EN ISO 15189:2022 PDF

Medical laboratories - Requirements for quality and competence (ISO 15189:2022)

Название (английский):

EN ISO 15189:2022

Medical laboratories - Requirements for quality and competence (ISO 15189:2022)

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 72
Дата публикации:: 14 декабря 2022 г.
Издание:: CEN EN 15189 edition 2 version 1
ICS:: 03.120.10

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Описание (английский):

This document specifies requirements for quality and competence in medical laboratories. This document is applicable to medical laboratories in developing their management systems and assessing their competence. It is also applicable for confirming or recognizing the competence of medical laboratories by laboratory users, regulatory authorities and accreditation bodies. This document is also applicable to point-of-care testing (POCT). NOTE International, national, or regional regulations or requirements can also apply to specific topics covered in this document.

Технические детали

Технический комитет: CEN/TC 140 - In vitro diagnostic systems
SKU: EN ISO 15189:2022

Abstract

Overview

EN ISO 15189:2022 (identical to EN ISO 15189:2022 / ISO 15189:2022) specifies requirements for quality and competence in medical laboratories. It is intended for laboratories developing management systems and for assessing or recognising laboratory competence by laboratory users, regulatory authorities and accreditation bodies. The standard also explicitly covers point-of-care testing (POCT) and notes that international, national or regional regulations may additionally apply.

Key topics and technical requirements

The standard addresses both management and technical elements required to achieve reliable laboratory results and patient safety. Major topics include:

General requirements
- Impartiality and confidentiality
- Management of information and release of results
- Requirements regarding patient care and privacy
Structural and governance requirements
- Legal entity and responsibilities of the laboratory director
- Governance, authority, delegation and advisory activities
- Quality management, objectives, policies and risk management
Resource requirements
- Personnel: competence, authorization, continuing education and records
- Facilities and environment, including sample collection areas
- Equipment: selection, maintenance, acceptance, adverse incident reporting
- Calibration and metrological traceability of measurement results
- Reagents and consumables: receipt, storage, acceptance testing and inventory
- Service agreements, relationships with referral laboratories and external providers
Process requirements
- Pre‑examination: patient/lab user information, requests, primary sample collection and transport
- Examination and post‑examination activities (documentation, reporting, result interpretation)
- POCT-specific arrangements and operator agreements

Practical applications - who uses ISO 15189

ISO 15189 is used by:

Medical laboratory directors and quality managers to design and maintain a laboratory management system
Laboratory staff for role-based competence and procedural controls
Accreditation bodies and regulators for assessing and recognising laboratory competence
Healthcare organisations and clinicians to select competent diagnostic service providers
POCT programme managers to integrate point‑of‑care devices and operators into the lab quality system

Typical applications include preparing for accreditation, improving test reliability, implementing traceable calibration practices, tightening reagent and equipment controls, and ensuring consistent pre- and post-analytical processes.

Related standards and notes

Supersedes EN ISO 15189:2012 and EN ISO 22870:2016 (POCT-related content consolidated)
Developed by ISO/TC 212 (Clinical laboratory testing and in vitro diagnostic test systems) in collaboration with CEN/TC 140

Keywords: ISO 15189, medical laboratories, quality and competence, laboratory accreditation, point-of-care testing, laboratory management system, metrological traceability, equipment calibration, sample handling.

Overview

Key topics and technical requirements

The standard addresses both management and technical elements required to achieve reliable laboratory results and patient safety. Major topics include:

General requirements
- Impartiality and confidentiality
- Management of information and release of results
- Requirements regarding patient care and privacy
Structural and governance requirements
- Legal entity and responsibilities of the laboratory director
- Governance, authority, delegation and advisory activities
- Quality management, objectives, policies and risk management
Resource requirements
- Personnel: competence, authorization, continuing education and records
- Facilities and environment, including sample collection areas
- Equipment: selection, maintenance, acceptance, adverse incident reporting
- Calibration and metrological traceability of measurement results
- Reagents and consumables: receipt, storage, acceptance testing and inventory
- Service agreements, relationships with referral laboratories and external providers
Process requirements
- Pre‑examination: patient/lab user information, requests, primary sample collection and transport
- Examination and post‑examination activities (documentation, reporting, result interpretation)
- POCT-specific arrangements and operator agreements

Practical applications - who uses ISO 15189

ISO 15189 is used by:

Medical laboratory directors and quality managers to design and maintain a laboratory management system
Laboratory staff for role-based competence and procedural controls
Accreditation bodies and regulators for assessing and recognising laboratory competence
Healthcare organisations and clinicians to select competent diagnostic service providers
POCT programme managers to integrate point‑of‑care devices and operators into the lab quality system

Related standards and notes

Supersedes EN ISO 15189:2012 and EN ISO 22870:2016 (POCT-related content consolidated)
Developed by ISO/TC 212 (Clinical laboratory testing and in vitro diagnostic test systems) in collaboration with CEN/TC 140

EN ISO 15189:2022 PDF

Технические детали

Abstract

Overview

Key topics and technical requirements

Practical applications - who uses ISO 15189

Related standards and notes

Похожие стандарты

Abstract

Overview

Key topics and technical requirements

Practical applications - who uses ISO 15189

Related standards and notes

Похожие стандарты

Medical laboratories — Requirements for quality and competence

Medical laboratories — Requirements for quality and competence

Point-of-care testing (POCT) — Requirements for quality and competence

Medical laboratories — Guidance on application of ISO 15189 in anatomic pathology