ISO/IEC 17025 is the global benchmark for testing and calibration laboratories, ensuring they demonstrate competence, impartiality, and consistent operations. Achieving accreditation under this standard is a mark of quality, but maintaining it requires rigorous audits.
One of the most important outcomes of these audits is the identification of non-conformities (NCs). These highlight where a laboratory’s practices, processes, or documentation fail to comply with ISO/IEC 17025 or its own procedures.
For laboratories, understanding, preventing, and addressing non-conformities is essential not only for accreditation but also for building credibility with customers and regulators.
What are Non-Conformities in ISO/IEC 17025 Audits?
A non-conformity is any deviation from:
ISO/IEC 17025 requirements,
The laboratory’s documented quality management system, or
Customer/regulatory obligations.
They are recorded during internal audits or audits by external accreditation bodies (e.g., NABL in India, UKAS in the UK, ANAB in the US). Each non-conformity must be addressed through corrective and preventive actions (CAPA) before accreditation can be granted or maintained.
Classification of Non-Conformities
Non-conformities are generally classified as:
Major Non-Conformity
A serious issue that directly affects the validity of results or indicates a systemic failure.
Example: Using expired calibration standards in testing.
Minor Non-Conformity
A less severe issue that does not immediately compromise results but still breaches requirements.
Example: Training records missing a supervisor’s signature.
Observation / Opportunity for Improvement (OFI)
Not a non-conformity but a suggestion from the auditor for better practices.
Example: Recommending more precise traceability in calibration records.
Common Non-Conformities in ISO/IEC 17025 Audits
Based on global audit findings, the most frequent non-conformities include:
1. Document Control Issues
Outdated procedures or SOPs in circulation.
Missing document approvals or uncontrolled copies.
Inconsistent versioning and poor accessibility.
2. Equipment and Calibration Gaps
Equipment used beyond calibration due dates.
Lack of traceability to national or international standards.
Incomplete maintenance and intermediate check records.
Missing calibration certificates or unverifiable references.
3. Personnel Competency & Training
No documented training plans.
Staff performing tests without competency evaluations.
Lack of evidence for ongoing technical competence.
4. Test Method Validation & Measurement Uncertainty
Non-standard methods not validated.
Missing or incorrect uncertainty of measurement estimates.
Inadequate verification for transferred methods.
5. Sampling & Test Records
Incomplete raw data or worksheets.
Missing traceability for samples.
Errors in reporting results due to manual entries.
6. Internal Audits & Management Reviews
Internal audits do not cover all clauses of ISO/IEC 17025.
Late or incomplete management review meetings.
Audit findings were not followed up with corrective actions.
7. CAPA (Corrective and Preventive Actions) Failures
Root cause analysis was not performed or was poorly documented.
Same NCs recurring from previous audits.
Ineffective CAPA verification processes.
Corrective Actions for Non-Conformities
When a non-conformity is raised, labs must follow a structured CAPA process:
Identify & Record – Clearly document the non-conformity with evidence.
Root Cause Analysis – Techniques such as the 5 Whys or Fishbone diagrams should be employed.
Implement Corrective Action – Fix the immediate issue (e.g., recalibrate equipment, update SOP).
Preventive Action – Establish controls to prevent recurrence.
Verification of Effectiveness – Ensure changes are sustained and effective during follow-up audits.
How to Prevent Non-Conformities in ISO/IEC 17025 Audits
Prevention is better than correction. Laboratories can reduce audit findings by:
Maintaining strict document control with proper approvals and versioning.
Scheduling timely calibrations and maintaining traceability to SI units.
Keeping complete training and competency records for staff.
Validating test methods and documenting uncertainty calculations.
Conducting effective internal audits that mimic external audit rigor.
Using digital systems to eliminate manual errors and improve traceability.
Role of Calibration Management Software in ISO/IEC 17025 Compliance
Calibration-related NCs are among the most frequent findings in ISO/IEC 17025 audits. Paper-based logs or spreadsheets often lead to missed calibration schedules, incomplete records, and poor traceability.
This is where Calibration Management Software becomes essential:
Automated Calibration Reminders – Prevent overdue calibrations.
Traceability Records – Maintain links to national/international standards.
Centralized Equipment Database – Store calibration history, certificates, and service logs.
Audit-Ready Reports – Generate detailed calibration and maintenance reports instantly.
Error Reduction – Minimize manual entry mistakes with digital logs.
By digitizing calibration processes, labs can drastically reduce NCs and demonstrate strong compliance to auditors.
Discover Zeptac Calibration Management Software and learn how it enables laboratories to stay ISO/IEC 17025 audit-ready.
FAQs on Non-Conformities in ISO/IEC 17025 Audits
Q1. What is a non-conformity in ISO/IEC 17025?
Answer: It is any deviation from ISO/IEC 17025 requirements, the laboratory’s documented procedures, or customer expectations, identified during an audit.
Q2. What are examples of major non-conformities?
Answer: Examples include using uncalibrated equipment, missing records of measurement uncertainty, or failure to validate test methods.
Q3. How can labs avoid non-conformities?
Answer: By maintaining strict document control, timely equipment calibration, competency records, and performing robust internal audits.
Q4. What is the most common non-conformity in ISO/IEC 17025 audits?
Answer: Calibration and equipment management issues are the most frequent, followed by documentation and competency records.
Q5. How does calibration software help in ISO/IEC 17025 compliance?
Answer: Calibration management software automates reminders, maintains traceability, stores certificates, and generates audit-ready reports, thereby minimizing non-conformities.
Conclusion
Non-conformities in ISO/IEC 17025 audits can hinder accreditation and damage customer confidence. However, by identifying common pitfalls, implementing corrective actions, and leveraging digital solutions, laboratories can ensure compliance and continuous improvement.
Among all findings, calibration-related non-conformities remain the most common. By adopting Calibration Management Software, labs can reduce risks, maintain audit readiness, and strengthen their reputation for accuracy and reliability.
Take the next step: Discover Zeptac Calibration Management Software and make your lab audit-ready today.