5 Steps in an ISO 9001 Internal Audit

Every organisation that is committed to achieving and maintaining the highest quality standards should perform regular ISO 9001 internal audits. Internal audits are a crucial aspect of the quality management system (QMS) as they help to ensure that processes are working effectively, and they identify areas for improvement. 

With that in mind, let’s break down the five essential steps in an ISO 9001 internal audit, ensuring a comprehensive and effective audit process.

Step 1: Planning the Audit Schedule

The first step in conducting an ISO 9001 internal audit is to establish an audit schedule. This schedule should be developed based on the organisation’s size, complexity, and risk areas. It is crucial to plan the audit schedule in advance to ensure that sufficient resources and time are allocated to the audit process. Additionally, the schedule should be flexible enough to accommodate any changes or unforeseen events that may arise during the audit process.

When planning the audit schedule, consider the following factors:

• The frequency of audits: Depending on the organisation’s needs, audits can be conducted annually, bi-annually, or quarterly. The frequency should be determined by considering the organisation’s complexity, size, and identified risks.
• The scope of the audit: Define the areas to be audited, the processes, and the relevant ISO 9001 clauses. This will help the audit team focus on the most critical aspects of the QMS.
• The audit team: Select auditors who are experienced, knowledgeable, and trained in ISO 9001 requirements. The audit team should also be independent of the area being audited to ensure objectivity.

Step 2: Planning the Process Audit

Once the audit schedule is established, the next step is to plan the process audit. This involves defining the audit objectives, scope, criteria, and methodology. During this stage, the audit team will:

• Review the organisation’s QMS documentation, including policies, procedures, and records.
• Develop an audit plan that outlines the audit’s objectives, scope, criteria, and methodology.
• Prepare an audit checklist to ensure that all relevant aspects of the QMS are covered during the audit process.

Step 3: Conducting the Audit

The audit team will conduct the audit by gathering objective evidence through interviews, observations, and document reviews. The audit process should follow the audit plan and checklist to ensure that all relevant areas of the QMS are assessed. The auditors should remain objective and impartial during the audit process, avoiding any personal biases or opinions.

Some best practices for conducting the audit include:

• Establishing rapport with the auditee: This helps create a comfortable environment for the auditee and encourages open communication.
• Asking open-ended questions: This allows the auditee to provide more information and enables the auditor to gain a better understanding of the QMS.
• Documenting findings: The auditor should record all findings, both positive and negative, to ensure that a comprehensive report is generated at the end of the audit process.

Step 4: Reporting on the Audit

After the audit is completed, the audit team will prepare a formal audit report outlining the findings. This report should be clear, concise, and objective, presenting both the positive aspects of the QMS and the areas where improvements are needed. The report should also include recommendations for corrective actions and potential improvements.

The audit report should be presented to the organisation’s management, who are responsible for addressing the findings and implementing the necessary corrective actions. It is essential to involve top management in the audit process to ensure their commitment to continuous improvement and compliance with ISO 9001 requirements.

Step 5: Follow-up on Issues or Improvements Found

The final step in the ISO 9001 internal audit process is to follow up on the issues or improvements identified during the audit. This involves monitoring the implementation of corrective actions, verifying their effectiveness, and ensuring that the improvements are sustained over time.

The audit team should establish a follow-up schedule and maintain communication with the auditee to track the progress of corrective actions. This follow-up process is crucial in ensuring that the organisation’s QMS remains effective and continually improves, ultimately leading to increased customer satisfaction and business success.

The Bottom Line

A well-executed ISO 9001 internal audit is an invaluable tool for driving continuous improvement within your organisation. By following these five key steps—from planning the audit schedule to following up on issues or improvements found—you can ensure that your audit process is efficient, effective, and contributes to the ongoing success of your quality management system.

Securing ISO 9001 certification in Sydney is a strategic move for businesses looking to enhance their credibility, improve operational efficiency, and gain a competitive edge. Contact us at ISO 9001 Consultants today to get started!