IATF 16949:2016 Stage 1 Audit Checklist
1. Context of the Organization
• Q: Have you identified internal and external issues relevant to your QMS?
A: Yes, through SWOT and PESTLE analysis, covering risks/opportunities.
Evidence: SWOT/PESTLE reports, management review minutes.
• Q: Who are your interested parties and their needs?
A: Customers, employees, suppliers, regulators identified with documented requirements.
Evidence: Interested parties list, stakeholder matrix.
• Q: Have you defined the scope of your QMS?
A: Yes, scope statement includes products, processes, sites, and exclusions.
Evidence: Quality manual, scope document.
2. Leadership
• Q: How is top management demonstrating leadership for the QMS?
A: They chair management reviews, set policies, and allocate resources.
Evidence: Management review agenda, signed quality policy.
• Q: Is the quality policy communicated and understood?
A: Yes, displayed across the site and communicated during onboarding.
Evidence: Training records, site postings.
• Q: Are quality objectives aligned with strategic direction?
A: Yes, objectives are measurable and cascaded to departments.
Evidence: Quality objectives dashboard, departmental KPIs.
3. Planning
• Q: Have risks and opportunities been identified?
A: Yes, maintained in a risk register linked with FMEA.
Evidence: Risk register, FMEA reports.
• Q: How are quality objectives planned and tracked?
A: Objectives have targets, owners, and monitoring schedules.
Evidence: Objective plan, scorecards.
• Q: Do you have a documented change management process?
A: Yes, with risk assessment and approval steps.
Evidence: Engineering change forms, change logs.
4. Support
• Q: How is competence ensured?
A: Through training needs analysis, competency matrix, and annual reviews.
Evidence: Training records, competency matrix.
• Q: How do you ensure awareness of QMS roles?
A: Job descriptions and toolbox meetings clarify roles.
Evidence: Job descriptions, induction materials.
• Q: How is communication handled internally and externally?
A: Communication plan covers meetings, dashboards, and customer portals.
Evidence: Meeting records, emails, noticeboards.
• Q: How do you control documented information?
A: Via document control procedure with revision and approval control.
Evidence: Documented procedure, master list.
5. Operation
• Q: How are customer requirements determined?
A: Reviewed at contract review and translated into control plans.
Evidence: Contract review forms, APQP records.
• Q: How do you manage design and development?
A: APQP process with feasibility review, DFMEA, and validation.
Evidence: DFMEA, validation test reports.
• Q: How are outsourced processes controlled?
A: Approved supplier list, audits, and PPAP requirements.
Evidence: Supplier audits, PPAP submissions.
• Q: How do you plan production and service provision?
A: Controlled via process flow, PFMEA, and control plans.
Evidence: Control plan, process sheets.
6. Performance Evaluation
• Q: How do you monitor customer satisfaction?
A: Using scorecards, surveys, and complaint analysis.
Evidence: Customer scorecards, complaint log.
• Q: How is process performance evaluated?
A: Monitored via KPIs (OEE, scrap, delivery).
Evidence: KPI dashboards, monthly reports.
• Q: How is internal audit conducted?
A: Per annual audit plan, trained auditors, and corrective actions tracked.
Evidence: Audit plan, audit reports.
• Q: How often is management review conducted?
A: At least once per year, covering KPIs, risks, and customer feedback.
Evidence: Management review minutes.
7. Improvement
• Q: How are nonconformities handled?
A: Through 8D methodology and root cause analysis.
Evidence: 8D reports, corrective action logs.
• Q: How are corrective actions tracked for effectiveness?
A: Verified via follow-up audits and KPI improvements.
Evidence: CA logs, follow-up reports.
• Q: Do you have continual improvement activities?
A: Yes, using Kaizen events, Six Sigma, and lean projects.
Evidence: Kaizen logs, project reports.
