EN ISO 15189 is an international standard setting out the quality and competence requirements specific to medical laboratories.
Its stated purpose is to improve patient care and ensure the satisfaction of laboratory users, through confidence in the quality and competence of the laboratory.
The standard defines the organisational and management requirements placed on medical laboratories. It covers the full testing cycle — pre-analytical, analytical and post-analytical — and sits within a quality management and continual improvement approach.
EN ISO 15189 makes patient satisfaction an explicit objective of the laboratory's quality system, and requires structured arrangements for collecting, handling and acting on feedback.
EN ISO 15189: the quality framework for medical laboratories
A standard written for medical laboratories
EN ISO 15189 targets medical biology laboratories specifically, and medical laboratories more broadly.
It covers both technical competence and the organisation of the quality system, with one clear aim: to guarantee the reliability of results and the safety of patient care.
In France, the standard is the basis for laboratory accreditation by COFRAC. Beyond the regulatory obligation, it has become a marker of trust for patients and for the wider healthcare ecosystem.
A whole-journey view of quality, from sample to report
EN ISO 15189 covers the entire patient journey through the laboratory, from the request and the sample through to interpreting and reporting results. Every step is a link in the quality chain, with its own risks, requirements and opportunities for improvement.
On that basis, the standard asks laboratories to put a genuine quality management system in place:
- process mapping
- indicators
- non-conformity management
- risk analysis
- internal audits
- management reviews
The satisfaction of the laboratory's "users" — patients, requesting clinicians, care providers and others — belongs inside that framework: their feedback becomes data in its own right.
ISO 15189 and the satisfaction of patients and users
Satisfaction as an explicit objective of the quality system
Read with practical eyes, ISO 15189 treats patient satisfaction as an expected outcome of the quality system. The text places the satisfaction of patients and users at the heart of the management system, alongside the quality of care and the medical service itself.
The standard makes clear that the purpose of a laboratory is not only to produce accurate results, but to deliver a service that meets the needs and expectations of patients.
Laboratories are expected to organise the monitoring and handling of complaints — from patients, requesting clinicians and partners — with documented corrective actions.
In concrete terms, the standard requires laboratories to seek out, collect, analyse and act on feedback from patients, users and staff, in order to improve the management system, the activities and the services.
Complaints, feedback and continual improvement: clearly framed requirements
ISO 15189 frames complaint handling. The laboratory must have a formal arrangement for collecting complaints and comments, recording them, analysing them and implementing corrective or preventive actions.
Beyond complaints, the standard stresses the need to actively seek user feedback: patients, requesting clinicians and partner organisations, but internal staff as well.
In practice, that means putting suitable collection channels in place and making sure the information feeds back into the quality management system.
That field feedback has to nourish continual improvement. This is where a structured approach to managing satisfaction earns its place.
From compliance to opportunity: why build a real feedback strategy?
Burden of proof: showing that satisfaction is taken into account
In an accreditation process, a laboratory has to provide evidence that it actively listens to its users. That means showing how feedback is collected, recorded, analysed and then turned into action.
Yet as soon as the volume of feedback grows, informal arrangements — emails, a notebook at the desk, paper forms — start to show their limits:
- scattered information
- incomplete follow-up
- difficulty producing reliable indicators
Formalising how satisfaction is collected and managed then becomes the way to secure the evidence base — and to gain efficiency along the way.
Making the patient voice a genuine quality indicator
Moving from a reactive stance — answering complaints as they arrive — to a proactive one — measuring satisfaction regularly and tracking indicators — changes the place the patient voice holds in the laboratory.
Satisfaction becomes a quality indicator in its own right, on the same footing as turnaround times, the non-conformity rate or technical incidents.
In practice, that can mean post-visit surveys, targeted questionnaires on the stages that matter — reception, sampling, issuing results, interpretation — or structured analysis of complaints and verbatim comments to surface recurring pain points.
These data make it possible to prioritise improvement work and to assess, with figures to hand, the impact of the actions taken on the patient experience.
How a satisfaction management platform supports the ISO 15189 requirements
Structuring the collection of patient feedback
To meet what ISO 15189 expects, the first step is to move away from feedback gathered as it happens, towards systematic collection.
A satisfaction management platform automates the sending of surveys after the key moments of the journey, and centralises the responses.
That centralisation makes the data usable. The laboratory has a single, historised base, which lets it demonstrate at audit that it actively seeks user feedback and can evidence how that feedback is taken into account.
Turning feedback into indicators and action plans
A dedicated tool turns those data into indicators that read clearly, for management and for front-line teams alike: satisfaction scores, NPS, how often each theme comes up, the volume and type of complaints, handling times, and so on.
These KPIs enrich the quality dashboard. More importantly, every signal can be tied to an action plan:
- improving reception
- clarifying sampling instructions
- adjusting opening hours
- better information on turnaround times
- …
Tracking over time shows the concrete impact of the decisions taken, puts numbers on the progress made, and documents the corrective and preventive actions expected in an ISO 15189 approach.
Supporting management reviews and embedding a culture of improvement
In a management review, having clear dashboards changes the nature of the discussion. Satisfaction is steered on the basis of figures and consolidated analysis. It then becomes far easier to prioritise the topics to address and to set quality objectives that everyone shares.
Finally, a management platform makes the approach tangible for the teams: each department can:
- see its own results
- understand what patients and requesting clinicians expect
- watch the effect of its efforts over time
ISO 15189 then stops being seen as a purely regulatory frame, and becomes a lever serving the patient experience and the overall performance of the laboratory.
You want to meet the ISO 15189 requirements and turn listening to patients into a quality improvement lever for your laboratory.
Talk to our team to discuss your needs and set up your satisfaction management programme.
Image source: canva
- Topics
- Satisfaction Client
.png)
