ISO 15189:2022
Preparing Medical Laboratories for ISO 15189
ISO 15189 sets out the requirements for the quality and competence of medical laboratories — from sampling and pre-examination through to issuing results. At the centre of the standard are the reliability of results and patient safety.
What is ISO 15189:2022?
A medical laboratory is a special case: the result directly affects diagnosis and treatment, and most errors occur in the pre-examination phase — before the sample even reaches the instrument. ISO 15189 therefore covers the whole process: the physician's request, sampling, transport, testing, interpretation and reporting, including critical results.
The 2022 revision places additional emphasis on patient-risk management and is aligned with the ISO/IEC 17025 structure. We prepare biochemistry, microbiology, pathohistology and other medical laboratories for accreditation.
Implementation phases
The real phases we guide every project through — from preparation to the certificate, which comes only at the end:
Internal Audit and Assessment Preparation
Preparation follows the laboratory's process: Not sure whether you already meet these requirements? Check with the short self-assessment at the bottom of this page.
Management system and risks
Documentation, responsibilities and a patient-safety risk assessment across every phase of the work.
The pre-examination phase
Instructions for sampling, patient identification, transport and sample-acceptance criteria.
The examination phase
Method verification/validation, internal quality control and participation in external schemes (EQA).
The post-examination phase
Review, interpretation and issuing of results; handling critical values and turnaround times.
Equipment, IT and staff
Equipment maintenance and calibration, validation of the laboratory information system, staff competence.
Internal audit and assessment preparation
A complete internal review and closing findings before the accreditation body's assessment.
The path to certification
Accreditation is carried out by the national accreditation body:
The prerequisite for everything: the system is implemented and applied in practice — every requirement of the standard met, the internal audit carried out and the management review completed.
Defining the tests within the scope of accreditation and submitting documentation.
Assessors and technical experts check the system and observe how tests are performed.
Closing nonconformities within the deadlines, with our support.
Surveillance assessments through the accreditation cycle.
Benefits of Adopting the Standard
A controlled process reduces pre-examination and examination errors with real clinical consequences.
An accredited result is internationally recognised proof of reliability.
Health funds, hospitals and international partners increasingly require accreditation.
Clear procedures, traceability and competence reduce dependence on individuals.
An illustrative, typical scenario we often hear from clients — it does not represent a specific, named client.
“Most errors did not arise in the analysis itself — they happened before it, when the sample was taken and transported. Accreditation to ISO 15189 forced us to formalise the pre-analytical phase (patient identification, transport conditions, time limits) — errors in reports have fallen to almost zero.”
— a common scenario among our clients
Related standards
ISO/IEC 17025 is the general laboratory counterpart; ISO 9001 governs the institution as a whole, and ISO 27001/GDPR protect the patient data the laboratory processes.
ISO 15189 training — from a basic understanding of the standard to internal auditor training. Delivered at your premises, online or as a combination of both.
FAQ about ISO 15189:2022
What's the difference between ISO 15189 and ISO 17025?
ISO 15189 is specialised for medical laboratories — it adds pre-examination requirements, result interpretation, critical results and patient safety that the general standard doesn't cover.
Is accreditation mandatory?
It depends on regulations and contracts with health funds; the regional trend is towards mandatory accreditation for more and more types of testing.
How long does preparation take?
Usually 6 to 12 months, depending on the scope of testing and the existing system. For large systems — over 500 employees, multiple locations or an integrated system of several standards — a project realistically runs beyond a year; we handle those clients too.
What is EQA?
External Quality Assessment — inter-laboratory schemes that demonstrate the accuracy of results; participation is mandatory for the areas within scope.
How much does ISO 15189 implementation cost?
There is no fixed price that applies to everyone — the cost depends on the organisation's field of activity, its size and number of employees, the chosen standard and the current state of the system. Send us a short description of your organisation and we will prepare a free, tailored estimate.
Standards that fit together like a honeycomb
Each standard keeps its own shape, but together they form a single solid, integrated management system (IMS) — with no gaps or overlaps. Click a hexagon to open that standard.
More about the integrated management system
An integrated management system (IMS) combines two or more ISO standards — for example ISO 15189 with ISO 9001 or ISO 14001 — into one shared framework of documentation, objectives and internal reviews, instead of each standard living in its own parallel procedure.
A single structure (the High-Level Structure — HLS) shared by every modern ISO standard. Thanks to it, the quality policy, risk management, internal audits and management review can be common to several standards at once.
Each standard on its own addresses one part of the business — quality, environment, safety, information. When an organisation introduces several of them, separate systems quickly duplicate the same documentation and the same auditors.
Less duplicated procedure work, simpler management, stronger process oversight, more efficient use of resources and easier preparation for the accreditation assessment and other audits.
ISO 15189 can be implemented on its own or as part of an integrated system — the decision depends on how many standards you're targeting and whether you're introducing them at once or gradually.
Check your organization's readiness
Answer a few questions and receive an indicative assessment of your organization's current level of readiness for ISO 15189.
This self-assessment provides an indicative readiness result only. It does not constitute certification, an official audit, or formal confirmation of compliance.
The EU, the US and other markets
ISO 15189 is the same standard wherever you certify it — what differs is the designation, the accreditation behind the certificate and what your customers ask for.
In the European Union the standard is adopted with an EN prefix, and what your buyer in the Netherlands, Germany or France looks at is not the prefix but the accreditation behind the certificate: a body accredited by a signatory of the international recognition arrangement (Global Accreditation Cooperation, formerly IAF) is recognised in other markets too. What EU partners and EU regulation expect is on the page about the EU market.
For companies with customers in the United States — supplier audits, security questionnaires and how ISO sits alongside SOC 2 — see the page about the US market.
Wherever your customer is, we run the project remotely in English — over Teams, WhatsApp or Viber, with documentation and records in English — and on site when that is easier.
Montenegro and the region: MEST EN ISO 15189:2022
When people ask about a MEST EN ISO 15189:2022 certificate (or a ISO 15189:2022 certificate), they usually mean accreditation: a medical laboratory working to this standard does not receive a certificate but accreditation from the national accreditation body — in Montenegro, the Accreditation Body of Montenegro (ATCG) — which assesses its competence for a precisely defined scope. Montenegro's national edition of the standard carries identical content to the international edition — the same requirements, the same clauses, just under a national designation — which is why both designations turn up in tenders for the same standard.
Why do the designations differ if it's the same standard?
Every member country of the European and international standardisation system adopts the same standard into its own national catalogue and adds a national prefix — in Montenegro, that's MEST. The content, structure, clauses and every requirement an auditor checks during certification remain completely identical regardless of which designation appears on the document. That's why a certificate issued under one designation fully covers the other — it isn't two standards, but one and the same, simply under two names.
Our core activity is standards implementation and rollout: we prepare your organisation so the accreditation assessment goes without surprises, and we explain terms like "ISO 15189:2022 certification" and "MEST EN ISO 15189 certificate" because that's exactly how clients search for them. What certification, accreditation, IAF and surveillance audits involve — read the Certification / ISO Certificate page, and about tender designations on the ISO Standards in Tenders page.
Montenegro is where we work from: our consultants are based in Podgorica, Budva and Bijelo Polje, documentation and training come in Montenegrin or in English, and accreditation itself is granted by the national accreditation body — not by us. We work on site in Serbia, Bosnia and Herzegovina, Croatia, North Macedonia, Albania and Kosovo as well — more about what we do in Montenegro.
Some of our references
More than 400 organisations in Montenegro and the region have gone through implementation with us — from banks and public bodies to manufacturing, IT, laboratories and hospitality.
These are only some of our clients. More about us →
Request a free consultation
We will assess the scope of work and propose a realistic plan and budget for your organisation. Call us or send an inquiry — we reply within 24 hours.