SS-EN-ISO-15189 › Medical laboratories - Requirements for quality and competence (ISO 15189:2022)
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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). NOTE International, national, or regional regulations or requirements can also apply to specific topics covered in this document.
To find similar documents by classification:
03.120.10 (Quality management and quality assurance)
11.100.01 (Laboratory medicine in general)
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Designation Name
SS-EN ISO 15189:2022
Revision Level
2022 EDITION
Status
Current
Publication Date
Dec. 19, 2022
Language(s)
English
Page Count
76
International Equivalent
EN ISO 15189:2022(IDT); ISO 15189:2022(IDT)