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Internal ISO 9001 Audit Program

Choosing an Audit Team

You will want to have a number of trained internal auditors for your audit program. You will be auditing each area of your facility once or twice a year, with an audit team of 1 to 4 auditors depending on the size of the area. You will want to have enough auditors trained so that the auditors will not audit their own area, and so that you are not pulling one person away from their work too often. A general guidance number is 10% of the total number of employees; a company with 50 employees would train 5 auditors, and company of 100 would train 10. As the number of employees goes up, the percentage would go down.

Look for employees that have a strength in investigating issues and that are good communicators. The better people skills the auditors have, the smoother your audits will be performed.

Audit Tips

Internal Audits are a Quality Management System’s best friend. Audit findings lead to great improvement in the effectiveness and efficiency of the system. How can you make your internal audit program work for your organization? Here are some tips to help get the most from your internal audits.

Before an Audit

During an Audit

After the Audit

One Last Tip

Involve your people! Use audits as opportunities to train others. Ask for a volunteer (who is not an auditor) to walk through the audit process with you as an assistant. This will provide others with a better understanding of what audits are and why they are necessary.

Involving people creates a feeling that everyone is a vital contributor to the goal of the company - compliance.

Auditing when there is no Documented Procedure

With the new documentation requirements giving the responsibility of determining what documents are needed for control of processes, it will become part of the auditor's responsibility to determine if the necessary procedures and work instructions have been documented. How can an auditor determine if a process is controlled if there is no procedure or work instruction?

As an auditor, you must evaluate if the process is being performed consistently, with consistent and acceptable results. An auditor can do this by asking several of the people performing the process questions. Ask the people the questions individually, so they do not influence one another's' answers. If the process is in control, the answers will be consistent. Some sample questions:

Ask enough people to give you a good idea of how much the process varies between each individual performing the process. If the answers vary, there should be a procedure. The need for a procedure will generally depend on the complexity of the process and the training of the people responsible for the process.

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