Mastering ISO 9001:2015 Internal Auditing: A Comprehensive Guide for Continuous Improvement
Introduction:
Welcome to an in-depth exploration of ISO 9001:2015 internal auditing! Internal audits are a crucial element of an effective Quality Management System (QMS), ensuring compliance with standards and driving continuous improvement. In this article, we’ll break down everything you need to know about internal audits, from requirements and audit planning to nonconformity management and corrective actions.
Understanding Internal Auditing:
Internal auditing is vital for organizations aiming to uphold ISO 9001:2015 standards and improve their processes. During these audits, auditors systematically look for evidence of compliance and effectiveness in meeting standards while identifying areas for enhancement.
It is common to uncover nonconformities—instances where processes don’t meet ISO requirements. However, these aren’t about assigning blame. Instead, nonconformities are treated as system issues, not personal ones, and are opportunities for improvement.
For example, if an audit reveals that a manufacturing process is not consistently meeting quality standards, the focus is on identifying the root cause—such as outdated equipment or insufficient training—rather than blaming the operators. This approach fosters a culture of collaboration and problem-solving.
ISO 9001:2015 Internal Audit Requirements:
Let’s delve into the specific requirements of internal auditing as per ISO 9001:2015.
1. Conduct Internal Audits at Planned Intervals
Internal audits must be conducted at planned intervals. These audits are never a surprise; they’re scheduled in advance to ensure all relevant processes and requirements are thoroughly reviewed.
Two essential tools for planning audits include:
· Audit Schedule: Outlines audits over an extended period (typically 6 months to a year) and is available to all applicable personnel. For instance, a company might schedule audits for its production, procurement, and customer service departments at different times throughout the year.
· Audit Plan: Details specific audit information such as scope, objectives, and who will be involved. It’s provided to auditees in advance and serves as a roadmap for the audit. For example, an audit plan might specify that the production department will be audited for compliance with ISO 9001:2015 clauses 8.5 (Production and Service Provision) and 8.6 (Release of Products and Services).
· Audit Frequency: ISO 9001:2015 doesn’t prescribe specific audit frequencies, but a common practice is to audit all processes within the management system at least once a year. This ensures comprehensive coverage and compliance.
Audits should also be tailored to the specific requirements of each department, as not all ISO 9001:2015 elements apply universally. For example, the finance department may not need to be audited for compliance with clause 8.5 (Production and Service Provision), but it should be audited for compliance with clause 7.1.4 (Environment for the Operation of Processes).
Key Objectives of Internal Auditing:
Internal auditors focus on three main objectives:
1. Determine Conformance to the Organization’s Requirements
Auditors assess whether the system conforms to the organization’s own requirements, such as policies, procedures, work instructions, and checklists. For example, if your organization has a specific checklist for product inspection, auditors would verify compliance with these internal standards.
Example: A company might have a procedure for handling customer complaints. During an audit, the auditor would check whether the complaints are logged, investigated, and resolved according to the procedure.
2. Ensure Conformity to ISO 9001:2015
Auditors must ensure conformity to ISO 9001:2015 itself. This involves understanding and applying the standard’s criteria to organizational operations. Thorough auditor training and continuous education are crucial for effective compliance assessment.
Example: An auditor might verify whether the organization has established measurable quality objectives (clause 6.2) and whether these objectives are being monitored and reviewed regularly.
3. Evaluate the Effectiveness of the Management System
Meeting ISO 9001:2015 requirements isn’t enough. Auditors must determine whether the system is effectively implemented and maintained to achieve objectives, satisfy customers, and drive continual improvement. For instance, if customer satisfaction scores have improved since implementing new quality measures, it indicates system effectiveness.
Example: If an audit reveals that customer complaints have decreased by 20% over the past year, it suggests that the quality management system is effective in addressing customer concerns.
Building an Effective Internal Audit Program:
Planning, establishing, implementing, and maintaining an audit program is vital for ISO 9001:2015 compliance. While the standard doesn’t explicitly require a documented procedure, it’s highly recommended.
A written audit program outlines:
· How audits are planned, conducted, reported, and recorded.
· Who performs these activities.
· Training requirements for internal auditors.
· Guidelines for gathering evidence and identifying nonconformities.
· Formal reporting requirements and corrective action processes.
Example: A manufacturing company might create an audit program that includes:
· A schedule for auditing each department quarterly.
· A checklist for auditors to use during the audit.
· A template for reporting audit findings and corrective actions.
Key Elements of an Audit Procedure:
Here are some key elements typically addressed in an internal audit procedure:
1. Audit Schedule Maintenance: Assign responsibility for maintaining the audit schedule.
2. Auditor Training: Ensure auditors are well-trained to assess compliance effectively.
3. Audit Planning: Clearly communicate the audit plan to all stakeholders.
4. Evidence Gathering: Provide guidelines for collecting relevant and sufficient evidence.
5. Nonconformity Identification: Define what constitutes nonconformity to ensure consistency.
6. Reporting Requirements: Document findings and track corrective actions.
7. Corrective Action: Ensure prompt and effective corrective actions to prevent recurrence.
8. Follow-Up: Verify the effectiveness of corrective actions.
9. Management Review: Include audit results in management reviews for strategic decision-making.
Example: A company might define nonconformity as any deviation from documented procedures or ISO 9001:2015 requirements. During an audit, if an auditor finds that a process is not being followed as documented, they would report it as a nonconformity and recommend corrective action.
Ensuring Objectivity and Impartiality:
Objectivity and impartiality are critical in internal audits. Avoid assigning auditors to areas where they may have conflicts of interest, such as auditing their own department. To maintain objectivity:
· Train a team of auditors every 12 to 18 months.
· Build a diverse group of auditors to minimize bias.
Example: If an auditor has a close personal relationship with a manager in the department being audited, they should not be assigned to that audit. Instead, another auditor with no personal ties should conduct the audit.
Corrective Actions: The Heart of Continuous Improvement:
ISO 9001:2015 requires that audit nonconformities lead to corrective actions. Here’s the difference between correction and corrective action:
· Correction: Immediate action to eliminate a detected nonconformity (e.g., replacing a broken machine component).
· Corrective Action: Systematic process to identify and eliminate the root cause of a nonconformity (e.g., investigating why the component failed and revising maintenance schedules).
Corrective actions should be initiated without undue delay—typically within a week—and their duration depends on the complexity of the issue.
Example: If an audit reveals that a supplier’s materials are consistently non-compliant, a correction might involve rejecting the current batch of materials. The corrective action would involve investigating the root cause (e.g., poor supplier quality control) and implementing measures to prevent recurrence, such as finding a new supplier or improving supplier oversight.
Documenting Audit Programs and Results:
ISO 9001:2015 emphasizes retaining documented information about your audit program and its results. This includes:
· Corrective Actions: Documents showing nonconformities, causes, actions taken, and follow-up.
· Audit Notes/Checklists: Proof that the audit took place and evidence gathered.
· Auditor Training Records: Ensuring auditors meet competency requirements.
Optional but recommended records include audit reports and audit plans, which provide a balanced view of the audit and guide performance.
Example: A company might keep a record of an audit that identified a nonconformity in the production process. The record would include the audit findings, the corrective actions taken, and evidence that the issue was resolved.
The Importance of Audit Follow-Up:
While ISO 9001:2015 doesn’t specifically address follow-up, it’s strongly recommended. Follow-up involves verifying that corrective actions were effective and achieved the intended results. This ensures that audit findings lead to lasting improvements.
Example: If an audit identified a nonconformity in the training process, the follow-up would involve verifying that the training program was updated and that employees have completed the new training.
Real Survey Questions to Test Your Knowledge:
Here are some questions to reflect on:
1. How does your organization select and train internal auditors?
2. What criteria determine the scope and objectives of internal audits?
3. How do you ensure objectivity and impartiality in audits?
4. How are audit findings documented and reported?
5. Can you provide examples of how audit findings led to corrective actions or improvements?
Conclusion:
Effective and lasting internal audits with corrective actions are key to maintaining a robust quality management system. By following ISO 9001:2015 guidelines, organizations can drive continuous improvement, enhance customer satisfaction, and achieve their objectives.
If you found this guide helpful, share it with your peers and subscribe to our channel for more insights. Leave your questions in the comments below—we’d love to hear from you!
Thanks for reading, and see you next time!
Comments