Don't Skip Internal Audits: Ensuring Compliance with ISO 17025

For laboratories striving to achieve or maintain ISO 17025 accreditation, the importance of internal audits cannot be overstated. These audits are not just a compliance requirement; they are a powerful tool to ensure quality, identify risks and promote continual improvement. Laboratories that prioritize internal audits position themselves as leaders in reliability and technical competency. Here's why skipping internal audits could be detrimental and how embracing them can elevate a laboratory's performance.

The Purpose of Internal Audits in ISO 17025

Internal audits serve as a mirror, reflecting the laboratory’s adherence to ISO 17025 standards and its own quality management system (QMS). They provide an opportunity to:

1. Evaluate Compliance: Internal audits ensure that the laboratory meets the ISO 17025 requirements and any applicable regulatory obligations.

2. Detect Non-Conformities: By identifying gaps or deviations early, internal audits prevent minor issues from escalating into significant problems.

3. Encourage Continuous Improvement: Audits uncover areas for improvement, driving the laboratory toward higher efficiency and effectiveness.

4. Prepare for External Assessments: Internal audits act as a rehearsal for external audits, reducing stress and surprises during accreditation or surveillance visits.

Skipping internal audits is akin to neglecting routine health checkups. While the consequences may not be immediate, they can lead to long-term deterioration in quality and credibility.

The Consequences of Skipping Internal Audits

1. Increased Risk of Non-Compliance - Without regular audits, laboratories risk deviating from ISO 17025 requirements, leading to non-conformities that could jeopardize accreditation status.

2. Missed Opportunities for Improvement - Internal audits highlight inefficiencies and risks that may otherwise remain undetected. Skipping them could result in missed opportunities for innovation and cost savings.

3. Compromised Credibility - Clients and stakeholders expect accredited laboratories to uphold the highest standards. Failing to conduct internal audits undermines trust and damages reputation.

4. Stress During External Audits - Without the preparatory benefit of internal audits, laboratories face a higher likelihood of surprises and non-conformities during external assessments.

   
   

How to Conduct Effective Internal Audits

To maximize the value of internal audits, laboratories should follow a structured approach:

1. Develop an Audit Plan

   • Identify the scope, objectives and criteria of the audit.

   • Schedule audits at regular intervals, ensuring coverage of all critical processes.

2. Train Auditors

   • Select auditors with a thorough understanding of ISO 17025 and the laboratory’s QMS.

   • Ensure that auditors are impartial and independent of the areas being audited.

3. Focus on Risk-Based Thinking

   • Assess processes for potential risks and opportunities in alignment with ISO 17025 principles.

4. Use Checklists and Tools

   • Develop checklists tailored to the laboratory’s specific operations.

   • Leverage digital tools or software to streamline data collection and reporting.

5. Engage All Stakeholders

   • Encourage open communication and participation from all staff members.

   • Use the audit as a learning opportunity to reinforce a culture of quality.

6. Document Findings

   • Record all observations, including conformities, non-conformities and areas for improvement.

   • Prioritize findings based on their impact on quality and compliance.

7. Take Corrective Actions

   • Address non-conformities promptly with corrective and preventive actions.

   • Monitor the effectiveness of these actions to prevent recurrence.

     
     

Internal Audits: A Continuous Journey

Internal audits are not a one-time activity but an ongoing journey. They must evolve in response to changes in laboratory processes, technologies and regulatory requirements. By embracing a mindset of continuous improvement, laboratories can transform audits from a compliance obligation into a strategic advantage.

Case Study: The Power of Internal Audits

Consider a medium-sized materials testing laboratory that implemented robust internal audit practices as part of its ISO 17025 journey. During an internal audit, the team discovered discrepancies in equipment calibration records. Though minor, these discrepancies had the potential to impact test results.

The laboratory promptly addressed the issue by:

1. Revising its calibration procedures.

2. Training staff on record-keeping best practices.

3. Implementing an automated tracking system for calibration schedules.

These actions not only resolved the non-conformity but also enhanced the laboratory’s overall efficiency and accuracy. When the external audit occurred, the auditors commended the laboratory’s proactive approach, further solidifying its credibility.

The IQAS Advantage

At International Quality and Accreditation Services (IQAS), we understand the pivotal role of internal audits in achieving ISO 17025 compliance. Our expert consultants provide tailored guidance to help laboratories:

• Design and implement effective internal audit programs.

• Train auditors to identify and address non-conformities effectively.

• Interpret ISO 17025 requirements in the context of specific laboratory operations.

With IQAS, laboratories gain a trusted partner committed to their journey of excellence.

Conclusion

Internal audits are the unsung heroes of ISO 17025 compliance. They safeguard the integrity of a laboratory’s operations, ensure continuous improvement and build confidence among clients and stakeholders. By prioritizing internal audits, laboratories can not only meet but exceed the expectations of ISO 17025, securing their reputation as leaders in quality and reliability.

So, the next time you're tempted to skip an internal audit, remember: It's not just an audit; it's an investment in your laboratory’s future.