[Development and Current Status of Quality Management Systems for Specimen Examination].

Title[Development and Current Status of Quality Management Systems for Specimen Examination].
Publication TypeJournal Article
Year of Publication2015
AuthorsKanemura, S
JournalRinsho Byori
Volume63
Issue7
Pagination808-15
Date Published2015 Jul
Publication Languagejpn
ISSN0047-1860
Abstract

ISO 15189:2003 was published as an International Standard in 2003 by Technical Committee ISO/TC212 of the International Organization for Standardization (ISO). This international standard based on ISO 9001 specifies requirements for competence and quality that are specific to medical laboratories. With the publication of this standard, we will have to markedly change our concept. We have to adopt methods to manage the causes of errors in measurement processes rather than methods to manage only the results of measurements. The new concept of the Quality Management System (QMS) which manages the result of measurements is summarized. With the publication of ISO 15189, the definition of the quality assurance of examination results became clearer and stricter. This report describes the contents of ISO 15189 and the method of enforcing it.

Corp. Author

http://www.ncbi.nlm.nih.gov/pubmed/26591431?dopt=Abstract

Alternate JournalRinsho Byori
PubMed ID26591431