ISO Compliance Audit: Purchasing Department
Budget: $250 – $750 USD
For external ISO audit of the Purchasing Department need to prepare a set of documents and evidence to demonstrate compliance with the relevant ISO standards. Specifically, ISO 9001:2015, Section 8.4 (Control of Externally Provided Processes, Products, and Services), and ISO 22000:2018, Section 8.5.1.2 (Characteristics of Raw Materials, Ingredients, and Product Contact Materials), require that purchasing activities are adequately controlled to ensure that externally provided goods and services meet quality and safety requirements.
Specific Documents and Evidence to Prepare:
1. Supplier Evaluation and Selection Procedures:
• Supplier assessment criteria.
• Supplier approval/rejection records.
• Documentation showing periodic review of supplier performance.
2. Purchasing Records:
• Purchase orders, contracts and agreements with suppliers.
• Incoming material inspection records (e.g., checklists, sample inspection results).
• Certificates of conformity or analysis from suppliers.
3. Audit Reports:
• Records of supplier audits or visits (internal and external).
• Corrective and preventive action records related to supplier issues.
4. Non-Conforming Product Records:
• Non-conformance reports (NCRs) for purchased products or services.
• Corrective action plans and outcomes.
5. Supplier Certificates and Documentation:
• Certifications or declarations from suppliers (e.g., ISO 9001, ISO 22000, HACCP).
• Records of compliance with product safety and regulatory requirements (e.g., food safety certifications for raw materials).
6. Risk Management Documents:
• Risk assessments related to suppliers, raw materials or outsourced activities.
• Mitigation plans for high-risk suppliers or materials.
7. Product Traceability Records:
• Records of product traceability for raw materials (e.g., batch numbers, lot traceability).
Specific Documents and Evidence to Prepare:
1. Supplier Evaluation and Selection Procedures:
• Supplier assessment criteria.
• Supplier approval/rejection records.
• Documentation showing periodic review of supplier performance.
2. Purchasing Records:
• Purchase orders, contracts and agreements with suppliers.
• Incoming material inspection records (e.g., checklists, sample inspection results).
• Certificates of conformity or analysis from suppliers.
3. Audit Reports:
• Records of supplier audits or visits (internal and external).
• Corrective and preventive action records related to supplier issues.
4. Non-Conforming Product Records:
• Non-conformance reports (NCRs) for purchased products or services.
• Corrective action plans and outcomes.
5. Supplier Certificates and Documentation:
• Certifications or declarations from suppliers (e.g., ISO 9001, ISO 22000, HACCP).
• Records of compliance with product safety and regulatory requirements (e.g., food safety certifications for raw materials).
6. Risk Management Documents:
• Risk assessments related to suppliers, raw materials or outsourced activities.
• Mitigation plans for high-risk suppliers or materials.
7. Product Traceability Records:
• Records of product traceability for raw materials (e.g., batch numbers, lot traceability).