ISO 9001: 2015 - Internal Audit Checklist for Purchase Process in Manufacturing
Master ISO 9001 supplier management and purchasing audits with this comprehensive tabular checklist. This guide provides practical audit questions covering supplier evaluation and selection, performance monitoring, purchase order requirements, supplier audits, nonconforming material handling, supply chain risk management, and purchasing competence. Quick reference format for efficient procurement and supplier management auditing.
📋 Quick Navigation
📝 Purchasing Process and Procedure (Clause 8.4.1)
Verify that a documented purchasing process exists defining how suppliers are selected, orders are placed, and materials are received. Check that the process is followed consistently.
| CLAUSE | AUDIT QUESTION | WHAT TO LOOK FOR |
|---|---|---|
| 8.4.1 | Is there a documented purchasing process/procedure? | Purchasing procedure documented, approval authority defined, supplier selection process clear, receiving process documented, roles and responsibilities assigned |
🔍 Supplier Evaluation and Selection (Clause 8.4.2)
Verify that new suppliers are evaluated before selection based on defined criteria. Check that evaluation considers quality capability, delivery performance, price competitiveness, and service.
| CLAUSE | AUDIT QUESTION | WHAT TO LOOK FOR |
|---|---|---|
| 8.4.2 | How are new suppliers evaluated before selection? (quality, delivery, price, service) | Supplier evaluation form or checklist, criteria defined (quality certification, references, financial stability), documented evaluation for recent suppliers, approval process before first order |
Evidence Check: Request evaluation records for 2-3 suppliers added in past 12 months. Verify all criteria were assessed before approval.
📊 Supplier Performance Monitoring (Clause 8.4.2)
Verify that supplier performance is actively monitored using defined metrics. Check that performance data is reviewed regularly and action is taken when performance declines.
| CLAUSE | AUDIT QUESTION | WHAT TO LOOK FOR |
|---|---|---|
| 8.4.2 | How is supplier performance monitored and reviewed? | Performance metrics defined (on-time delivery %, quality rejection rate, lead time), scorecards maintained, regular review meetings, performance trends tracked |
| 8.4.2 | What happens if a supplier's performance drops below acceptable levels? | Performance thresholds defined, corrective action requests issued, performance improvement plans required, potential removal from approved list, alternative suppliers identified |
| 8.4.2 | Can you show me supplier performance records? (on-time delivery, quality performance) | Supplier scorecards or dashboards, data tracked monthly or quarterly, historical trends available, all active suppliers evaluated, documentation systematic |
⚠️ Red Flag: If supplier performance data doesn't exist or isn't reviewed regularly, there's no control over supply chain quality.
🔎 Supplier Audits and Assessments (Clause 8.4.2)
Verify that critical suppliers are periodically audited or assessed. Check that audit findings are communicated and corrective actions are tracked.
| CLAUSE | AUDIT QUESTION | WHAT TO LOOK FOR |
|---|---|---|
| 8.4.2 | Are supplier audits or assessments conducted periodically? | Audit schedule for critical suppliers, on-site or remote audits conducted, audit reports documented, risk-based approach to audit frequency, third-party certifications accepted where appropriate |
📄 Purchase Order Requirements (Clause 8.4.3)
Verify that purchase orders clearly specify all requirements including part numbers, quantities, specifications, and delivery dates. Check that POs are controlled documents with proper authorization.
| CLAUSE | AUDIT QUESTION | WHAT TO LOOK FOR |
|---|---|---|
| 8.4.3 | Do purchase orders clearly specify what needs to be purchased? (part number, quantity, specifications) | Complete part descriptions, quantities clearly stated, delivery dates specified, unit prices included, supplier contact information correct, shipping address accurate |
| 7.5 | Are purchase orders controlled documents? (approved, updated, authorized) | Approval signatures required before release, revision control for PO changes, authorized personnel list maintained, PO numbering system used, records retained |
✅ Quality Requirements Communication (Clause 8.4.3)
Verify that quality requirements are clearly communicated to suppliers through purchase orders, including drawing references, material grades, tolerances, regulatory requirements, and inspection/testing needs.
| CLAUSE | AUDIT QUESTION | WHAT TO LOOK FOR |
|---|---|---|
| 8.4.3 | Are quality requirements clearly mentioned in purchase orders? (drawing reference, material grade, tolerance) | Drawing numbers referenced, revision levels specified, material specifications stated (grade, type), tolerance requirements included, quality standards referenced (ISO, ASTM, etc.) |
| 8.4.3 | Are statutory and regulatory requirements communicated to suppliers? (e.g., RoHS compliance, safety standards) | Regulatory compliance specified in PO, industry standards referenced, safety certifications required, conflict minerals declaration requested, environmental compliance noted |
| 8.4.3 | Are inspection and testing requirements communicated to suppliers? | Inspection requirements stated, test reports required, certificates of conformance requested, material certifications specified, witness inspection points defined |
| 8.2.2 | Is traceability requirement defined in PO if needed? (batch, heat number) | Traceability requirements specified for critical materials, batch/lot number documentation required, heat number traceability requested, serial number tracking mandated where applicable |
PO Review: Select 5 random recent purchase orders and verify all quality requirements are clearly stated and complete.
📦 Inventory Management (Clause 8.1 & 7.1.3)
Verify that adequate inventory levels are maintained to avoid production disruptions. Check that storage facilities are suitable for protecting incoming materials from damage or deterioration.
| CLAUSE | AUDIT QUESTION | WHAT TO LOOK FOR |
|---|---|---|
| 8.1 | Do you maintain adequate inventory levels to avoid stockouts? | Reorder points defined, safety stock calculated, inventory tracking system used, stockout history tracked, lead times considered in planning |
| 7.1.3 | Are storage facilities for incoming materials suitable? (clean, dry, organized) | Clean receiving and storage areas, temperature/humidity controlled where needed, organized racking or shelving, FIFO system implemented, materials protected from damage |
📈 Supplier Delivery and Quality Tracking (Clause 9.1.1)
Verify that supplier delivery performance and material quality are systematically tracked and measured. Check that metrics are used for supplier management decisions.
| CLAUSE | AUDIT QUESTION | WHAT TO LOOK FOR |
|---|---|---|
| 9.1.1 | How do you track supplier delivery performance? (on-time, late, early) | On-time delivery % calculated, late deliveries recorded with reasons, early deliveries tracked, data reviewed monthly or quarterly, trends analyzed |
| 9.1.1 | How do you measure quality of supplier materials? (defect rate, inspection failures) | Incoming inspection rejection rate calculated, defect types categorized, PPM (parts per million) tracked, quality issues documented with supplier, trend analysis conducted |
⚠️ Key Metric: Delivery and quality performance should be measured for ALL active suppliers, not just a few.
❌ Nonconforming Material Handling (Clause 10.2.1)
Verify that nonconforming materials from suppliers are properly handled and documented. Check that suppliers respond to corrective action requests and improvements are verified.
| CLAUSE | AUDIT QUESTION | WHAT TO LOOK FOR |
|---|---|---|
| 10.2.1 | When a supplier delivers nonconforming material, how is it handled? | Material quarantined immediately, nonconformity documented, supplier notified, disposition decided (return, use-as-is, rework), corrective action requested from supplier |
| 10.2.1 | Is supplier response to corrective action tracked and verified? | Supplier corrective action requests (SCAR) documented, supplier root cause analysis reviewed, corrective actions implemented and verified, effectiveness checked through subsequent deliveries |
Audit Check: Review recent nonconforming material reports. Verify supplier corrective actions were requested, received, and effectiveness verified.
👥 Purchasing Team Competence (Clause 7.2)
Verify that purchasing personnel are trained on procurement procedures, supplier management, quality requirements, and regulatory compliance. Check that training records are maintained.
| CLAUSE | AUDIT QUESTION | WHAT TO LOOK FOR |
|---|---|---|
| 7.2 | Are purchasing staff trained on procurement procedures and supplier management? | Training on purchasing procedures, supplier evaluation methods, negotiation skills, contract management, ERP/purchasing system training |
| 7.2 | Do purchase team members understand quality and regulatory requirements? | Training on product specifications, quality standards, regulatory compliance (RoHS, REACH, conflict minerals), industry-specific requirements, certification requirements |
| 7.2 | Are training records maintained for purchasing staff? | Training matrix for purchasing personnel, training dates documented, competence assessments conducted, refresher training scheduled, new employee orientation records |
Interview Check: Ask purchasing team members to explain supplier evaluation criteria and how they handle nonconforming materials. Verify understanding.
⚠️ Supply Chain Risk Management (Clause 6.1)
Verify that supply chain risks are identified and mitigated. Check that backup suppliers exist for critical materials and contingency plans are in place for supply disruptions.
| CLAUSE | AUDIT QUESTION | WHAT TO LOOK FOR |
|---|---|---|
| 6.1 | Are backup suppliers identified for critical materials? | Dual sourcing strategy for critical components, qualified alternate suppliers listed, relationships maintained with backup suppliers, periodic orders placed to maintain capability |
| 6.1 | What contingency plans exist if a key supplier fails to deliver? | Business continuity plans documented, emergency suppliers identified, expediting procedures defined, safety stock for critical items, communication protocols established |
📚 Supplier Information and Knowledge (Clause 7.4)
Verify that supplier-related information is gathered, maintained, and used for effective supplier management. Check that personnel are trained to understand and use this information.
| CLAUSE | AUDIT QUESTION | WHAT TO LOOK FOR |
|---|---|---|
| 7.4 | Is supplier information adequately gathered and maintained? | Supplier database or list maintained, key information fields defined (contact, capabilities, certifications), regular updates conducted, obsolete suppliers removed promptly |
| 7.4 | How is supplier information used in the organization? | Supplier information used in selection, performance evaluation, risk management, and communication, accessible to authorized personnel, protected from unauthorized access |
| 7.4 | Are personnel trained to understand and use supplier information? | Training on supplier management system, data entry and maintenance procedures, importance of accurate information, confidentiality and security requirements |
🌟 Audit Tips and Best Practices
Enhance your audit effectiveness with these best practices. Focus on key risk areas, ensure objective evidence is available, and verify the implementation and effectiveness of corrective actions.
| TIP # | BEST PRACTICE | DESCRIPTION |
|---|---|---|
| 1 | Focus on high-risk areas | Prioritize auditing of processes and suppliers that have historically shown nonconformities or are critical to product quality |
| 2 | Verify objective evidence | Ensure that all audit findings are backed by objective evidence such as documents, records, and direct observations |
| 3 | Check implementation of actions | For any previous audit findings, verify that effective corrective actions have been implemented and are sustainable |
| 4 | Engage with suppliers | Involve suppliers in the audit process where possible, to gain their insights and commitment to continuous improvement |
| 5 | Maintain audit trails | Keep clear and detailed audit trails for all findings, evidence, and communications, to support follow-up and verification activities |
