ISO-15189 › Medical laboratories - Requirements for quality and competence
Document Center Inc. is an authorized dealer of ISO standards.
The following bibliographic material is provided to assist you with your purchasing decision:
The following bibliographic material is provided to assist you with your purchasing decision:
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)
This document comes with our free Notification Service, good for the life of the document.
This document is available in either Paper or PDF format.
Customers who bought this document also bought:
ASTM-D4169Standard Practice for Performance Testing of Shipping Containers and Systems
BS-EN-ISO-13485
Medical devices. Quality management systems. Requirements for regulatory purposes
ISO-13485
Medical devices - Quality management systems - Requirements for regulatory purposes
Document Number
ISO 15189:2022
Revision Level
4TH EDITION
Status
Current
Publication Date
Dec. 1, 2022
Committee Number
ISO/TC 212