BAS EN ISO 15189:2013
Medical laboratories - Requirements for quality and competence
General Information
Status: Withdrawn
No. of pages: 53
Language: English
Edition: 2.
Adoption method: Endorsment
Publication date: 21.11.2013
Technical committee:
Directive:
765/2008, REGULATION (EC) No 765/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93;
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Abstract
ISO 15189:2012 specifies requirements for quality and competence in medical laboratories.
ISO 15189:2012 can be used by medical laboratories in developing their quality management systems and assessing their own competence. It can also be used for confirming or recognizing the competence of medical laboratories by laboratory customers, regulating authorities and accreditation bodies.
Lifecycle
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Original document and degree of correspondence
- EN ISO 15189:2012, identical
- ISO 15189:2012, identical