Laboratories and ISO 15189

ISO 15189 sets out the quality and competence requirements for medical laboratories (2022 edition; in Italy it is adopted as UNI EN ISO 15189:2024). It concerns examinations on samples of human origin for prevention, diagnosis, prognosis and therapy monitoring, and can include sample collection and point-of-care testing (POCT).

Not every laboratory automatically falls within accreditation: for an individual laboratory, for example in immunohaematology, immunogenetics or HLA, or in a transplant or ART centre, applicability depends on the activities carried out and on national and regional rules, and has to be checked case by case. In Italy accreditation is granted by Accredia, not by ICMED.

• Directors and quality managers of analysis, immunohaematology and immunogenetics laboratories
• Laboratories of transfusion services, transplant centres and ART centres assessing accreditation for their laboratory activities
• Laboratories preparing for a first accreditation or a surveillance assessment

• Staff competence and impartiality to be demonstrated with evidence
• Verification and validation of examination methods
• Internal quality control and participation in external quality assessment
• Management of risks, non-conformities and improvement
• Control of documents and records

• Gap analysis against the requirements of the standard
• Quality system, procedures and records
• Staff training on the requirements
• Internal audits and preparation for the accreditation body's assessment
• Management of corrective actions

1. Assessment — gap analysis of the laboratory against the standard
2. Work plan — priorities, responsibilities and timing
3. Implementation — procedures, records, training
4. Audit and verification — internal audits and management review
5. Maintenance — periodic audits and system updates, if requested

• Gap analysis report with an action plan
• Quality system procedures and forms
• Internal audit programme and reports
• Evidence of the training delivered

Actual content depends on the laboratory and the agreed scope.