SIST EN ISO 15189:2013/AC101:2015
(Corrigendum)Medical laboratories - Requirements for quality and competence (ISO 15189:2012)
Medical laboratories - Requirements for quality and competence (ISO 15189:2012)
Medizinische Laboratorien - Anforderungen an die Qualität und Kompetenz (ISO 15189:2012)
Medicinski laboratoriji - Zahteve za kakovost in kompetentnost (ISO 15189:2012) - Popravek AC101
General Information
Standards Content (Sample)
pilsbkphI pTAkaAoa
pIpT bk Ipl kok89:ljkmiACkjk
april ljko
jedicinski laboratoriji – Zahteve za kakovost in kompetentnost
bIpl kok89:ljkl) – mopravek ACkjk
jedical laboratories – oequirements for quality and competence
(fpl kok89:ljkl)
iaboratoires d'analyses de biologie médicale – bxigences concernant la qualité et la compétence (fpl kok89:ljkl)
jedizinische iaboratorien – Anforderungen an
...
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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).
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- the technical risk management including the definition of safety/security goals and the workflow organization as well as the necessary specifications regarding a technical risk management file;
- associated duties, responsibilities and activities as parts of an integrated overall risk management process to achieve the safety and security goals, effectiveness and efficiency as well as data and system safety/security;
- three different grades of safety/security, with the respective product functionalities required to achieve them;
- the basic requirements for emergency and danger response systems (EDRS) in public buildings such as education facilities (e.g. schools, universities), government facilities, kindergartens and similar facilities;
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- the process of establishing, maintaining and updating a risk management file in which, inter alia, the technical risks are listed and evaluated and the residual technical risks are defined, resulting in the grade and structure of the EDRS;
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- fire safety systems including, but not limited to, fire detection and fire alarm systems, fixed firefighting systems, smoke and heat control systems,
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