LabQMHub Editorial Team · ISO 15189:2022 Quality Management Series
A complaint is, in many respects, a gift — it is a patient, clinician, or laboratory user telling the laboratory directly that something did not go as it should have, information that would otherwise remain hidden until the same problem recurred, potentially with worse consequences. How a laboratory receives, investigates, and responds to complaints reveals as much about its quality culture as any internal audit result.
ISO 15189:2022’s Clause 7.7 requires laboratories to have a formal, accessible complaint process, and to treat the resulting data as genuine quality intelligence rather than an administrative nuisance to be resolved and forgotten as quickly as possible.
Why Complaints Deserve Genuine Attention, Not Just Resolution
A laboratory that only aims to close complaints quickly, without genuinely investigating their underlying cause, misses the opportunity complaints represent: each one is a data point about where the laboratory’s processes, communication, or service fell short of expectations, often revealing patterns invisible to internal quality control or routine audit.
Treating complaints as valuable input, not merely a service obligation to be discharged, shifts the laboratory’s posture from defensive to genuinely curious — asking not just ‘how do we resolve this specific complaint’ but ‘what does this complaint tell us about a broader pattern we should address.’
Building an Accessible Complaint Process
Patients, clinicians, and laboratory users need a clear, genuinely accessible way to raise a concern — a process that is not buried in fine print, does not require navigating an intimidating bureaucracy, and is communicated proactively rather than left for people to discover only if they specifically ask how to complain.
Every complaint should be logged, regardless of how minor it initially seems, since a pattern of individually minor complaints about the same issue can reveal a systemic problem that no single complaint, viewed in isolation, would suggest.
Investigating and Resolving Complaints Thoroughly
A genuine investigation traces the complaint back to its actual cause — whether a communication breakdown, a process gap, or a genuine error — rather than accepting the first plausible explanation offered, and connects to the same corrective action discipline covered later in this program when the complaint reveals a true nonconformity requiring systemic fix.
Closing the loop with the complainant — informing them of the investigation’s outcome and any resulting action, not merely that the matter has been ‘resolved’ internally — respects the complainant’s genuine stake in understanding what happened, and is often what determines whether they trust the laboratory going forward.
Trend Analysis: Turning Individual Complaints Into System Insight
Beyond individual resolution, complaint data should be aggregated and analyzed for trends — a rising pattern of complaints about a specific test, department, or type of interaction is a genuine quality signal warranting proactive investigation, distinct from and complementary to the quality indicator monitoring covered later in this program.
This trend data is a required input to management review, ensuring complaint patterns receive visibility at the highest level of laboratory governance, where resource and process decisions capable of addressing systemic patterns can actually be made.
Frequently Asked Questions
Should minor complaints still be formally logged?
Yes — even individually minor complaints can reveal a systemic pattern when aggregated and analyzed over time, information that would be lost if only ‘serious’ complaints were recorded.
What does ‘closing the loop’ with a complainant mean?
Informing the person who raised the complaint of the investigation’s outcome and any resulting action taken, not simply marking the complaint as internally resolved without further communication.
How does complaint data connect to management review?
Complaint trends are a required input to management review, ensuring patterns are visible to laboratory leadership with the authority to address systemic causes.
Key Takeaways
- Complaints provide valuable quality intelligence, revealing patterns that internal quality control or routine audit alone might miss.
- An accessible, proactively communicated complaint process encourages genuine reporting rather than silent dissatisfaction.
- Every complaint should be logged, since a pattern of individually minor complaints can reveal a larger systemic issue.
- A thorough investigation traces the complaint to its actual root cause, connecting to the laboratory’s broader corrective action process.
- Closing the loop with the complainant by explaining outcomes and actions taken builds lasting trust, beyond simply resolving the immediate issue.
- Aggregated complaint trend data is a required input to management review, ensuring visibility at the highest level of governance.
Conclusion
A laboratory’s relationship with complaints says a great deal about its overall quality culture. Laboratories that welcome complaints as a source of genuine improvement, rather than treating them as a nuisance to be minimized, consistently identify and fix problems earlier than those that do not.
ISO 15189:2022’s complaint handling requirements formalize this welcoming, investigative posture, ensuring every complaint receives the attention it deserves — for the person who raised it, and for every future patient the resulting improvement might protect.
Learn how laboratories plan for continuity and emergencies 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.
