Iso 15189 when carrying out work at its permanent facilities andor associated facilities. In addition, the standard provides the detailed definitions of the terms impartiality, complaint, interlaboratory comparison, intralaboratory comparison, proficiency testing. Total 170 files quick download in editable form by e delivery chapter1. Zipordner einzureichende unterlagen medizinische laboratorien 15189. Therefore, in order to be comparable to medical laboratories worldwide, mexican laboratories must be accredited by iso 15189. Laboratory customers, regulatory authorities, organizations and schemes using peerassessment. Seit august 2004 sind wir erfolgreich nach din en iso 15189 akkreditiert. Conformity assessment requirements for the operation of various types of bodies performing inspection isoiec 17020. While this international standard is intended to use throughout recognized disciplines of medical laboratory services. A twopart standard iso 15189 international standard, based upon iso 17025 and iso 9001, provides requirements for competence and quality that are particular to medical laboratories.
A list of organizations represented on this committee can be. It can also be used for confirming or recognizing the competence of medical laboratories by laboratory customers, regulating authorities and accreditation bodies. Publication as an international standard requires approval by at least 75 % of the national bodies casting a vote. At this moment, we have five accredited laboratories and one blood bank. Each member body interested in a subject for which a technical committee has been established has the right. Draft international standards are circulated to the national bodies for voting.
Iso the international organization for standardization is a worldwide federation of national standards bodies iso member bodies. Conformity assessment requirements for the operation of. Iso 15189 documents with manual, procedures, audit checklist. The uk participation in its preparation was entrusted to technical committee ch212, ivds. My personal suggestion is that you would seek to own all of the books listed. The work of preparing international standards is normally carried out through iso technical committees. Medical laboratory accreditation according to iso 15189. Din en iso 15189 200708 medizinische laboratorien besondere anforderungen an. This document is applicable to all organizations performing laboratory activities, regardless of the number of personnel. Download as pptx, pdf, txt or read online from scribd. Check out some of the ministry norbeck social support questionnaire pdf opportunities at norvel hayes ministries.
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