LabQMHub Editorial Team · ISO 15189:2022 Quality Management Series
No laboratory, however well managed, is immune to error. What separates a mature quality system from a fragile one is not the absence of nonconforming work, but the presence of a disciplined, immediate, and thorough process for identifying it, containing its impact, and resolving it before it reaches — or, if it already has, after it reaches — a patient.
ISO 15189:2022’s Clause 7.5, Nonconforming work, formalizes exactly this process, distinguishing genuine nonconformity from a mere inconvenience, and establishing what an appropriate response actually requires.
Defining Nonconforming Work Precisely
Nonconforming work is any aspect of the laboratory’s activities — a process, a procedure, or a result — that does not meet its own defined requirements or those of ISO 15189:2022, distinguished from a nonconformity, which is the broader finding that something failed to conform, whether discovered through routine work or through audit. This distinction matters because nonconforming work specifically refers to problems identified during the laboratory’s actual operations, requiring immediate operational response.
Recognizing nonconforming work requires staff throughout the laboratory to understand what ‘normal’ looks like well enough to notice a deviation — an unexpected quality control pattern, an implausible result, a specimen that does not match its accompanying paperwork — and to feel empowered to flag it immediately rather than assuming someone else will catch it.
Immediate Response and Containment
The first priority upon identifying nonconforming work is containment — stopping the affected process, quarantining affected specimens or reagents, and preventing further reportable results from being generated using the compromised process until the issue is understood. Containment decisions must be made quickly, often by whoever first identifies the problem, which is why clear escalation authority and defined containment procedures matter so much.
Containment also requires assessing whether any results have already been released using the nonconforming process — connecting directly to the notification and reporting principles covered in the previous course — since a contained process going forward does not undo harm already caused by results already in a clinician’s hands.
Evaluating Extent and Impact
Once contained, the laboratory must evaluate how far back the nonconformity’s effects may extend — was this an isolated event, or does it trace back to a change, such as a new reagent lot or a software update, that may have affected results over a longer period than initially suspected? Underestimating the scope of impact is one of the more common and consequential mistakes in nonconforming work management.
This evaluation should be evidence-based, reviewing relevant quality control history, maintenance logs, and any other data that could establish precisely when the nonconformity began, rather than relying on assumption or the earliest moment someone happened to notice a problem.
Documentation and the Path to Resolution
Every instance of nonconforming work should be documented — what happened, how it was identified, the containment actions taken, the evaluated extent of impact, and the resolution — creating a record that supports both accountability and the corrective action process covered later in this program, which addresses the underlying root cause rather than only the immediate instance.
A laboratory that documents nonconforming work thoroughly and without a punitive culture around reporting tends to identify more of it, not less — staff are more willing to flag a concern early, when it is more easily contained, if they trust the response will focus on the process rather than assigning blame.
Frequently Asked Questions
What is the difference between a nonconformity and nonconforming work?
Nonconforming work specifically refers to a laboratory process, procedure, or result failing to meet requirements during actual operations; nonconformity is the broader term covering any failure to conform, however it is discovered.
What should happen first when nonconforming work is identified?
Immediate containment — stopping the affected process and quarantining affected specimens, reagents, or results — before any further evaluation or corrective action begins.
Why is evaluating the full extent of a nonconformity so important?
Because the underlying cause, such as a reagent lot or software issue, may have affected results over a longer period than initially suspected, and underestimating this scope leaves some affected results unreviewed.
Key Takeaways
- Nonconforming work is any laboratory activity that fails to meet its own defined requirements or those of ISO 15189:2022, identified through actual operations.
- Immediate containment — stopping the process and quarantining affected materials — is the first priority upon identification.
- Containment must include assessing whether results were already released using the nonconforming process before it was caught.
- Evaluating the full extent and duration of a nonconformity’s impact prevents underestimating how many results may actually be affected.
- Thorough documentation supports both accountability and the deeper root-cause corrective action process that follows.
- A non-punitive reporting culture leads to earlier identification of nonconforming work, when it is easier to contain and resolve.
Conclusion
Nonconforming work is not a sign of a failing laboratory — it is an inevitable feature of any complex process performed by humans using instruments and reagents that can degrade or fail. What matters is the discipline and speed of the response.
ISO 15189:2022’s requirements in this area ensure that response is systematic, evidence-based, and genuinely protective of patients, rather than an improvised scramble that varies depending on who happens to be on shift when a problem is discovered.
Learn how data and information management protects laboratory results in the next course of this ISO 15189:2022 training series.
Source note: this article draws on “Quality Management in Clinical Laboratory Demystified” by Dr. Taleb Chalab Cham, ISO 15189:2022, and widely recognized clinical laboratory quality references including CLSI guidelines, CAP accreditation checklists, and WHO laboratory quality guidance.
