The standard that accredits a medical laboratory's technical competence within the healthcare system. Administrative authorisation lets a laboratory open; ENAC accreditation demonstrates that its results are reliable.
ISO 15189 is the international standard setting out particular requirements for quality and competence in medical laboratories: those that examine human biological samples to provide information for the diagnosis, prognosis, treatment and monitoring of a patient. In Spain, accreditation under this standard is granted by ENAC (Entidad Nacional de Acreditación), designated as the sole national accreditation body by Spanish Royal Decree 1715/2010, implementing Regulation (EC) No 765/2008. ENAC works with 13 medical scientific societies to bring the technical criteria of each laboratory specialty into the assessment.
Accreditation is voluntary and distinct from healthcare authorisation. Every medical laboratory needs administrative authorisation from its region to operate, under Spanish Royal Decree 1277/2003, which regulates the U.73 care unit (Laboratorio Clínico). That authorisation certifies that the laboratory meets minimum conditions for premises and staff. ENAC accreditation is a further, voluntary step: it demonstrates, through independent technical assessment, that the results the laboratory issues are technically reliable and comparable with those of any other accredited laboratory worldwide, thanks to ILAC's mutual recognition arrangements.
The current edition is ISO 15189:2022, published in December 2022, which replaced the 2012 edition with a more outcomes-focused, less prescriptive approach, without lowering the bar. The most significant change for the sector was integrating into a single text the requirements that ISO 22870 previously regulated separately for point-of-care testing (POCT), tests carried out at the patient's side rather than in the central laboratory. ILAC set a three-year transition period that ended in December 2025: from that date, accreditations under the 2012 edition, and POCT accreditations under ISO 22870:2016, are no longer internationally recognised. Since then, 2012-edition accreditations are no longer recognised under the ILAC arrangement.
The sector is also going through a parallel professional reorganisation. Spanish Royal Decree 101/2025, in force since 20 February 2025, replaced the separate specialties of Clinical Analysis and Clinical Biochemistry with a single Laboratorio Clínico specialist qualification, and Royal Decree 239/2026 went on to update the care units under Royal Decree 1277/2003. The regulatory trend runs in the same direction as ISO 15189: a single medical laboratory integrating disciplines that were previously separate.
At Summum Calidad we support medical laboratories, public and private, hospital-based and independent, from the gap analysis through to the ENAC assessment: we design the management system, the method validation plan, the quality assurance of results and, where applicable, the POCT scope. We are consultants, not an accreditation body: it is always ENAC that grants accreditation, independently.
The standard organises its requirements into two broad blocks: management requirements, common to any quality system, and technical requirements, specific to the medical laboratory. The 2022 edition also adds, integrated into the same text, the requirements block for point-of-care testing (POCT), previously regulated separately by ISO 22870. The approach is more outcomes-focused than the 2012 edition: it requires demonstrating that the system works, not merely that the procedure exists.
| Requirements block | What it requires | Evidence requested |
|---|---|---|
| Impartiality and confidentiality | That no commercial or administrative interest influences a result, and that patient data is handled with clinical confidentiality. | Signed policy, impartiality risk analysis, staff confidentiality agreements. |
| Structure and responsibilities | A clear organisational chart, with a laboratory director and defined technical leads per unit. | Organisational chart, job descriptions, formal appointments. |
| Personnel | Qualification, ongoing training and competence assessment for whoever signs or interprets a result. | Personnel files, training records, periodic competence assessments. |
| Facilities and environmental conditions | Space, temperature, humidity and biosafety suited to each analytical technique. | Environmental monitoring records, floor plans, biosafety protocols. |
| Equipment, reagents and traceability | Calibrated and maintained equipment, batch-traceable reagents, and controlled replacement of critical material. | Equipment records, calibration certificates, batch control. |
| Pre-examination/examination/post-examination process | Unambiguous identification of patient and sample, analytical validation and correct reporting of results. | Procedures per phase, sample nonconformity records, validation protocols. |
| Quality assurance of results | Systematic internal quality control and participation in external quality assessment schemes. | Control charts, interlaboratory comparison reports, deviation (z-score) monitoring. |
| Point-of-care testing (POCT) | Management of tests performed at the patient's side, outside the central laboratory, with the same analytical rigour. | Training of non-laboratory operators, quality control of POCT devices, connectivity with the information system. |
Confusing the two procedures is common and costs time. Healthcare authorisation is granted by the region where the laboratory operates, under Royal Decree 1277/2003, which sets out the general basis for authorising healthcare centres, services and establishments. The medical laboratory is registered as care unit U.73, and without that authorisation it cannot open or operate, regardless of its technical level.
ENAC accreditation under ISO 15189 is a separate, voluntary step, taken after authorisation. It does not replace healthcare authorisation: it adds an independent technical competence assessment that administrative authorisation does not cover. A laboratory can be perfectly authorised and operating without ever being accredited; accreditation is what allows its results, for instance, to be accepted without repeating the analysis in another country party to the ILAC arrangements.
Point-of-care tests (POCT) are carried out at the patient's side (on a hospital ward, in the emergency department, in a consultation room) instead of in the central laboratory: blood gas analysis, glucose testing, rapid coagulation or cardiac marker tests. Until the 2012 edition, their accreditation was regulated by a separate standard, ISO 22870, always alongside ISO 15189.
The ISO 15189:2022 edition integrated those requirements into a single text. ILAC set a three-year transition period from the standard's publication date, which ended in December 2025: from that date, POCT accreditations under ISO 22870:2016 are no longer recognised independently under the ILAC arrangement. A laboratory with active POCT units must now manage them within the same ISO 15189:2022 accreditation scope, with training for non-laboratory personnel and quality control of the devices being the most demanding points in practice.
The ISO 15189 accreditation scheme is open to any medical laboratory, public or private, regardless of size: from the central laboratory of a reference hospital to an independent laboratory attached to a private medical practice. There is no minimum threshold for activity or staff numbers.
What decides the project's viability is the maturity of the starting quality control system (whether it already takes part in external assessment schemes, whether it has a track record of method validation) and the clarity of the scope applied for: how many units (biochemistry, haematology, microbiology, immunology, genetics) and how many techniques within each. Accrediting the whole analytical catalogue at once is rarely the best strategy; starting with the highest-volume or highest clinical-impact techniques and extending the scope afterwards usually gives better results in the first assessment cycle.
We assess the laboratory against ISO 15189:2022: quality management, staff, premises, equipment, pre-examination/examination/post-examination processes and, where applicable, POCT. From this we build a gap map ordered by priority for closure.
We draft the quality manual, the technical and management procedures, and support the validation or verification of analytical methods, the estimation of uncertainty and the declared reference intervals.
We support medical and technical staff in applying the system: internal quality control, interlaboratory comparisons, reagent and equipment traceability. We carry out a full internal audit before calling in ENAC.
We organise the documentation and rehearse the ENAC visit with a dry run, and close any nonconformities that arise. After accreditation, we support surveillance visits and scope extensions to new techniques or POCT units.
The operational detail: what we deliver as part of the work and what we keep alive afterwards.
Quality manual and procedures
Management system documentation: manual, technical procedures by unit (biochemistry, haematology, microbiology, immunology) and support procedures.
Method validation and verification
Analytical validation protocol, measurement uncertainty calculation and reference intervals adapted to the population served.
Quality control and interlaboratory comparison plan
Daily internal quality control, participation in external quality assessment schemes and follow-up of out-of-range results.
Equipment and reagent traceability
Equipment inventory, maintenance and calibration schedule, and batch control of reagents and reference material.
Point-of-care testing (POCT) scope
Design of the management system for tests carried out at the patient's side, integrated into the same accreditation scope since the 2022 edition.
ENAC assessment dry run
Internal assessment using ENAC's protocol: documentary review, interviews with medical and technical staff, and live observation of processes.
Normas y reglamentos verificados que aplican a este servicio: Spanish Royal Decree 1277/2003, of 10 October, Spanish Royal Decree 101/2025, of 18 February, Regulation (EC) No 765/2008 and Spanish Royal Decree 1715/2010….
An accredited medical laboratory handles health data, a special category under the GDPR, and is often part of a group that also needs to accredit non-clinical testing under ISO/IEC 17025.
When the laboratory also runs tests outside the clinical field (water, food), it needs ISO/IEC 17025 testing laboratory accreditation, with equivalent but distinct technical requirements.
View service → calidadIf the laboratory manufactures or validates in vitro diagnostic reagents or equipment, it also needs the ISO 13485 medical device management system.
View service → consultoríaClinical data is a special category under the GDPR. Summum Consultoría implements the measures and the data protection officer that handling medical records and test results requires.
View service →It is the recognition, granted by ENAC, that a medical laboratory is technically competent for the scope of tests it applies for. ENAC is the sole national accreditation body in Spain. Summum Calidad does not grant accreditation: our role is to support the process; the decision, made independently, always rests with ENAC.
No. Healthcare authorisation is granted by the region under Royal Decree 1277/2003 and is mandatory to operate: it certifies minimum conditions for premises and staff. ENAC accreditation under ISO 15189 is voluntary and comes afterwards: it assesses the laboratory's technical competence and the reliability of its results, with international recognition through ILAC.
It adopted a more outcomes-focused approach, with less prescription about the “how”. The most significant change was integrating the requirements for point-of-care testing (POCT), previously regulated by ISO 22870, into the same text. The transition period set by ILAC ended in December 2025; since then, only accreditations under the 2022 edition are recognised.
Yes. The accreditation scheme is open to any medical laboratory, public or private, regardless of size. What matters is demonstrating technical competence for the scope applied for, not test volume. Summum Calidad sizes the documentary system to the real laboratory, not to a theoretical model designed for a large hospital.
Before 2022, yes: they were accredited under ISO 22870, alongside ISO 15189:2012. Since the 2022 edition, POCT requirements form part of the same standard and the same accreditation scope as the medical laboratory, although they are still assessed against their own criteria because of their use outside the central laboratory.
In our experience, a typical project takes around 12 to 18 months from the initial gap analysis through to the award, depending on the number of techniques and units included in the scope and the starting state of the documentary system. Laboratories with a solid track record of internal quality control and participation in external comparisons can complete it sooner.
ISO 9001 is a generic quality management system that demonstrates controlled processes, but it does not validate the laboratory's technical competence. ISO 15189 also requires validating analytical methods, estimating uncertainty, taking part in external assessment schemes and demonstrating the reliability of every result issued, with clinical interpretation as the ultimate criterion.
No. Summum Calidad is a consultancy: we design the system, support method validation and prepare the assessment, but it is ENAC that decides, always independently. We never anticipate or guarantee the outcome of its assessment.