In a laboratory, an undetected or poorly handled nonconformity can have serious consequences: erroneous results, repeat analyses, weakened quality systems, audit difficulties and, in certain contexts, increased risk to patients. Laboratory nonconformity management is therefore not a mere administrative formality. It constitutes a core quality process, directly linked to the reliability of analyses, the safety of individuals and the maintenance of accreditation. ISO 15189:2022 sets out quality and competence requirements for medical laboratories, while ISO/IEC 17025:2017 does the same for testing and calibration laboratories.
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In a context where the ISO 15189, ISO/IEC 17025 standards and accreditation requirements mandate documented, traceable and controlled processes, the question is no longer simply whether to structure the approach, but how to make it more reliable, more responsive and more sustainable on a daily basis. In France, Cofrac emphasizes that accreditation of medical examinations contributes to improving the quality of service provided to patients and the reliability of results.
Key takeaways regarding laboratory nonconformity management:
- A nonconformity is a deviation from a defined requirement: standard, procedure, specification or internal rule.
- Structured handling is based on six steps: detection, recording, analysis, corrective actions (CAPA), verification and closure.
- Traceability makes it possible to document each event, each decision and each action taken.
- Digitalization of the process improves information collection, corrective action monitoring and visibility over recurring deviations.
“Laboratory nonconformity management rests on three inseparable pillars: detecting deviations, documenting them in an actionable manner and addressing their root causes. Without a structured process, incidents remain isolated, corrective actions lose effectiveness and continuous improvement becomes difficult to steer. In 2026, digitalizing this process — through field forms, checklists and dashboards — provides a tangible lever for making nonconformity handling more reliable and for better tracking the actions undertaken.”
1. Laboratory nonconformity management: definition and stakes
A nonconformity in a laboratory is a deviation between what is required and what has actually been done, obtained or recorded. Before building a robust process, it is therefore essential to clarify this concept and distinguish the closely related terms that are often incorrectly used as synonyms.
1.1. Precise definition of a laboratory nonconformity
According to ISO 9000:2015, a nonconformity corresponds to the non-fulfilment of a requirement. In the context of a quality control or medical biology laboratory, this requirement may be normative, regulatory or internal: procedure, specification, quality rule or validated method. The WHO LQSI tool also defines a nonconformity as any event that does not comply with the laboratory’s rules and/or expectations.
It is important to distinguish several concepts:
- Nonconformity: a formal deviation from a defined requirement.
- Anomaly or deviation: a generic term, sometimes used before formal qualification.
- Deviation: an identified and documented departure within a controlled framework, particularly in certain regulated environments.
Concrete examples:
An out-of-specification result, uncalibrated equipment, a procedure not followed or an incomplete record all constitute nonconformities within the meaning of the applicable quality standards. The WHO provides a standardized nonconformity report template precisely for recording this type of event in an actionable manner.
Source: WHO / LQSI, ISO 15189, ISO/IEC 17025. (Link: https://extranet.who.int/lqsi/content/develop-sop-handling-nonconformities-and-start-recording-and-solvingcorrecting-them)
1.2. Types of nonconformities in the laboratory
Nonconformities in the laboratory fall into four main categories:
- Product/result nonconformities: analytical results outside acceptance limits.
- Process or method nonconformities: drift from a validated method, incorrect application of a protocol.
- Documentary nonconformities: missing form, incomplete record, obsolete procedure.
- Equipment/traceability nonconformities: instrument out of calibration, break in sample traceability chain.
This classification does not merely serve to name the deviations. It directly guides root cause analysis, criticality level assessment and the type of corrective and preventive actions (CAPA) to be implemented.
1.3. Consequences of poor nonconformity management
A poorly managed nonconformity can trigger a chain of effects: repeat analyses, delays, lack of evidence, time losses, weakened quality systems and multiplication of secondary deviations.
In a laboratory, the problem is therefore not limited to a simple documentary incident. Inadequate nonconformity management can affect analytical reliability, personnel safety, quality system compliance and the overall credibility of the facility. This is why the subject must be treated as a genuine business process, not as an end-of-chain formality.
Cofrac explicitly links accreditation to the reliability of results and the quality of service provided.
2. Laboratory nonconformity management: structured process in 6 steps
Handling a nonconformity reliably requires a common methodology. Without a clear process, deviations are reported unevenly, responsibilities become blurred and follow-up quickly loses effectiveness.
2.1. The 6 key steps in nonconformity handling
Nonconformity handling is based on a straightforward logic: detect, record, analyze, correct, verify, close. This sequence forms the foundation of an actionable and reproducible quality system.
The WHO recommends developing a dedicated procedure and recording nonconformities in a standardized manner to enable their correction and follow-up.
Here is the recommended process, aligned with the principles expected in structured quality environments:
| Step | Action | Recommended tool |
| 1 — Detection | Reporting by the operator or automated system | Digital field form |
| 2 — Recording | Classification and timestamping of the detected incident | LIMS or digital tool such as Picomto |
| 3 — Root cause analysis | 5 Whys, Ishikawa, 8D | Structured checklist |
| 4 — CAPA actions | Definition, responsible party, deadline | Validation workflow |
| 5 — Verification | Post-action review | Dynamic dashboard |
| 6 — Closure | Protocol update, archiving | Effective traceability system |
This approach provides a clear handling framework. It also makes it possible to transform a one-off reaction into a sustainable process of control and improvement.
2.3. Engaging field teams in reporting
Effective reporting depends directly on the simplicity of the system. The more cumbersome the information escalation process, the more likely minor anomalies will go unreported — even though they are often the first signs of a recurring or deeper problem.
Facilitating field reporting is therefore a major quality issue. Guided forms, the ability to attach photos, immediate submission to the quality manager and a clear data entry template make reporting faster and more consistent. Picomto fits into this approach by simplifying field data collection and making nonconformity reporting smoother and more actionable.
3. Laboratory nonconformity management: digitalization and tools
Digitalizing nonconformity management addresses three concrete needs: better traceability, better data collection and better monitoring. In demanding quality environments, it does not merely serve to replace paper, but to make the process more reliable and more actionable.
3.1. Why digitalize this process?
A paper-based process quickly shows its limitations: information losses, lack of reliable timestamping, difficulty in consolidating data, poor visibility over statuses and excessively long processing times.
Digitalization improves traceability, information flow and real-time monitoring. LIMS cover part of this need. They can be complemented by dedicated tools for work instructions, field forms and quality action management.
3.2. Key features of an appropriate digital tool
An effective tool should offer:
- Creation and management of quality control checklists and procedures.
- Field data collection (forms, photos, electronic signatures).
- Automatic generation of intervention reports.
- Dynamic dashboards for analyzing recurring nonconformities.
- Multi-device accessibility: smartphone, tablet, computer, augmented reality glasses.
The issue is not adding yet another tool, but having a medium that is genuinely useful for field staff, quality management and CAPA tracking.
3.3. How does Picomto address these needs?
Picomto is a SaaS solution dedicated to the digitalization of work instructions, procedures, checklists and field forms. In the context of nonconformities, its value lies in its ability to structure data collection, facilitate information escalation and make actions more visible.
Concrete use case: A laboratory technician detects a nonconformity on a piece of equipment. They open Picomto on their tablet, fill in the guided form, take a photo of the anomaly and submit the report. The quality manager receives an immediate notification. The deviation is recorded, timestamped and integrated into the handling workflow.
The Picomto Remote Expert solution also enables users to consult a remote expert to validate a complex anomaly without travel. This can accelerate decision-making and secure quality handling in certain situations.
4. Laboratory nonconformity management: traceability, monitoring and continuous improvement
Effective nonconformity management rests on three pillars: precisely documenting each deviation, tracking action progress and leveraging incidents to durably improve practices. Without these three dimensions, handling remains incomplete.
4.1. Traceability: a non-negotiable regulatory obligation
In a laboratory, each nonconformity must be justifiable, trackable and retrievable. This requires a clear record: date, context, responsible party, action taken, associated evidence, verification and closure.
Traceability is not only useful during audits. It also serves to secure decisions, prevent oversights and provide a reliable view of the actual handling of deviations. Insufficient traceability weakens the quality system as much as it does operational management.
The WHO LQSI resources specifically emphasize the use of standardized forms and documented handling of nonconformities.
4.2. Structuring an effective monitoring system
An effective monitoring system relies on clear statuses, identified responsibilities and straightforward visibility over open, in-progress, verified or closed actions. Without this, CAPAs accumulate, timelines stretch and effectiveness assessment becomes difficult.
Dynamic dashboards make it possible to better track recurrences, timelines, criticality levels and handling progress. Picomto contributes to this centralization by structuring quality information and facilitating its use by the relevant managers.
4.3. From nonconformity to continuous improvement
Considering how to handle a nonconformity is not enough. Actionable lessons must also be drawn from it. Root cause analysis, procedure revision, document updates and recurrence monitoring make it possible to transform a one-off incident into a lever for continuous improvement.
It is at this level that nonconformity management ceases to be purely reactive. It becomes a quality management tool for reducing repetitive deviations and durably strengthening field practices.
5. Preventing nonconformities in the laboratory: best practices
The best nonconformity is one that is prevented. In the laboratory, prevention rests first on the clarity of instructions, the consistency of practices and the accessibility of the right materials at the right time.
Rather than constantly correcting the consequences of deviations, it is more effective to act upstream through structured practices, appropriate tools and better dissemination of work instructions.
5.1. Personnel training and practice standardization
A significant proportion of nonconformities stems from execution deviations, divergent interpretations or incomplete knowledge of procedures. Training personnel therefore does not merely consist of conveying a rule, but of securing a common practice.
Training must be continuous, understandable and linked to real field situations. Illustrated, guided materials accessible in the work environment promote this standardization. Picomto can be used in this approach as a medium for dissemination, adoption and harmonization of practices.
5.2. Digital work instructions and risk reduction
Clear and accessible work instructions reduce interpretation errors and limit avoidable deviations. Conversely, scattered, obsolete or hard-to-access documents mechanically increase the risk of incorrect execution.
Digital work instructions enable better dissemination, smoother updates and immediate access to the correct instructions. Used properly, they strengthen operational compliance and support analytical reliability across all relevant workstations.
5.3. Integrating nonconformity management into the QMS
Nonconformity management must not operate in isolation. It must be connected to the overall Quality Management System: internal audits, management review, document control, action tracking, risk analysis and continuous improvement.
This integration is essential. It ensures that deviations are not treated as isolated events, but as useful signals for evolving the organization, procedures and practices.
Conclusion
Laboratory nonconformity management is a strategic process. It determines the reliability of results, the safety of individuals, the robustness of the quality system and the maintenance of accreditation. A structured approach — from detection to closure, then to capitalization — enables better handling of deviations and better prevention of their recurrence.
In this context, digitalization is not a technological overlay. It is a concrete means of strengthening traceability, accelerating monitoring, streamlining field data collection and making quality actions genuinely manageable.
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FAQ
What are nonconformities in the laboratory?
They are deviations from a defined requirement: standard, internal procedure, analytical specification or regulatory requirement applicable to the laboratory.
What are the 3 types of nonconformity?
Generally, a distinction is made between product/result nonconformities, process or method nonconformities, and documentary or regulatory nonconformities.
What is a nonconforming event in a laboratory?
Any detected incident deviating from a requirement: out-of-specification result, uncalibrated equipment, procedure not followed or incomplete record.
How should a nonconformity be handled?
In six steps: detect and report, record, analyze causes, define corrective actions (CAPA), verify their effectiveness, then close and capitalize documentarily.
What is a nonconformity in a medical laboratory?
Any deviation from ISO 15189 requirements or the Public Health Code: sample identification error, erroneous result transmitted, non-compliance with a validated sampling procedure.
Key takeaways
- Laboratory nonconformity management is based on a clear process: detection, recording, analysis, corrective action, verification and closure.
- Complete traceability makes it possible to document deviations, secure decisions and track the actions undertaken.
- Digitalization of the process improves field data collection, CAPA monitoring and visibility over recurring nonconformities.
- Prevention relies on clear, accessible and well-disseminated work instructions.
- Continuous improvement becomes real when deviations are analyzed, monitored and leveraged to evolve practices.
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