Understanding The Iso 17025 Internal Audit Cycle

By Author: Emma
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In today's highly regulated laboratory world, staying compliant with ISO 17025 is not just a necessity—it's a foundation of credibility and excellence in operation. An important part of this standard is the internal audit cycle, a process that helps assure the quality management system is effective, efficient, and consistently improving.

But what does the internal audit cycle of ISO 17025 entail, and why is it so important?

The Purpose of Internal Audits
The use of internal audits is to evaluate the effectiveness of an organization's internal controls, risk management, and governance. They assist in ensuring compliance with policies and laws, preventing fraud, and enhancing operational effectiveness. Internal audits offer great insights for management decision-making.

Such audits are used to:
• Try to identify areas of non-conformance
• Highlight opportunities for improvement
• Prevent future issues through proactive analysis
• Validate corrective actions

Phases of the Internal Audit Cycle
An internal audit cycle generally follows a carefully laid-out ...
... process. Each one is linked, creating a loop that enhances improvement continuously.

Planning and Scheduling
The cycle starts with a yearly audit plan. This plan lays out what should be audited, when, and by whom. Priority usually goes to processes that are high-risk or have previously demonstrated non-conformity.

Preparation
Documentation, such as procedures, prior audit results, and reports of corrective action, is collected by auditors. The process is essential for adapting the audit to the lab's unique needs.

Execution
The audit is performed by the auditor via interviews, observation, and review of documents. It's not just a search for defects, but an assessment of the success of systems implemented.

Reporting
Audit results are written in a clear manner, based on factual objective evidence. Conformities and non-conformities are stated, with recommendations.

Corrective Actions
Corrective action plans have to be established and followed for any non-conformities discovered. Plans should deal with the root cause, not just symptoms.

Follow-Up
Auditors check that corrective actions are effective to ensure problems are corrected. Where required, follow-up audits can be performed.
Review and Improvement

Audit results are channelled into review processes by management, which aid in formulating strategic decisions regarding improvement, resource allocation, and training requirements.

Who should do internal audits?
Hiring the proper staff is essential. Auditors must be neutral and qualified. They do not have to be outside consultants but must be free from the industry being audited. ISO 17025 auditor training is widely invested in by many laboratories so that their internal personnel possess the skills and qualifications necessary to audit effectively and professionally.

The ISO 17025 internal audit cycle is crucial to ensure compliance, credibility, and operational excellence. It entails planning, preparation, execution, reporting, corrective action, follow-up, and review. Internal audits evaluate effectiveness, identify non-conformance, and facilitate continual improvement. Qualified, unbiased auditors ensure quality management systems are effective and compliant with ISO 17025 standards.