Quality
ISO 15189:2022 — Quality and competence of medical laboratories
The accreditation standard for medical laboratories: examination quality in the service of the patient, from request to report.
At a glance
- Type
- International standard, accreditation standard
- Publisher
- ISO (technical committee ISO/TC 212)
- Version
- 2022 (4th edition)
- Accreditation
- Mandatory in France, granted by COFRAC (Human health section)
123 requirements tracked · 120 shared controls
What is ISO 15189?
ISO 15189 sets out the quality and competence requirements for medical laboratories, in the interest of patients. It is the standard against which national accreditation bodies assess these laboratories: in France, accreditation is a legal obligation granted by COFRAC (Human health section) on the basis of NF EN ISO 15189 and its application documents, SH REF 02 and SH REF 08.
The fourth edition (December 2022) was restructured along the lines of ISO/IEC 17025: general requirements (impartiality, confidentiality, patients), structure and governance, resources, processes and management system, with a stronger risk-based approach. It incorporates the ISO 22870 requirements on point-of-care testing into a normative Annex A, and leaves the choice between Option A, described in the standard, and Option B, based on a system conforming to ISO 9001.
What sets it apart from a testing laboratory standard: the place of the patient (information, consent, reception, access to results), the pre-examination phase from collection to receipt, reference intervals and clinical decision limits, immediate communication of critical results, IVD vigilance and the oversight of examinations performed at the bedside by clinical staff.
Key requirements
- 1
Impartiality, confidentiality and patients
Control risks to impartiality, protect patient information and organise the service around patients: information, consent, reception and privacy at collection, respect for individuals, access to results.
- 2
Governance and risk management
A legally responsible entity, a competent laboratory director with defined responsibilities, a clear organisation, measured objectives and a risk management process covering patients, staff and operations.
- 3
Resources: personnel, facilities, equipment, reagents
Defined and assessed competence with formal authorisations; controlled premises and collection sites; equipment accepted, maintained and calibrated with metrological traceability; reagents and consumables verified at each lot and tracked in inventory; incidents reported to the manufacturer and the authorities.
- 4
Pre-examination phase
Information for patients and requesters, request content, collection instructions, positive patient identification, transport, acceptance criteria on receipt and sample stability.
- 5
Examination phase
Verify commercial methods and validate developed or modified methods, evaluate measurement uncertainty, justify reference intervals, document procedures and assure the validity of results through internal quality control, external quality assessment and comparability between sites.
- 6
Post-examination phase and continuity
Review and release results, communicate critical results immediately, govern automated release, amend reports already issued, control the information system and its downtime plans, handle nonconforming work and complaints, prepare for emergencies.
- 7
Management system and point-of-care testing
Keep the system alive (Option A or B): documents, records, risks and opportunities, quality indicators, internal audits, management review; and, for point-of-care testing, governance, a quality assurance programme and operator training under the laboratory’s responsibility.
Summary written by OK-GRC. The texts of ISO standards are protected by copyright and are not reproduced.
How OK-GRC helps
- The 123 requirements of clauses 4 to 8 and Annex A mapped to 120 shared controls, including 6 controls specific to medical laboratories (patients and collection, critical results, reference intervals, point-of-care testing, reagents, IVD vigilance) and 19 technical controls shared with ISO/IEC 17025
- Options A and B tracked as requirements: the option not chosen is excluded with its justification, without distorting the score
- An implementation programme in the Programmes module (ISO management system methodology), with milestones, deliverables and an action plan towards the accreditation assessment
- Dated evidence (calibration certificates, external quality assessment results, authorisations, lot verifications) with reminders before expiry
- Internal audits, management review, nonconforming work, complaints and corrective actions linked to the requirements
- An assistant that knows the standard, the French accreditation requirements and the laboratory vocabulary, to draft procedures and answers to findings
Related frameworks
With ISO 27001 controls in place, your ISO 15189 starting score is about 33 to 36%.
With an ISO 9001 quality management system in place, your ISO 15189 starting score is about 35 to 43%.
The controls you put in place for ISO 15189 also count for:
- ISO/IEC 17025Same structure and same technical controls: a laboratory already organised under ISO/IEC 17025 covers 114 to 120 of the 123 ISO 15189 requirements (starting score of about 59 to 80%). What remains are the requirements specific to medical laboratories.
- ISO 9001Option B: an ISO 9001 QMS already covers, at least in part, 23 to 26 of the 26 requirements of clause 8 (starting score of about 71 to 78% on this clause). Clauses 6 and 7 and Annex A remain to be built.
- ISO 27001Confidentiality of patient information (4.2) and control of the laboratory’s data and information system (7.6) rely on your information security controls.
- GDPRExamination results are health data: consent, patient information, access rights and record retention also fall under the GDPR.
Frequently asked questions about ISO 15189
Is ISO 15189 accreditation mandatory?
In France, yes: the Public Health Code requires medical laboratories to be accredited for all their activities, by COFRAC on the basis of NF EN ISO 15189 and its application documents (SH REF 02, SH REF 08). In other countries, accreditation remains voluntary but is often required by payers or health authorities. OK-GRC prepares the assessment; only the accreditation body grants, maintains, extends or suspends an accreditation.
What changes with the 2022 edition?
The structure now follows ISO/IEC 17025:2017 (clauses 4 to 8), risk management for patients runs through the whole standard, patient-related requirements are grouped together, and point-of-care testing, previously covered by ISO 22870, is integrated into a normative Annex A. In France, COFRAC’s transition to the 2022 edition has been complete since December 2025. Check with your accreditation body for the current revisions of its application documents.
We are already ISO 9001 certified: what is left to do?
Your QMS can serve as the foundation (Option B): it covers at least in part 23 to 26 of the 26 requirements of clause 8. Over the whole standard, the starting score remains about 35 to 43%: most of the work concerns the pre-examination phase, competence and authorisations, equipment and reagents, method verification and validation, internal quality control and external quality assessment, critical results and point-of-care testing.
ISO 15189 or ISO/IEC 17025: which one applies to my laboratory?
ISO 15189 is for laboratories that examine samples of human origin for diagnosis, monitoring or prevention; ISO/IEC 17025 is for testing and calibration laboratories (chemistry, environment, materials, metrology). A laboratory carrying out both types of activity can be accredited to both standards; OK-GRC maps their requirements to the same technical controls so the work is not done twice.
Informational content up to date as of October 2026; it does not constitute legal advice. Always check the official texts in force.
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