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ISO 15189 — Clinical laboratories
ISO 15189's five sections, with the pre-examination, examination and post-examination phases and result assurance explained step by step.
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- 1 General requirements How to protect the confidentiality of clinical data and guarantee the lab's impartiality. Section 1
- 2 Resource requirements How to manage staff, facilities and equipment with clinical metrological traceability. Section 2
- 3 Process requirements How to control the pre-examination, examination and post-examination phases. Section 3
- 4 Ensuring the validity of results How to demonstrate the lab's clinical results are reliable. Section 4
- 5 Management system requirements How to document the system, run internal audits and hold management review. Section 5
Every section of ISO 15189, explained
ISO 15189 organizes its requirements into general, resource, process, result-quality-assurance and management system requirements, with the patient as a constant focus.
This path explains each section with sample traceability, critical value communication and the evidence an accreditation body usually asks for.
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Sources
Where each figure comes from
References to the official text in force. If a standard is revised, this page is updated and the review date says so.
- ISO 15189:2022 — Medical laboratories. Requirements for quality and competence ISO · December 2022
- ISO/IEC 17025:2017 — Competence of testing and calibration laboratories ISO/IEC · November 2017
- Entidad Nacional de Acreditacion ENAC · Official portal