Common ISO/IEC 17025 Non-Conformities and How to Avoid Them

Laboratories across the globe strive for technical excellence, but maintaining compliance with ISO17025 often becomes challenging. As the international standard for testing and calibration laboratories, ISO 17025 sets stringent requirements for quality management, technical competence, and accurate results. Understanding common non-conformities and proactively addressing them helps laboratories achieve and sustain accreditation efficiently.

Understanding ISO 17025

ISO 17025 (also referred to as ISO/IEC 17025) outlines the general requirements for the competence of testing and calibration laboratories. It ensures that laboratories operate impartially, use valid methods, and deliver reliable results. Compliance with this standard is mandatory for laboratories seeking recognition from any Accreditation Body or aiming for clinical lab accreditation or medical testing lab accreditation.

Whether a laboratory performs chemical analysis, mechanical testing, or clinical diagnostics, following ISO 17025 demonstrates its commitment to quality, consistency, and global recognition.

Common Non-Conformities Found During ISO 17025 Audits

Many laboratories face recurring issues during internal audits or assessments by Accreditation Bodies. These non-conformities often arise from gaps in documentation, improper implementation of procedures, or inadequate staff training. Some of the most frequently observed non-conformities include:

• Incomplete or outdated documentation: Laboratories often fail to maintain updated procedures, work instructions, and records. Missing or obsolete documents can lead to inconsistent testing practices.
  

• Insufficient method validation: Not fully validating analytical or testing methods leads to uncertainty about the accuracy and reliability of results.
  

• Improper equipment calibration and maintenance: Inadequate calibration schedules or incomplete calibration records can result in questionable test data and non-compliance with ISO 17025 requirements.
  

• Lack of staff competency records: laboratory accreditation agencies sometimes neglect to document staff qualifications, training history, and competence evaluations—critical aspects for ISO/IEC 17025 compliance.
  

• Failure to manage non-conforming work: Many labs fail to establish clear processes for identifying, reporting, and correcting non-conforming test results.
  

• Inadequate measurement uncertainty estimation: Incorrect or incomplete calculation of measurement uncertainty impacts the validity of reported results.
  

• Poor internal audit practices: Internal audits that overlook technical aspects or fail to evaluate the effectiveness of corrective actions can lead to recurring non-conformities.
  

• Unclear complaint handling procedures: Laboratories are required to handle client feedback and complaints systematically, yet this area is frequently overlooked or poorly documented.
  

Root Causes Behind Non-Conformities

Understanding the underlying causes behind non-conformities helps laboratories implement sustainable corrective measures. Some common root causes include:

• Lack of awareness about ISO 17025 requirements
  

• Insufficient staff training or high turnover rates
  

• Weak quality management culture within the organization
  

• Over-reliance on external consultants without internal ownership
  

• Outdated laboratory information management systems (LIMS)
  

• Poor communication between management and technical staff
  

Identifying and correcting these causes builds a more robust quality management system aligned with ISO/IEC 17025 principles.

How to Avoid ISO 17025 Non-Conformities

Avoiding non-conformities requires an integrated approach that combines documentation control, personnel competence, internal audits, and continuous improvement. Laboratories can follow these best practices to ensure compliance and readiness for accreditation assessments:

1. Strengthen documentation control: Keep all policies, procedures, and records regularly updated. Implement a version control system to track document revisions.
   

2. Ensure proper staff training: Train laboratory personnel on method-specific procedures, ISO 17025 clauses, and quality management principles. Competence assessments should be documented and reviewed periodically.
   

3. Maintain equipment calibration schedules: Develop a clear calibration and maintenance plan for all instruments. Partner only with accredited calibration providers to ensure traceability and accuracy.
   

4. Validate test methods: Conduct full method validation or verification before implementation, documenting all results and uncertainties as per ISO/IEC 17025 guidelines.
   

5. Conduct thorough internal audits: Schedule regular internal audits covering both technical and management requirements. Ensure corrective actions from previous audits are verified for effectiveness.
   

6. Implement an effective corrective action system: Every non-conformity must be analyzed, corrective measures implemented, and results monitored. Use root cause analysis tools such as the 5 Whys or Fishbone Diagram to identify real issues.
   

7. Foster a culture of continuous improvement: Encourage feedback from staff and clients. Use audit findings, complaints, and improvement suggestions to enhance processes and system efficiency.
   

8. Leverage automation tools: Digital quality management systems help reduce human errors, maintain proper document control, and streamline audit readiness.
   

Role of Accreditation Bodies

Accreditation Bodies play a critical role in evaluating laboratory compliance with ISO 17025. They review documentation, audit technical competence, and assess continuous improvement mechanisms. Engaging proactively with these bodies helps laboratories understand expectations, interpret requirements accurately, and maintain consistent quality.

Organizations such as the Federation for Development of Accreditation Services assist laboratories in understanding the accreditation process, conducting pre-assessment audits, and aligning their quality management systems with international standards. Their guidance can significantly reduce the likelihood of non-conformities during formal accreditation.

You can also read this:- Why do we need ISO/IEC 17025 -Testing and calibration laboratories

Benefits of Eliminating Non-Conformities

Addressing and preventing non-conformities offers several advantages beyond mere compliance. Laboratories that maintain ISO 17025 conformance experience improved efficiency, reduced testing errors, enhanced reputation, and higher client trust. Moreover, they gain a competitive advantage in bidding for projects requiring accredited testing reports or analytical results.

When laboratories work with experienced support organizations like the Federation for Development of Accreditation Services, they benefit from expert training, documentation guidance, and mock assessments. This collaborative approach ensures long-term compliance with ISO/IEC 17025.

Conclusion

ISO 17025 compliance is not just about passing audits—it reflects a laboratory’s dedication to reliability, accuracy, and continuous improvement. By identifying common non-conformities and implementing preventive measures, laboratories can maintain accreditation, enhance client confidence, and contribute to the credibility of scientific data. Ultimately, a well-managed ISO 17025 system strengthens both technical performance and overall business excellence.