ISO 15189:2022 CLAUSE GUIDE
ISO 15189:2022 clause guide for medical laboratories
Practical, plain-language explanations of the 35 clauses medical laboratories most often need to document — what each is about, what assessors usually look for, and which SOPs, forms and records provide evidence.
Check the exact requirement in your licensed copy of the standard.
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How the standard is organised
ISO 15189:2022 places its requirements in sections 4 to 8. Sections 1–3 set out scope, references and terms; the annexes add topics such as point-of-care testing. The overview below is our own summary.
- Section 4 · General requirementsImpartiality, confidentiality and the laboratory's obligations to patients — the ethical base the rest of the system sits on.
- Section 5 · Structural and governance requirementsWho the laboratory is and how it is run: legal identity, the director's responsibilities, scope, organisation, objectives and risk management.
- Section 6 · Resource requirementsThe resources needed to deliver reliable results: people, premises, equipment, calibration, reagents, agreements and suppliers.
- Section 7 · Process requirementsThe patient pathway from request to report: pre-examination, examination, assuring result validity, reporting, nonconforming work, data and complaints.
- Section 8 · Management system requirementsThe management system that keeps everything controlled and improving: documents, records, risks, corrective action, audits and management review.
- AnnexesAdditional guidance, including point-of-care testing, which applies when the laboratory oversees testing outside its own premises.
Find a clause
Section 4 · General requirements
Section 5 · Structural and governance requirements
Section 6 · Resource requirements
Section 7 · Process requirements
- 7.2 Pre-examination processes
- 7.3 Examination processes
- 7.3.2 Verification of examination methods
- 7.3.3 Validation of examination methods
- 7.3.4 Evaluation of measurement uncertainty
- 7.3.5 Biological reference intervals and clinical decision limits
- 7.3.7 Ensuring validity of examination results
- 7.4 Post-examination processes
- 7.5 Nonconforming work
- 7.6 Control of data and information management
- 7.7 Complaints
- 7.8 Continuity and emergency preparedness planning
Section 8 · Management system requirements
Put it into practice
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