The standard your NHS and insurer contracts assume you hold. We build the quality management system, get the evidence in order, and prepare your laboratory for assessment.
ISO 15189:2022 is the international standard for medical laboratories – Requirements for quality and competence. Unlike a pure management-system standard, it assesses both how you run the laboratory and whether your testing is technically sound.
The governance layer: document and record control, nonconformity and corrective action, internal audit, management review, risk management, impartiality and confidentiality, and continual improvement.
Where laboratories most often fall short. Method validation and verification, measurement uncertainty, equipment calibration and maintenance, reagent control, and demonstrable staff competency for each procedure.
ISO 15189 follows the sample, not just the bench. Pre-examination through to reporting and clinical advice – including point-of-care testing, now folded into the 2022 version.
For a laboratory starting without an established quality management system, twelve to eighteen months is realistic. Extending an existing accredited scope is considerably faster.
An honest assessment of the laboratory against ISO 15189:2022, clause by clause, with a prioritised action plan and a defensible timeline. This is also where we tell you if accreditation is premature – a laboratory without settled methods or sufficient staffing is not ready to start, and beginning anyway wastes a year.
The documented system built to how your laboratory actually operates: quality manual, standard operating procedures, document and record control, nonconformity handling, internal audit programme and management review. Written so that the staff running the bench can follow it, which is what assessors test.
UKAS assesses a working laboratory, not a folder. Method validation and verification files, competency assessment for every procedure, equipment calibration and maintenance records, external quality assessment participation and performance, and a completed cycle of internal audit and management review. This phase sets the timeline more than any other.
Mock assessment against the scope you are applying for, evidence pack review, and preparation of your staff for technical assessor questioning. We support you through the assessment itself and through closing any findings raised, then help keep the accredited scope current as your repertoire changes.
A laboratory service in England will usually need CQC registration for the regulated activity of diagnostic and screening procedures, alongside UKAS accreditation. These are separate obligations with substantially shared evidence.
CQC registration is a legal requirement to carry on a regulated activity. ISO 15189 accreditation demonstrates technical competence and quality, and is typically a contractual or commercial gate rather than a statutory one. You can hold one without the other, and many labs discover the gap late.
Governance structure, document control, competency and training records, incident and nonconformity handling, and audit all serve both. Built once and mapped to both frameworks, the second programme costs a fraction of the first.
We run CQC registration and ISO 15189 preparation as a single programme where both apply, rather than two consultancies producing two sets of documents that contradict each other in front of an assessor.
| Full title | ISO 15189 – Medical laboratories: requirements for quality and competence. |
|---|---|
| Current version | ISO 15189:2022, which replaced ISO 15189:2012 and absorbed point-of-care testing from ISO 22870. |
| Accreditation body | UKAS, the United Kingdom Accreditation Service – the UK's national accreditation body. |
| What it covers | Both the quality management system and technical competence, across pre-examination, examination and post-examination phases. |
| Who typically needs it | NHS pathology, private pathology and diagnostic laboratories, laboratories serving NHS or insurer contracts, and laboratories supporting private clinics and direct-to-consumer testing. |
| Statutory or contractual | Usually contractual or commercial rather than a legal requirement – but frequently a hard gate on the contracts that matter. |
| Typical timeline | 12–18 months from kick-off for a laboratory with no established quality management system. Faster when extending an existing accredited scope. |
| Nature of accreditation | Granted for a defined scope of tests and maintained through an ongoing UKAS surveillance and reassessment cycle. |
| Related CQC obligation | Laboratory services in England usually require CQC registration for diagnostic and screening procedures. |
The international standard for medical laboratories, titled Medical laboratories – Requirements for quality and competence. It covers both the quality management system and the technical competence of the laboratory, across the pre-examination, examination and post-examination phases. The current version is ISO 15189:2022, which replaced ISO 15189:2012.
UKAS – the United Kingdom Accreditation Service – is the UK's national accreditation body, appointed by government. It assesses medical laboratories against ISO 15189 and grants accreditation for a defined scope of tests.
Accreditation is not a one-off certificate. UKAS reassesses on an ongoing surveillance cycle, and the accredited scope must be kept current as your test repertoire changes. Adding a test you are not accredited for, and reporting it as accredited, is a serious finding.
It is the expected standard for UK medical laboratories: NHS pathology, private pathology and diagnostic laboratories, laboratories serving NHS contracts, and laboratories supporting private clinics and direct-to-consumer testing services. NHS and insurer contracts commonly require it, so in practice it is a commercial gate more often than a legal one.
The standard was restructured and aligned more closely with ISO/IEC 17025. The substantive shifts: a stronger emphasis on risk management and opportunities for improvement, greater focus on patient and user needs, revised requirements on impartiality and confidentiality, and the incorporation of point-of-care testing, previously covered by the separate ISO 22870. Laboratories accredited to the 2012 version were required to transition.
Twelve to eighteen months from kick-off for a laboratory starting without an established quality management system. The system has to be built, staff trained and competency-assessed, methods validated or verified, and a period of live operating records generated before UKAS will assess. UKAS scheduling and closing any findings then add further time.
Extending an existing accredited scope is considerably faster.
Separate obligations that usually apply to the same organisation. CQC registration is the legal requirement to carry on a regulated activity in England – for a laboratory, normally diagnostic and screening procedures. ISO 15189 accreditation demonstrates technical competence and is typically contractual.
The governance, document control, competency and audit evidence overlaps substantially, so running both as one programme is materially cheaper than running them separately.
A UKAS team including technical assessors with expertise in your discipline reviews your documented system, then assesses on site. They observe testing, examine records, trace samples through the whole pathway, review validation and verification data, interview staff about competency, and examine internal audit, external quality assessment performance and management review.
Findings are raised for you to address before accreditation is granted or maintained.
General information about ISO 15189 and UKAS accreditation, not advice on a specific laboratory. Standards and accreditation requirements change – check the current position with UKAS or take advice on your own circumstances.
