ISO 9001:2015 Clause 9.2.2 outlines specific requirements for the conduct of internal audits within an organization, focusing on ensuring the Quality Management System (QMS) conforms to:
- The organization’s own requirements for its quality management system;
- The requirements of the ISO 9001:2015 standard itself.
This clause emphasizes the need for a systematic, independent, and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which audit criteria are fulfilled. Here are the key components detailed in Clause 9.2.2:
Planning and Preparation
- Audit Program: Organizations must plan, establish, implement, and maintain an audit program that considers the importance of the processes concerned and the results of previous audits. The audit program should outline the frequency, methods, responsibilities, planning requirements, and reporting for the audits.
- Scope and Criteria: Each audit must have a defined scope and criteria, ensuring a focused approach that adequately assesses the relevant aspects of the QMS.
Execution
- Selection of Auditors: Auditors must be selected to ensure objectivity and impartiality of the audit process. The selection should consider the competence of the auditors, ensuring they have the appropriate knowledge and skills to effectively conduct the audits.
- Conducting Audits: The organization must ensure that audits are conducted in accordance with the organization's procedures, following the planned scope and criteria.
Reporting and Follow-Up
- Documenting Information: The organization must maintain documented information as evidence of the implementation of the audit program and the audit results.
- Audit Report: After the audit, a report must be prepared that details the findings and conclusions of the audit. This report is crucial for the management review process and for planning corrective actions.
- Corrective Actions: When audit findings reveal nonconformities or areas for improvement, the organization is required to take appropriate corrective actions. These actions should be aimed at addressing the root cause of the nonconformities to prevent their recurrence.
Continuous Improvement
- Feedback into the QMS: The results of internal audits should be used as an input for the continual improvement of the QMS. This involves analyzing audit findings, trends, and performance over time to identify opportunities for system-wide improvements.
Clause 9.2.2 ensures that internal audits are conducted in a manner that provides management with the information necessary to understand whether the QMS is effectively implemented and maintained, and whether it conforms to the specified requirements. This process is fundamental to the continual improvement of the QMS, ensuring the organization’s ability to consistently meet customer and regulatory requirements.