Learn how to quickly implement a business-friendly ISO system. Common situations in which you'll benefit from outsourcing ISO implementation tasks. The internal audit program is a self-check mechanism which organizations use to periodically verify they meet ISO requirements. ISO internal auditing is required by the standard. But audits are not only necessary to maintain ISO registration, they're also a powerful tool for improving the effectiveness of the quality management system QMS and the efficiency of operational processes.
In this article, we'll explain what ISO internal audits are, how to benefit from them, and what you need to do to ensure compliance. Before examining the internal audit process, it's worth comparing them to external audits. While internal and external audit activities are usually the same, they are performed for different reasons and often have a different scope. External audits are undertaken by a third party — usually an auditor or team of auditors appointed by your company's registrar.
They could also be conducted by a customer or other interested party. These types of external audits are often more limited in scope and focus on particular aspects of your quality system.
Internal audits, on the other hand, are performed in-house as a self-check mechanism at periodic intervals. The internal auditor or audit team are company employees who've been appointed and trained as ISO auditors, usually as an additional responsibility. Identify processes that require improvement in order to ensure the QMS remains fully implemented. The audit process involves the Document Review , which is where auditors check whether documentation meets ISO requirements, and the Process Review , which consists of checking actual business activities against documentation and looking for discrepancies.
ISO internal audits apply the Process Approach which means that the auditor reviews a sequence of work activities rather than picking an ISO requirement and checking if the requirement is correctly implemented. Essentially, the ISO auditor would observe an activity, ask the operator questions, and request to view related documents and records.
It's common practice for the internal auditor to cross-check what was said and verify records in other departments, for example, training records in the HR department. Auditors can't assess every single process, employee and document in the company, so it's important they exercise judgement in picking a representative sample.
The actual auditing process is generally straightforward. An internal auditor checks whether procedures and other documentation adheres to ISO requirements and then verifies that employees follow the procedures in their daily routines.
This can get difficult, though, when there is no procedure or work instruction document for the auditor to refer to. While ISO does not require procedures and work instructions for all processes, it does require such documentation where it adds value to the company. It is important to emphasize that process documentation is for the internal benefit of the company — not for the convenience of the auditor.
Companies are neither required nor encouraged to develop procedures and work instructions that assist auditors. In the absence of process documentation, the auditor will use a combination of employee interviews, observation of actual work processes and review of records to determine if the process conforms to ISO requirements and is effectively implemented.
During this process, the auditor also evaluates if procedures and work instructions would be beneficial and, therefore, required. When auditors have to rely more on employee interviews than observation of actual work processes, the best approach is to ask each employee the same set of questions and cross-check their answers for consistency.
If these answers aren't consistent, the auditor will need to check further to see if this due to actual inconsistencies in which work is performed, if there is a need for standardization and work instructions, if there is a need for training, if the entire process requires review and improvement, or if there are other factors involved.
As important and useful as internal audits are, some business owners dread them. There are company owners who believe that ISO internal audits merely duplicate the work of registrars. For them, internal audits represent a waste of resources and an unnecessary disruption of regular work activities.
Other business owners view internal auditors as a kind of business police force, hiding essential data and sometimes outright lying to maintain the illusion of compliance. The truth is that these criticisms are only justified if the ISO internal audit program is incorrectly implemented. In fact, well-set-up ISO audit program could be leveraged to become one of the most powerful tools to improve your business. You will need to perform at least one internal audit two or three months prior to the certification audit.
This will produce audit reports and records of corrective action that show where your organization's weak points are ie, nonconformities and your plans to address them. T hank you for producing documents of this quality ". Bettye Patrick.
United Plating, Inc. Calculating Audit Time. How do you determine the number of audit days needed for an organization? Buy the Standard ISO Key processes should have an increased audit frequency. From the example audit schedule, the organization determined that the Design and Development process,and the Assembly process were the key processes and as such, scheduled these processes for 2 audits per year.
A review of past audit reports showed that the organization had issues with their Control of Nonconforming Product process. This also was given an increased audit frequency.
The finished internal audit schedule is shown below. All key internal processes are shown on the schedule. Again, the internal audit schedule must show that all processes your company has identified appear on the audit schedule. Notice that the example company chose not to include Training, Control of Documents, or Control of Records.
Instead, they chose to audit these topics as support processes to every process on their schedule. Read more about support processes on the Internal Audit Checklist page. Follow Us On Twitter! The Internal Audit Schedule While the ISO standard doesn't specifically require an internal audit schedule, it is the easiest way to keep your audit program on track.
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