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ISO 9001 is an international standard that sets out the criteria for a quality management system (QMS). The primary aim is to ensure that organizations consistently provide products and services that meet customer and regulatory requirements while aiming for continual improvement. An internal audit is an essential part of the ISO 9001 QMS. Its purpose is to assess and ensure the QMS’s effectiveness and identify areas for improvement.
The following components are typically included in an ISO 9001 internal audit:
- Audit Planning: Define the scope, criteria, and objectives of the audit. This involves determining which processes or departments will be audited, the standards to which they’ll be compared, and what the objectives of the audit are.
- Review of Documentation: Before conducting the audit, auditors review the documented QMS to understand the procedures, processes, and policies the organization has in place.
- Opening Meeting: This is a brief meeting at the start of the audit where the audit team meets with the auditee (the person or team being audited) to explain the purpose, scope, and process of the audit.
- Process Auditing: The core activity where auditors will:
- Observe activities and processes in action
- Review records and evidence of process outcomes
- Interview staff and stakeholders about how processes are conducted
- Verify that the QMS processes are being followed and that they’re effective
- Recording Nonconformities: Any deviation from the established QMS or from ISO 9001 requirements is noted as a nonconformity. Nonconformities are categorized, typically as:
- Minor nonconformity: A single observed lapse in the system
- Major nonconformity: A systemic failure or an absence of a process or procedure
- Closing Meeting: At the end of the audit, the audit team meets again with the auditee to discuss the findings, any nonconformities, and potential recommendations.
- Audit Report: After the audit, the auditors will produce a report detailing:
- The scope and objective of the audit
- A summary of the audit findings
- Details of any nonconformities, including evidence and classification
- Recommendations for corrective actions or areas of improvement
- Follow-Up: Depending on the findings and the organization’s internal processes, there might be a follow-up audit or review to ensure that corrective actions were taken and are effective.
- Continuous Improvement: The whole idea behind the ISO 9001 QMS is continual improvement. Therefore, the insights gained from the internal audit should be used to refine and improve processes, address weaknesses, and better meet customer and regulatory requirements.
When performing an ISO 9001 internal audit, it’s important to have competent auditors who understand the standard, the organization’s internal processes, and the principles of auditing. Often, organizations will train their own staff to conduct these audits or hire external consultants to ensure objectivity and expertise.