A non-conformity during an ISO 15189 assessment can feel like a major setback, especially after months of preparation. However, most non-conformities are not a sign of failure—they are opportunities to strengthen laboratory systems, improve patient safety, and build a more reliable quality management system.
This article explains why non-conformities occur, how medical laboratories can address them effectively, and the practical steps needed to move confidently toward ISO 15189 accreditation.
Understanding ISO 15189 Non-Conformities
An ISO 15189 non-conformity is identified when a medical laboratory does not fully meet one or more requirements of the standard. During an assessment, auditors review documents, observe laboratory activities, interview personnel, and examine records to determine whether the laboratory complies with the standard.
Non-conformities may be related to technical operations, quality management, documentation, equipment, staff competency, or risk management. Identifying these issues early helps laboratories improve their systems before they affect patient care or accreditation status.
It is important to remember that finding non-conformities is a normal part of the laboratory accreditation process. Even well-managed laboratories receive observations that require corrective action.
Common Reasons Laboratories Receive Non-Conformities
Many issues identified during assessments are preventable with regular internal monitoring.
Some of the most common causes include:
Incomplete or outdated Standard Operating Procedures (SOPs)
Missing records for equipment calibration and maintenance
Insufficient staff competency evaluations
Weak document control practices
Inadequate internal audits
Poor corrective and preventive action (CAPA) implementation
Incomplete risk assessment documentation
Lack of evidence for quality improvement activities
Most of these issues develop gradually rather than overnight, making routine internal reviews essential.
ISO 15189 Requirements That Often Need Extra Attention
Document Control
Every document should have version control, approval records, and periodic review. Laboratories often struggle when outdated procedures remain in circulation or staff continue using obsolete forms.
Personnel Competence
Medical laboratories must demonstrate that staff members are trained, competent, and regularly evaluated. Training records alone are not enough; competence assessments should also be documented.
Equipment Management
Equipment should be properly maintained, calibrated where applicable, and monitored throughout its lifecycle. Missing maintenance logs or delayed calibration schedules frequently lead to non-conformities.
Internal Audits
Internal audits should evaluate whether the quality management system is functioning effectively—not simply complete a checklist. Findings should result in meaningful corrective actions.
Corrective Actions
One of the most common assessment findings is addressing only the immediate problem without identifying its root cause. Effective corrective actions should prevent the issue from recurring.
How to Respond to ISO 15189 Non-Conformities
Receiving a non-conformity does not mean accreditation is out of reach. The response process is what matters most.
Step 1: Understand the Finding
Read each observation carefully and identify exactly which requirement has not been met. Avoid making assumptions or rushing into corrective actions before understanding the root issue.
Step 2: Perform a Root Cause Analysis
Instead of correcting only the visible problem, determine why it occurred.
For example:
If staff members consistently skip a quality control step, the underlying issue may not be employee negligence. It could involve inadequate training, unclear procedures, excessive workload, or insufficient supervision.
Addressing the actual cause creates a stronger and more sustainable solution.
Step 3: Implement Corrective Actions
Corrective actions should directly eliminate the identified root cause.
Examples include:
Revising laboratory procedures
Retraining laboratory personnel
Updating maintenance schedules
Improving documentation systems
Introducing additional quality checks
Every action should be documented with supporting evidence.
Step 4: Verify Effectiveness
The laboratory should confirm that corrective actions have solved the issue and prevented recurrence. Follow-up internal audits and management reviews are valuable tools for verifying effectiveness.
Practical Example
Consider a medical laboratory where reagent storage temperatures are not consistently recorded.
The immediate correction may be updating the missing records.
However, the root cause analysis reveals that temperature monitoring responsibilities were never formally assigned.
The laboratory responds by:
Assigning responsible personnel
Updating the SOP
Training staff
Introducing a daily monitoring checklist
Reviewing compliance during monthly internal audits
This approach addresses both the symptom and the underlying problem.
Preventing Future Non-Conformities
The best strategy is prevention rather than correction.
Medical laboratories can reduce future findings by:
Conducting scheduled internal audits
Reviewing SOPs regularly
Monitoring quality indicators
Performing routine staff competency assessments
Maintaining complete equipment records
Encouraging staff to report quality concerns early
Holding regular management review meetings
Continuous improvement is one of the core principles of ISO 15189 accreditation, and laboratories that embrace this approach are generally better prepared for future assessments.
The Role of Accreditation Bodies
Working with experienced ISO 15189 accreditation bodies helps laboratories better understand assessment expectations and accreditation requirements.
Preparation should focus on building an effective quality management system rather than simply preparing for an assessment. Laboratories that integrate quality into everyday operations generally experience smoother assessments and stronger long-term compliance.
For organizations operating multiple laboratory types, quality systems may also align with standards such as ISO 17025 for testing or calibration lab accreditation, where applicable. Although each standard has different requirements, strong documentation, competency management, and continual improvement remain common principles.
Building a Stronger Quality Culture
Accreditation should not be viewed as a one-time achievement. The most successful laboratories create a culture where quality becomes part of everyday work.
When management supports continuous improvement, employees receive regular training, and documentation is consistently maintained, laboratories become more resilient to assessment findings. This not only supports medical lab accreditation but also improves operational efficiency, reduces errors, and increases confidence in laboratory results.
Getting Back on Track with Confidence
Non-conformities are part of the improvement journey, not the end of it. Every finding provides valuable insight into strengthening laboratory processes, improving documentation, and enhancing patient care.
Medical laboratories that respond systematically—through root cause analysis, effective corrective actions, and continuous monitoring—are well positioned to move forward in the laboratory accreditation process and maintain compliance with ISO 15189 requirements.
If your laboratory is preparing for ISO 15189 accreditation or working to resolve assessment findings, FDAS India provides accreditation services for medical laboratories in accordance with ISO 15189:2022.
Contact FDAS India at +91 124 495 9882, +91 8448278215, email fdasindia@hotmail.com, or visit www.fdasindia.org to learn more about the accreditation process.
