Rather than auditing isolated clauses or departments, process-based audits evaluate how work flows across the organization, from inputs to outputs. This method aligns with ISO 9001:2015's process approach and is critical for ensuring both compliance and continuous improvement. In today's blog post, we'll break down everything you need to know to plan and execute a successful process-based internal audit, including the use of an internal audit checklist and ISO 9001 audit checklist. What is a Process-Based Internal Quality Audit? A process-based audit focuses on the actual processes that deliver value to the customer. It examines how those processes are planned, controlled, and improved—and whether they meet the intended outcomes. This approach is crucial for ISO 9001 internal audits and the ISO 9001 certification process. Step-by-Step: How to Perform a Process-Based Internal Quality Audit 1. Understand the Purpose and Benefits Start by establishing a clear understanding of why you're conducting the audit. This helps set expectations and gain management buy-in, which is crucial for leadership commitment in the ISO 9001 certification process. 2. Select and Define the Process to Audit Ensure your audit selection is strategic and risk-based by focusing on high-impact processes, areas with recent changes, or those with past nonconformities. 3. Study Documented Information and Process Inputs Understand what the process is supposed to achieve, how it is measured, and where it interfaces with other processes. This step is crucial for operational planning and process control. 4. Prepare a Process-Focused Internal Audit Checklist Your internal audit checklist should be tailored to the specific process. Avoid rigid clause-by-clause checklists. Instead, create an ISO 9001 audit checklist that focuses on process effectiveness. 5. Conduct the Audit With preparation complete, it's time to audit. Focus on how the process actually works in real time, using your ISO 9001 audit checklist as a guide. 6. Identify Findings and Evaluate Process Performance Audit findings should go beyond basic compliance by identifying conformities, nonconformities, and opportunities for improvement to drive continual improvement efforts and strengthen the overall quality management system. 7. Compile and Communicate the Audit Report Your audit report should be clear, concise, and actionable. It's a crucial piece of documented information in the ISO 9001 certification process. 8. Ensure Follow-Up on Corrective Actions Use a corrective action tracking system or QMS software, like Accupoint Software, to monitor closure. This step is crucial for continual improvement and closing the loop in the PDCA cycle. 9. Review and Improve the Audit Process Just as you audit other processes, assess the internal audit process itself as part of your organization's performance evaluation. Common Process-Based Internal Quality Audit Pitfalls to Avoid
A process-based internal quality audit isn't just a requirement—it's a strategic tool for building a culture of quality and performance. By following actual workflows, engaging people, and focusing on results, these audits uncover meaningful insights that go beyond compliance.
For more information on how Accupoint Software can help streamline your internal quality audit program with our innovative QMS software platforms, we invite you to contact us today to schedule your personalized demo. Comments are closed.
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