analysis to determine the root
cause?
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Internal Audit Questions - Process
<Short Name> ISO 9001:2015
• When a process is not performing, is there evidence that the cause(s) are dealt with in
accordance with procedure?
• Are records of process monitoring reviewed regularly to determine opportunities for
corrective and preventive action?
Process Improvement Questions
• Is the performance of the process reviewed at an appropriate frequency by top
management?
• Are process improvement objectives aligned with organizational objectives, e.g. the
business plan?
• Is there evidence of an effective PDCA cycle?
• Can the process owner demonstrate how PDCA applies to their process?
• Can the process owner to show examples of improvements driven by their PDCA cycle?
• Can staff demonstrate areas of previous continual improvement?
• Are records of process upsets and actions taken reviewed to determine the need for
corrective/preventive action?
• Where corrective/preventive actions have been implemented, have the action(s) taken
been demonstrated as effective?
• Where opportunities for improvement have been implemented, have the action(s) taken
been demonstrated as effective?
• Are all process operatives encouraged to be involved in identifying improvements?
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