Perform ISO 9001:2015 Supplier Audit – Manufacturing using eAuditor
ISO 9001:2015 Supplier Audit – Manufacturing is a systematic process to assess a supplier’s quality management system (QMS) based on the ISO 9001:2015 standards. The audit evaluates the supplier’s processes, controls, and adherence to the required quality management practices. The goal is to ensure the supplier’s ability to consistently provide products or services that meet customer requirements and comply with relevant regulatory and industry standards. This audit typically focuses on areas such as quality control, document management, process performance, and continuous improvement, ensuring that suppliers align with the purchasing organization’s quality expectations and objectives.
Performing an ISO 9001:2015 Supplier Audit Checklist – Manufacturing using eAuditor ensures that suppliers comply with the quality management standards, ensuring the consistency and reliability of products and services. The inspection process helps in identifying areas of non-compliance, inefficiencies, or potential risks that could affect the supplier’s ability to meet the required standards. Here’s how to conduct the audit effectively using eAuditor:
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Pre-Audit Preparation
- Supplier Documentation Review: Review the supplier’s previous audits, quality management policies, and any relevant documents like certifications, quality objectives, and process flows.
- Checklist Customization: Customize the eAuditor template to include specific criteria aligned with ISO 9001:2015, including quality management system elements such as leadership, planning, support, operation, performance evaluation, and improvement.
- Audit Scope and Focus: Define the scope of the audit based on the supplier’s operations and your specific needs, focusing on critical areas like product quality, process control, or non-conformance handling.
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Conducting the Audit
- Quality Management System Evaluation:
- Assess the supplier’s adherence to their documented QMS. Ensure the company has a clear quality policy, quality objectives, and a documented process for continuous improvement.
- Verify that management reviews and internal audits are conducted regularly and documented as per ISO 9001:2015 standards.
- Leadership and Responsibility:
- Check if top management is actively involved in quality control and improvement processes.
- Ensure that roles, responsibilities, and authorities are well defined, communicated, and understood across all levels of the supplier’s organization.
- Risk Management and Mitigation:
- Evaluate how the supplier identifies, assesses, and mitigates risks in their processes. Ensure they have a process for addressing non-conformances and customer complaints.
- Process Control:
- Assess the supplier’s control over their manufacturing processes, ensuring they follow documented procedures and standards to maintain product quality.
- Inspect how they manage resources (e.g., personnel, equipment, materials) to ensure efficient and effective production.
- Performance Monitoring:
- Evaluate how the supplier monitors and measures product and process performance. This includes checking how they gather data, analyze trends, and take corrective actions when necessary.
- Customer Satisfaction:
- Investigate how the supplier collects and analyzes customer feedback to improve their products and services. Verify their customer complaint handling process.
- Continuous Improvement:
- Ensure the supplier follows the principle of continual improvement, implementing corrective actions, root cause analysis, and preventative measures.
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Documenting Findings and Non-Conformances
- Use eAuditor for Real-Time Reporting: During the audit, record findings using eAuditor’s mobile or tablet app. Capture observations and any evidence, such as photographs or notes, to substantiate non-conformities.
- Identify Non-Conformities: Highlight any non-conformities or areas where the supplier is not meeting the required ISO 9001:2015 standards. For each non-conformance, assign corrective actions and deadlines.
- Compliance Assessment: For each checklist item, mark whether the supplier is compliant, partially compliant, or non-compliant. Add comments and supporting evidence.
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Post-Audit Actions
- Generate Reports: After completing the audit, eAuditor generates a comprehensive report summarizing the audit findings, including non-conformities, compliance status, and recommended corrective actions.
- Share Reports: The audit report is instantly shareable with relevant stakeholders or the supplier’s management team for transparency and follow-up.
- Corrective Action and Follow-up: Based on the audit findings, provide the supplier with corrective action recommendations and track their implementation. Schedule follow-up audits if necessary to ensure compliance is achieved.
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Continuous Monitoring and Improvement
- Supplier Evaluation: Regularly assess the supplier’s performance through ongoing audits, ensuring that any improvements or corrective actions are effectively implemented and maintained.
- Review and Improve Audit Processes: Review the audit process to ensure it remains aligned with ISO 9001:2015 and continuously improves over time.
Summary
Performing an ISO 9001:2015 Supplier Audit – Manufacturing using eAuditor helps ensure that the supplier meets the required quality standards and consistently delivers products that align with customer expectations. eAuditor’s mobile platform streamlines the audit process, enabling efficient data capture, real-time reporting, and easy tracking of corrective actions, ultimately improving the supplier’s compliance and product quality.