Internal auditing is an essential part of the ISO 9001:2015 standards for developing a quality management system (QMS). We reviewed the essential steps required to create a good internal inspection program in a previous article, Five Main Steps in ISO 9001 Internal Audit. Even if you are following the audit process exactly as planned, it is crucial to know how to record any nonconformities you find so that customers may easily explore them.
What exactly is a nonconformity?
In the context of an ISO 9001 audit, a nonconformity occurs when evidence is discovered that a procedure was not carried out as planned and in compliance with the requirements of the standard. The purpose of the audit is to compare the process's intended arrangements to what is happening and to ensure that the adheres that are implemented conform to what is expected. In brief, when we audit, we expect compliance, but when we find evidence that this is not the case, we have identified a nonconformity.
This is when a nonconformity statement in the audit report is required.
What are the rules for writing a solid nonconformity statement?
So, how can you ensure the quality of your nonconformity statement? It is critical to recall why we are creating a nonconformity declaration in the first place. The statement is written in the audit report to allow the auditee to take action to address the issue and eliminate the cause.
Some guidelines can be followed to accomplish this:
- Include the prerequisite. To establish that there is a problem, be certain that the person who will resolve the nonconformity understands the requirement.
- Include a description of what went wrong. You are writing the nonconformity so that the auditee may investigate what went wrong, and, therefore describe the issue you discovered. You must state the actual audit conclusion you reached based on the evidence you obtained.
- Include audit documentation. There should be enough information for the person to begin investigating the matter as soon as possible. This means you should add a reference to the audit proof that you discovered.
This provides the auditee with a starting point for their research into the fundamental cause of the problem, allowing corrective action to be performed more rapidly. Evidence is frequently offered by referring to actual documented information.
Audit findings are more valuable with good nonconformity assertions.
We need suitable nonconformity statements so that those who need to correct the process may get to the core cause and corrective action as quickly as possible. We can ensure that the internal audit process benefits the firm and helps improve the QMS in the best way feasible by identifying nonconformities in enough information.
In summary, the audit nonconformity statement should provide all of the information required for the individual conducting the investigation. You want to disclose the information you discovered so that an investigation can take place, however, you don't want to assign responsibility or give directions on what should be done. The auditor communicates the problem that's been discovered, not the solution that must be executed.
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