ISO 9001 Clause 9.2 requires organizations to conduct internal audits of their quality management system (QMS) to determine its effectiveness and identify opportunities for improvement. Here's a breakdown of the requirements:
- Internal Audit Program: The organization must establish, implement, and maintain an internal audit program that covers all the requirements of the ISO 9001 standard and its own QMS. The program must be based on the results of previous audits, changes to the QMS, and the organization's objectives.
- Internal Auditors: The organization must select internal auditors who are independent of the audited activity and competent in auditing techniques and the applicable requirements of the ISO 9001 standard and the organization's QMS. The auditors must also be trained on the QMS and audit techniques.
- Internal Audit Process: The organization must plan, conduct, and report on internal audits in a systematic and documented manner. The process should cover the following steps:
- Audit planning: Define the audit scope, objectives, and criteria, and select the audit team.
- Audit preparation: Review relevant documents, interview personnel, and perform any necessary activities before the audit.
- Audit execution: Conduct the audit, document findings, and communicate with auditees.
- Audit reporting: Document and communicate the audit results to the relevant personnel, and recommend corrective actions if necessary.
- Audit follow-up: Verify the implementation and effectiveness of corrective actions.
- Records: The organization must maintain records of the internal audit program, including audit plans, findings, and corrective actions.
By complying with the requirements of Clause 9.2, organizations can ensure that their QMS is effective and continuously improving.
ISO 9001- Clause 9.2 Internal audit -What are the objectives?
Clause 9.2 of ISO 9001 specifies the requirements for internal audits. The objectives of internal audits are as follows:
- To ensure that the quality management system (QMS) conforms to the requirements of ISO 9001 and to the organization's own requirements, policies, and procedures.
- To identify areas for improvement in the QMS, including opportunities for cost savings, efficiency gains, and enhanced customer satisfaction.
- To verify the effectiveness of corrective actions taken in response to nonconformities identified in previous audits or other assessments.
- To provide feedback to top management on the performance of the QMS and any needed improvements.
- To verify the competence of auditors and to provide training and development opportunities to enhance their skills and knowledge.
- To promote a culture of continuous improvement within the organization.
Overall, the objective of internal audits is to ensure that the QMS is effective, efficient, and continuously improving, leading to improved customer satisfaction, product quality, and business performance.
Why Does ISO 9001 require internal audits?
ISO 9001 requires internal audits to ensure that an organization's Quality Management System (QMS) is effective and consistently meeting the organization's requirements and those of its customers. Internal audits help to identify areas for improvement in the QMS, including opportunities for cost savings, efficiency gains, and enhanced customer satisfaction.
Internal audits are also required to verify the organization's compliance with ISO 9001 requirements, as well as with its own policies, procedures, and objectives. This helps to ensure that the organization is maintaining the necessary level of quality in its products or services, and that it is continuously improving its QMS.
Additionally, internal audits provide an opportunity for top management to review the QMS and make any necessary changes or improvements. By regularly conducting internal audits, an organization can maintain a high level of quality and continuously improve its processes, ultimately leading to increased customer satisfaction and business performance.
In summary, internal audits are a crucial part of ISO 9001, helping organizations to maintain an effective QMS, ensure compliance with standards and policies, and continuously improve their operations.