# ISO 9001 Audit Question Bank Open questions ("show me", "how do you") with the evidence to sample. `scripts/checklist.py` reads this file: keep the `### ` headings and the `- <question> | <evidence>` lines. ### 4.1 Context - How do you identify the internal and external issues that affect your results, and when were they last reviewed? | Issue register, review date, MR minutes - Have you decided whether climate change is a relevant issue? Show the decision. | Context record (Amd 1:2024) ### 4.2 Interested parties - Who are the relevant interested parties and which of their requirements have you adopted? | Interested-party register - How do changes in their requirements reach the processes? | Example of a requirement traced to a procedure ### 4.3 Scope - Show me the scope statement. Does it cover all products, services and sites? | Scope document vs site walk - What requirements did you determine as not applicable, and why does that not affect conformity? | Justification ### 4.4 Processes - Show me how your processes interact. Who owns each one and how is its performance measured? | Process map, KPIs - Pick one process: what are its inputs, outputs, criteria and risks? | Turtle diagram or process description ### 5.1 Leadership - (Top management) What are your quality objectives and how are you doing against them? | Interview, KPI board - How do you make sure the QMS has the resources it needs? Give a recent example. | MR decisions, budget approvals ### 5.2 Policy - Where is the quality policy, and what does it mean for your job? | Posted policy; staff interviews ### 5.3 Roles - Who reports QMS performance to top management? Who can stop production or release product? | Authority matrix, job descriptions ### 6.1 Risks and opportunities - Show me the risks and opportunities for this process and the actions taken. | Risk register, action status - How did you check whether those actions worked? | Effectiveness review ### 6.2 Objectives - What objectives apply to this process, what is the target, and who owns the plan? | Objectives register - Show me the latest results and what you are doing about any gap. | Trend chart, action plan ### 6.3 Planning of changes - Tell me about a recent change to the QMS or organization. How was it planned? | Change plan, risk review ### 7.1.3 Infrastructure - How is this equipment maintained? Show me its maintenance plan and last record. | PM schedule, work orders ### 7.1.5 Measuring resources - Pick three gauges in use: are they identified, in calibration and traceable? | Labels, calibration register, certificates - What happened the last time a gauge failed calibration? | Out-of-tolerance impact assessment ### 7.1.6 Knowledge - What knowledge does this process depend on, and what happens if a key person leaves? | Lessons learned, cross-training matrix ### 7.2 Competence - What competence does this job need, and how do you know this person has it? | Competence matrix, training records - How did you check that the last training was effective? | Effectiveness evaluation ### 7.3 Awareness - (Operator) What happens if your work is not right? Which objectives affect your area? | Interview ### 7.4 Communication - How do customer complaints or drawing changes reach this area? | Communication matrix, example ### 7.5 Documented information - Show me the instruction you are using. Is it the current revision? | Point-of-use copy vs register - How long are these records kept and how are they protected? | Retention schedule, storage ### 8.1 Operational planning - How is this order planned: routing, resources, inspection points, records? | Router/traveller, control plan - Which processes are outsourced and how are they controlled? | Outsourced process list, controls ### 8.2 Customer requirements - Show me the review of this order before acceptance. Who reviewed and what was checked? | Contract review record - How are customer complaints recorded and answered? | Complaint log, example ### 8.3 Design and development - Show me the design plan for a recent project, its reviews, verification and validation. | Design file - How are design changes reviewed and approved? | Change records ### 8.4 External providers - How was this supplier selected and when was it last evaluated? | ASL entry, evaluation, scorecard - Show me a purchase order: does it state the drawing revision, quality requirements and verification? | PO - How do you verify purchased product on receipt? | Receiving inspection record ### 8.5.1 Production control - Show me how you know this job is set up right before running it. | First-off approval, setup sheet - Which processes cannot be fully verified afterwards, and how were they validated? | Special process validation - What error-proofing protects against the most likely mistakes here? | Poka-yoke list, verification ### 8.5.2 Traceability - Trace this part back to its material certificate and forward to the customer shipment. | Traveller, lot numbers, CoC ### 8.5.4 Preservation - How is this product protected during handling, storage and shipping? | Packaging spec, storage conditions ### 8.5.6 Control of changes - Tell me about the last process change here. Who reviewed and approved it? | Change request, approval ### 8.6 Release - Who released this shipment and what evidence shows it met all requirements? | Final inspection record, signature ### 8.7 Nonconforming outputs - Where are nonconforming parts held, and who decides their disposition? | Quarantine area, NCR, authority - Show me a use-as-is or repair disposition. Was a concession obtained? | Concession record ### 9.1 Monitoring and measurement - What does this process measure and what did the last analysis show? | KPI chart, analysis - How do you know what customers think of you? | Satisfaction data, scorecards ### 9.2 Internal audit - Show me the audit programme. Was every process audited, and by independent auditors? | Programme, reports - Pick a finding: how was it closed? | CAPA record ### 9.3 Management review - Show me the last management review. Were all required inputs covered and what was decided? | Minutes, actions ### 10.2 Corrective action - Pick a recent nonconformity: what was the root cause, the action and the effectiveness check? | CAPA record - Did you check whether similar nonconformities exist elsewhere? | CAPA scope review ### 10.3 Continual improvement - What has improved in this process in the last year, and how do you know? | Trend data, project results