Provides requirements for competence and quality that are particular to medical laboratories. Medical laboratory services include arrangements for requisition, patient preparation, patient identification, collection of samples, transportation, storage, processing and examination of clinical samples, together with subsequent validation, interpretation, reporting and advice, in addition to the considerations of safety and ethics in medical laboratory work. Bodies engaged in the recognition of the competence of medical laboratories will also be able to use this Standard as the basis for their activities. Demonstrated conformity to this Standard does not imply conformity of the quality management system within which the laboratory operates to all the requirements of ISO 9001. This International Standard is not intended to be used for the purposes of certification. Identical to and adopted from ISO 15189:2007.

Supersedes

#N/A Superseded by

#N/A And

15189:2003(NZS/ISO) And

15189:2003(NZS/ISO)A1

ISO 15189:2007 - Identical