ISO 9001 Audit Findings Log Template

Introduction

Achieving ISO 9001 certification is an important goal for any organization. It demonstrates the company’s commitment to quality and customer satisfaction. In turn, organizations must perform internal and external ISO 9001 audits to ensure that their processes align with their quality management system (QMS) and the ISO 9001 requirements. While internal audits play a critical role in quality management, they also involve the risk of being unable to identify or remediate the issues found in time. Thus, using the ISO 9001 audit findings log template is essential to help organizations keep track of all the observations, findings, and nonconformities. This informative guide discusses the concept of the audit findings log and its essentiality in ISO 9001 compliance and management.

What is ISO 9001 Audit Findings Log?

An ISO 9001 audit findings log is a form that allows auditors to record all the observations, findings, and nonconformities that have been identified during an ISO 9001 audit, internal or external. This tool helps auditees track and eventually resolve the issues identified during the audit. It also includes fields for describing the corrective actions and verifying that they have been implemented correctly.

ISO 9001 audit findings logs are vital in identifying the areas of the audited processes that need improvement. Without them, there would be little hope that the corrective actions would be taken, let alone implemented correctly. Therefore, in addition to serving as a reminder of the issues detected during the audit, the log serves as an action plan for improving the QMS.

Why ISO 9001 Audit Findings Log is Essential for ISO 9001 Compliance and QMS

Overall, the ISO 9001 audit findings log is a crucial tool for several reasons, including the following:

1. It Concentrates All the Information Related to the Audit Findings

Having a log that concentrates all the information related to the findings makes it easier for the auditee to prioritize the corrective actions based on the significance of the identified issues. When the corrective actions are prioritized, they can be implemented in a timely manner, thus improving the QMS more rapidly.

2. It Helps Plan the Corrective Actions

By providing a system to plan corrective actions, the ISO 9001 audit findings log helps the auditee ensure that all the issues will be remediated adequately. It also helps the auditee delegate the responsibility for the corrective actions and set a deadline for submitting the final report.

3. It Helps Demonstrate that the QMS is Continuously Being Improved

One of the objectives of ISO 9001 is to help organizations continually improve their QMS. The findings log helps the organization demonstrate that it takes the corrective actions seriously by verifying that they have been implemented correctly. The management can use the findings log to evaluate the corrective actions, determine what changes had the most positive effect, and identify the corrective actions that need improvement.

4. It Helps the Management Evaluate the Audit Results

In addition to helping the auditee plan the corrective actions, the findings log can help the management evaluate the results of the audit. Having a log helps the auditee report to the management, thus demonstrating that the QMS is continuously being improved in accordance with the ISO 9001 standards.

5. It Can Help During the Next ISO 9001 Audit

After implementing the corrective actions, the auditor will be able to confirm that the QMS has been improved. Thus, the findings log can help the auditee prepare for the next ISO 9001 surveillance or certification audit.

What the ISO 9001 Audit Findings Log Should Contain?

A log should have several sections to ensure that all the corrective actions are planned, implemented, and verified. Organizations can customize the log to identify the corrective actions that the auditee commits to implement. The main sections that an ISO 9001 audit findings log should contain are described below.

1. Information Concerning the Audit

This section should contain general information about the audit, including:

• Date and time.

• Names of the auditor(s) and auditee/department.

• Audit scope.

• Type of audit: Internal, external (certification/surveillance), and supplier.

2. Information Concerning the Finding

This section should identify the audit finding with a unique ID and a short description.

This section should also classify the finding into three categories:

• Nonconformity (NC): A NC means that a specific ISO 9001 standard or a procedure described in the QMS documents has not been met. The NCs can be classified into two types: Major and Minor. The Major NCs signify significant nonconformity, while the Minor NCs signify isolated nonconformity.
  
  

• Observation (OBS): An OBS finding is a statement of fact that has been verified during the audit. After verifying the OBS finding, it can either become a NC or OFI or remain an OBS finding.
  
  

• Opportunity for Improvement (OFI): Finally, OFI refers to an opportunity for improvement that has been identified during the audit.

The auditor should fill out the following subsections:

• Requirement Violated: The requirement that has been violated should be identified by describing the clause (e.g., 6.1, 7.5.3) or the procedure (e.g., Procedure XYZ).
  
  

• Finding Description: A brief and objective description of the finding should be provided.
  
  

• Objective Evidence: The objective evidence supporting the finding should be identified.

3. Corrective Actions

This section should describe how the corrective actions have been planned.

The auditor should identify the root cause of the finding. It is vital to identify the true root cause, as resolving it will ensure that the same issue will not recur. Then, the corrective actions plan should be developed and submitted with a due date.

The corrective actions should be assigned to a person, department, or process that is responsible for implementing them. Finally, the due date for the corrective actions should be provided.

4. Follow-up

This section should contain information concerning the verification of the corrective action effectiveness. To check whether the corrective actions have been properly implemented, the auditor should verify if they have eliminated the issue and prevented it from recurring. The verification date and name of the verifier should be provided. This section should also identify the status of the finding and the date when the finding has been closed.

How to Effectively Use ISO 9001 Audit Findings Log Template?

An audit findings log should be filled out during the audit, and the corrective actions plan should be developed right after the audit is completed. Corrective actions should be implemented as soon as possible to improve the QMS. Organizations can follow the steps described below to use the ISO 9001 audit findings log template effectively.

1. During the Audit

During the iso external audit, auditors should be trained to document all their observations. Findings should be recorded in the ISO 9001 audit findings log template. The findings should be objective and should refer to specific procedures or standards. Thus, when filling out the audit log, auditors should reference specific clauses (e.g., 6.1, 7.5.3) or procedures (e.g., Procedure XYZ) that have been violated. After the audit findings have been recorded, they should be reviewed with the auditee and the owners of the affected processes to ensure that they understand the issues and the scope of corrective actions.

2. Root Cause Analysis and Corrective Actions

This is probably the most crucial step in the whole process. For each NC, an auditor should perform a root cause analysis to identify the true reason why the NC occurred. After the root cause has been identified, corrective actions can be developed. Corrective actions should be assigned to specific persons or departments with a due date.

3. Implementation and Monitoring

The corrective actions should be implemented and monitored to ensure that they have been completed on time. The progress of the corrective actions can be tracked by updating the ISO 9001 audit findings log template. As the corrective actions are being implemented, the status of the findings should be changed to “In Progress.” Once the corrective actions are implemented, the status should be updated to “Closed,” and the verification date should be provided.

4. Verification of Corrective Action Effectiveness

After the corrective actions have been implemented, they should be verified to ensure that they have eliminated the NC and prevented it from recurring. This step should not be overlooked because, without verification, there is no guarantee that the corrective actions have produced the intended effect.

5. Trend Analysis

Corrective actions should be reviewed and analyzed regularly (e.g., during management reviews) to ensure that they have the intended effect. If a certain corrective action does not seem to be working, it should be replaced with another corrective action. In addition, by reviewing the corrective actions, the management can identify the areas of the QMS that need improvement.

The Benefits of ISO 9001 Audit Findings Log

Besides helping the organization to remain compliant with ISO 9001, the findings log has other benefits as well. For example, by helping the organization identify the areas of QMS that need improvement, the findings log ultimately helps the auditor and the auditee work together to improve the QMS. Some of the benefits of using a findings log are described below:

• Improves processes: An organization can improve its processes by addressing the corrective actions and opportunities for improvement.
  
  

• Enhances the quality of products and services: By improving the processes, the organization can ensure that its products and services are of high quality.
  
  

• Increases customer satisfaction: By producing higher quality products and services, the organization can increase customer satisfaction.
  
  

• Improves organizational learning: The findings log promotes organizational learning by helping the organization learn from the identified issues.
  
  

• Helps the organization identify and mitigate risk: An organization can use the findings log to identify and mitigate risk factors.

Selecting or Developing ISO 9001 Audit Findings Log

An organization can develop or purchase the ISO 9001 audit findings log. The audit findings log can be developed in-house or purchased from a third-party supplier. Alternatively, the findings log can be integrated into a QMS software solution to manage the corrective actions more efficiently. Either way, the log should be user-friendly and should provide all the necessary information.