Maintaining the highest standards of quality and accuracy is the cornerstone of every testing and calibration laboratory. ISO/IEC 17025, the globally recognized standard for laboratory competence, ensures that laboratories produce valid and reliable results. One of the most critical components of ISO 17025 compliance is the handling of nonconforming work. Effective management of nonconformities safeguards data integrity, prevents recurrence, and strengthens the laboratory’s quality management system (QMS).
In this blog, we will explore how laboratories should handle nonconforming work as per ISO 17025 guidelines and why engaging expert ISO 17025 Consultants in Bangalore can help achieve seamless compliance.
What is Nonconforming Work?
Nonconforming work refers to any deviation from established procedures, standards, or customer requirements that could affect the validity of laboratory results. This can occur due to:
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Equipment malfunction or calibration drift
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Human errors during testing or reporting
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Incorrect sampling methods
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Deviation from test procedures
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Use of expired or unsuitable materials
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Environmental conditions affecting results
Identifying and addressing such nonconformities is essential to maintain the credibility of the laboratory’s operations and uphold ISO 17025 standards.
Steps for Handling Nonconforming Work in an ISO 17025 Laboratory
The ISO 17025 standard provides a structured approach for managing nonconforming work. Laboratories seeking ISO 17025 Certification in Bangalore must establish and implement procedures that clearly define how to identify, control, and rectify nonconformities.
1. Identification of Nonconforming Work
The first step involves detecting any deviation that may compromise the validity of results. Detection can occur during:
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Internal audits
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Routine quality control checks
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Review of test reports
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Customer feedback or complaints
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Staff observations
Every laboratory staff member must be encouraged to report potential nonconformities immediately. An open and blame-free culture promotes early detection, reducing the risk of recurring issues.
2. Immediate Actions and Notification
Once nonconforming work is identified, the laboratory must take immediate action to control its impact. This includes:
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Halting the affected test or calibration activities
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Labeling or isolating suspect items
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Informing the customer if the results are invalid or delayed
Transparency with clients is vital for maintaining trust. The laboratory must document the nature of the nonconformity, the personnel involved, and the immediate steps taken to contain it.
3. Evaluation of the Nonconformance
After containment, the laboratory evaluates the significance of the nonconformance. The evaluation should determine:
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Whether the nonconformity affects previously reported results
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If retesting or recalibration is required
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The potential impact on customer decisions
If results have been issued based on nonconforming work, corrective communication with the customer must be initiated immediately.
4. Root Cause Analysis
Identifying the root cause is a fundamental step to ensure that corrective actions are effective. Common tools used for root cause analysis include:
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The 5 Whys technique
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Fishbone (Ishikawa) diagrams
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Failure Mode and Effects Analysis (FMEA)
A well-conducted root cause analysis allows laboratories to pinpoint underlying issues—whether procedural, equipment-related, or human factors—and prevent recurrence.
5. Corrective Action Implementation
Once the root cause is established, corrective actions must be implemented. These actions could include:
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Retraining personnel
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Revising test methods or SOPs
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Repairing or recalibrating equipment
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Improving environmental controls
Documentation of corrective actions is mandatory under ISO 17025. Each action should be verified to ensure it effectively eliminates the problem and prevents similar issues from arising in the future.
6. Monitoring and Verification
The effectiveness of corrective actions must be evaluated over time. Regular follow-ups, audits, and performance reviews help verify that the implemented measures are successful. Continuous monitoring is key to sustaining laboratory quality and maintaining compliance with ISO 17025 requirements.
Documentation and Record Keeping
Proper documentation is a cornerstone of ISO 17025 compliance. Laboratories must maintain records that include:
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Description of the nonconformity
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Date and personnel involved
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Actions taken to control and correct the issue
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Root cause analysis report
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Verification of effectiveness
Accurate records serve as evidence during ISO 17025 Certification in Bangalore audits and demonstrate a laboratory’s commitment to continual improvement.
The Role of ISO 17025 Consultants in Bangalore
Achieving and maintaining ISO 17025 compliance can be complex, especially for laboratories managing large volumes of testing or calibration work. Partnering with experienced ISO 17025 Consultants in Bangalore provides significant advantages:
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Expert guidance in developing a robust nonconformance management procedure
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Assistance with documentation and audit preparation
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Tailored training for laboratory staff
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Streamlined certification process through professional ISO 17025 Services in Bangalore
These consultants ensure that laboratories not only meet but exceed ISO 17025 requirements, enhancing operational efficiency and credibility.
Benefits of Properly Managing Nonconforming Work
Effective handling of nonconforming work contributes to multiple long-term benefits:
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Improved accuracy and reliability of test results
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Strengthened client confidence and satisfaction
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Reduction in repeat errors and operational downtime
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Enhanced reputation for technical competence
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Smooth and successful ISO 17025 certification audits
By adopting a proactive approach to identifying and rectifying nonconforming work, laboratories can foster a culture of continuous improvement.
Conclusion
The handling of nonconforming work is not just a compliance requirement—it is a critical quality assurance practice that ensures trust, reliability, and scientific integrity in laboratory operations. ISO 17025 sets a clear framework for identifying, evaluating, and correcting deviations in a structured, transparent, and traceable manner.
For laboratories in Bangalore aspiring to enhance their credibility and achieve global recognition, partnering with professional ISO 17025 Consultants in Bangalore can make the journey smoother. Through expert ISO 17025 Services in Bangalore, your laboratory can build a robust system that minimizes errors, strengthens client relationships, and drives continual improvement—all essential elements for maintaining ISO 17025 Certification in Bangalore.