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Lecture summary:

  • The internal audit is one instrument for self-review of whether requirements are achieved
  • Specify the responsible parties that will participate in the audit
  • The auditor should gather all the information, data, findings, nonconformities, and opportunities for improvement and present them together in one report

 

An internal audit is an effective tool that is used for self-assessment of your organization and to determine the extent to which it fulfills the QMS requirements.

The audit findings will show you the effectiveness of your QMS and identify nonconformities and opportunities for improvement.

 

ISO 9001 requirements

One of the essentials is that you conduct internal audits at planned intervals.  At the end of that activity, you need to see whether your QMS conforms to your requirements for the QMS. It shall provide you information on whether the QMS is effectively implemented and maintained.

Practically you have to define, implement, and maintain an internal audit program that includes the following:

  • The frequency and intervals of the audit
  • The methods for conducting the audit
  • Roles and responsibilities that take part in an internal audit
  • Planning requirements
  • Reporting the results

 

Audit program

An audit program is a series of steps or specifications required by the organization to be able to conduct the audit. The goal of the program is that you identify the required organizational elements that will be audited and determine when they will be audited.

You have to maintain a documented program for conducting an audit.  You also have to specify the authorities and responsible parties that will participate in the audit (the auditor or audit team, employees, specific roles, management representatives, technical experts, etc.).

You also have to include a description of the agenda or topics and issues that will be audited and discussed.  It is recommended that you publish and communicate the audit program. The program can appear as a list or a procedure.

Try to integrate this such as schedule, information for the opening of the audit, changes in the QMS, results of the last audit, open non-conformities, required resources, etc.

You may manage a general plan that will refer to all the organizational units and ask to evaluate the performance of procedures and work instructions, evaluate quality procedures, and sample evidence of executing those processes.

In the end, the audit must provide the ability to evaluate whether the QMS is effective or not. You must have a summary report that will communicate the results to the appropriate persons in your company.

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