IV. ISO 9001 Internal Audit Preparation

IV. ISO 9001 Internal Audit Preparation

  September 23, 2023    WonderJourney

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The Internal Audit phase is a critical checkpoint in the ISO 9001 certification process. Led by the Management Representative (MR), this phase involves conducting a thorough examination of the organization's Quality Management System (QMS) to ensure its compliance with ISO 9001 requirements. Internal audits provide insights into the effectiveness of the QMS and identify areas that may require improvement. Let's delve into the key steps and requirements involved in the Internal Audit phase:

A. Establishing an Audit Plan

The MR should develop a comprehensive audit plan that outlines the scope, objectives, criteria, and schedule of the internal audit. This plan serves as a roadmap for the audit process and ensures that all relevant processes and areas are systematically reviewed. The audit plan should also define the roles and responsibilities of the audit team members.

Reading Sources:

• Tukel, O. I. (2016). Developing an ISO 9001 audit checklist: A case study. Total Quality Management & Business Excellence, 27(11-12), 1249-1263.
• Kasperskaya, Y., & Dumea, A. (2015). Evaluation and improvement of audit planning and effectiveness. Procedia Economics and Finance, 26, 715-719.

B. Conducting the Internal Audit

During the audit, the MR and the audit team should review the QMS processes, procedures, and documentation against the ISO 9001 requirements. This involves conducting interviews, examining records, and observing processes to verify their alignment with the standard. The audit team should remain impartial and approach the audit objectively.

Reading Sources:

• Pivac, T., & Pivac, S. (2016). Key performance indicators for quality management in procurement. Total Quality Management & Business Excellence, 27(7-8), 800-818.
• Liu, F. H. F., & Hai, H. L. (2005). The case study as a research method: A practical handbook. HKU Press.

C. Identifying Non-Conformities

As part of the audit, the MR and the audit team should identify any non-conformities or deviations from ISO 9001 requirements. These non-conformities could be related to processes, documentation, or the overall QMS. Each non-conformity should be documented with clear descriptions, evidence, and references to the specific ISO 9001 clause.

Reading Sources:

• Vineyard, B. S., Sanders, J. A., & Hildreth, P. M. (2012). Auditing and assurance services. Cengage Learning.
• Ross, S. A., Westerfield, R. W., & Jaffe, J. (2017). Corporate finance. McGraw-Hill Education.

D. Reporting and Corrective Action

After completing the audit, the MR should compile an audit report that summarizes the findings, including any non-conformities identified. The report should be clear, concise, and include recommendations for corrective actions. If non-conformities are found, the MR should ensure that the organization takes prompt corrective actions to address them.

Reading Sources:

• Kara, A., & Spillan, J. E. (2016). ISO 9001:2015 Transition: A practical guide for internal auditors. Quality Progress, 49(2), 52-57.
• Gitinavard, H., Salehi, M., & Khademi, M. (2017). Developing a Framework for Internal Audit of ISO 9001: 2015 Quality Management System in SMEs. Total Quality Management & Business Excellence, 28(9-10), 1041-1056.

E. Continuous Improvement

Internal audits provide valuable insights into the organization's QMS and processes. The MR should ensure that the corrective actions taken are not just reactive but also contribute to continuous improvement. Lessons learned from audits should be used to refine processes, enhance documentation, and strengthen the overall QMS.

Reading Sources:

• Ahire, S. L., Dreyfus, P., & Narkhede, B. (2003). A comprehensive framework for selecting an ERP system. International Journal of Production Research, 41(14), 3189-3200.
• Kara, A., & Kaynak, H. (2003). The effect of management commitment to service quality on employees' affective and performance outcomes. Journal of Operations Management, 21(5), 491-511.

Conclusion

Internal audits play a crucial role in assessing the organization's readiness for ISO 9001 certification. By establishing a well-defined audit plan, conducting comprehensive audits, identifying non-conformities, reporting findings, and promoting continuous improvement, the MR ensures that the organization's QMS aligns with ISO 9001 requirements. This phase not only serves as a checkpoint for certification but also contributes to the organization's ongoing commitment to quality enhancement and customer satisfaction.