Guide
ISO 15189 — in brief
ISO 15189 is the international standard setting out requirements for quality and competence in medical laboratories. Laboratories are accredited against it — in Bulgaria by the Executive Agency “Bulgarian Accreditation Service”. Accreditation shows that the results are technically valid and that the laboratory manages its quality systematically.
The current version is ISO 15189:2022. It also includes the requirements for point-of-care testing (POCT), which were previously in the separate standard ISO 22870. The three-year transition period ended in December 2025.
Who is ISO 15189 for
The standard is for all laboratories that examine samples from patients:
- Clinical and medical diagnostic laboratories
- Microbiology and virology laboratories
- Clinical pathology and cytology laboratories
- Immunology and genetics laboratories
- Hospital laboratories and point-of-care testing
- Transfusion haematology laboratories
What ISO 15189 requires
The standard covers the entire path of the sample: before the examination — the request, collection, transport and receipt of the sample; during the examination — validated or verified methods, internal quality control and participation in external quality assessment; after the examination — review and release of the result. Many errors happen as early as sample collection, which is why the right result starts with the right tube.
Also required are competent staff, a suitable environment and equipment, evaluation of measurement uncertainty, risk management, confidentiality of patient data, and a management system that is audited and improved. An accurate result has two enemies: systematic error, which shifts all results in one direction, and random error, which scatters them. The standard requires the laboratory to know both — through internal quality control, external quality assessment and evaluation of measurement uncertainty.
The benefits
For doctors and patients, accreditation means trust: the result has been obtained with a verified method, by competent staff and under control. For the laboratory, it is an advantage in contracts with healthcare institutions and other clients.
Working to the standard also brings order inside the laboratory — fewer errors before the examination, clearer responsibilities, better tracking of equipment and reagents, and data on which management can base its decisions. The assessment itself is carried out by the accreditation body; Baltov Consult prepares the laboratory for it.
How implementation works
- Gap analysisWe compare the laboratory’s practices and documents with the requirements of ISO 15189:2022.
- Processes and documentsA manual, procedures for the stages before, during and after the examination, and records.
- Methods and controlValidation or verification of methods, internal quality control and external quality assessment.
- Uncertainty and riskEvaluation of measurement uncertainty and management of risks to the patient.
- Training and internal auditStaff training and an internal audit of the system and of technical competence.
- Accreditation assessmentPreparation of the documents and support during the assessment by the accreditation body.
What you get
- An ISO 15189:2022 manual and procedures
- Rules for sample collection and receipt
- Validated or verified methods
- A plan for internal quality control and external quality assessment
- An evaluation of measurement uncertainty
- A risk register
- Trained staff and internal auditors
- Documents for the accreditation application