메뉴 건너뛰기




Volumn 56, Issue 10, 2018, Pages 1637-1643

Harmonization of accreditation to ISO15189

Author keywords

accreditation; ISO15189; quality management system

Indexed keywords

ACCREDITATION; HUMAN; LABORATORY; PRESCRIPTION; PRIORITY JOURNAL; QUALITY CONTROL; REVIEW; RISK MANAGEMENT; STANDARDIZATION; TOTAL QUALITY MANAGEMENT; HOSPITAL LABORATORY; ORGANIZATION AND MANAGEMENT; POINT OF CARE TESTING; PRACTICE GUIDELINE; STANDARDS; TRENDS;

EID: 85040321037     PISSN: 14346621     EISSN: 14374331     Source Type: Journal    
DOI: 10.1515/cclm-2017-0820     Document Type: Review
Times cited : (22)

References (27)
  • 1
    • 82755167810 scopus 로고    scopus 로고
    • Proficiency testing/ external quality assessment: Current challenges and future directions
    • Miller W, Jones G, Horowitz G, Weykamp C. Proficiency testing/ external quality assessment: current challenges and future directions. Clin Chem 2011;57:1670-80.
    • (2011) Clin Chem , vol.57 , pp. 1670-1680
    • Miller, W.1    Jones, G.2    Horowitz, G.3    Weykamp, C.4
  • 3
    • 85053178210 scopus 로고
    • CLIA67. United States Statutes at Large
    • CLIA67: "Public Law 90-174". United States Statutes at Large, Volume 81. 1967.
    • (1967) Public Law 90-174 , vol.81
  • 4
    • 85053216660 scopus 로고
    • CLIA88 United States Statutes at Large
    • CLIA88: "Public Law 100-578" United States Statutes at Large, Volume 102. 1988.
    • (1988) Public Law 100-578 , vol.102
  • 5
    • 85053219282 scopus 로고    scopus 로고
    • NATA: 50 years experience with accreditation
    • Davies P. NATA: 50 years experience with accreditation. Accred Qual Assur 1996;1:240-6.
    • (1996) Accred Qual Assur , vol.1 , pp. 240-246
    • Davies, P.1
  • 7
    • 85053175540 scopus 로고    scopus 로고
    • Accessed: Jul 2017
    • Cofrac: guide for good laboratory practice. Available at: https:// www. cofrac. fr/fr/documentation/index. php?fol-id=34. Accessed: Jul 2017.
    • Cofrac: Guide for Good Laboratory Practice
  • 10
    • 0033658248 scopus 로고    scopus 로고
    • Usefulness of EC4 essential criteria for quality systems of medical laboratories as guideline to the ISO 15189 and ISO 17025 documents
    • Jansen R, Kenny R, Blaton V, Burnett D, Huisman W, Plebani M, et al. Usefulness of EC4 essential criteria for quality systems of medical laboratories as guideline to the ISO 15189 and ISO 17025 documents. Clin Chem Lab Med 2000;38:1057-64.
    • (2000) Clin Chem Lab Med , vol.38 , pp. 1057-1064
    • Jansen, R.1    Kenny, R.2    Blaton, V.3    Burnett, D.4    Huisman, W.5    Plebani, M.6
  • 13
    • 33744822185 scopus 로고    scopus 로고
    • ISO 15189:2003-Quality management, evaluation and continual improvement
    • Burnett D. ISO 15189:2003-Quality management, evaluation and continual improvement. Clin Chem Lab Med 2006;44:733-9.
    • (2006) Clin Chem Lab Med , vol.44 , pp. 733-739
    • Burnett, D.1
  • 18
    • 84867821406 scopus 로고    scopus 로고
    • European medical laboratory accreditation. Present situation and steps to harmonisation
    • Huisman W. European medical laboratory accreditation. Present situation and steps to harmonisation. Clin Chem Lab Med 2012;50:1147-52.
    • (2012) Clin Chem Lab Med , vol.50 , pp. 1147-1152
    • Huisman, W.1
  • 19
    • 84961778038 scopus 로고    scopus 로고
    • On behalf of the Working Group Accreditation and ISO/CEN standards (WG-A/ISO) of the EFLM, Accreditation process in European countries-an EFLM survey
    • Boursier G, Vukasovic I, Brguljan P, Lohmander M, Ghita I, Bernabeu A, et al. On behalf of the Working Group Accreditation and ISO/CEN standards (WG-A/ISO) of the EFLM, Accreditation process in European countries-an EFLM survey. Clin Chem Lab Med 2016;54:545-51.
    • (2016) Clin Chem Lab Med , vol.54 , pp. 545-551
    • Boursier, G.1    Vukasovic, I.2    Brguljan, P.3    Lohmander, M.4    Ghita, I.5    Bernabeu, A.6
  • 21
    • 84989941155 scopus 로고    scopus 로고
    • Standardization and quality management in next-generation sequencing
    • Endrullat C, Glökler J, Franke P, Frohme M. Standardization and quality management in next-generation sequencing. Appl Trans Genom 2016;10:2-9.
    • (2016) Appl Trans Genom , vol.10 , pp. 2-9
    • Endrullat, C.1    Glökler, J.2    Franke, P.3    Frohme, M.4
  • 22
    • 85026817034 scopus 로고    scopus 로고
    • Verification of examination procedures in clinical laboratory for imprecision, trueness and diagnostic accuracy according to ISO 15189:2012: A pragmatic approach
    • Antonelli G, Padoan A, Aita A, Sciacovelli L, Plebani M. Verification of examination procedures in clinical laboratory for imprecision, trueness and diagnostic accuracy according to ISO 15189:2012: a pragmatic approach. Clin Chem Lab Med 2017;55:1501-8.
    • (2017) Clin Chem Lab Med , vol.55 , pp. 1501-1508
    • Antonelli, G.1    Padoan, A.2    Aita, A.3    Sciacovelli, L.4    Plebani, M.5
  • 23
    • 85026831545 scopus 로고    scopus 로고
    • An approach for estimating measurement uncertainty in medical laboratories using data from long-term quality control and external quality assessment schemes
    • Padoan A, Antonelli G, Aita A, Sciacovelli L, Plebani M. An approach for estimating measurement uncertainty in medical laboratories using data from long-term quality control and external quality assessment schemes. Clin Chem Lab Med 2017;55:1696-701.
    • (2017) Clin Chem Lab Med , vol.55 , pp. 1696-1701
    • Padoan, A.1    Antonelli, G.2    Aita, A.3    Sciacovelli, L.4    Plebani, M.5
  • 25
    • 85053215817 scopus 로고    scopus 로고
    • Regulation of the European Parliament and of the Council on in vitro diagnostic medical devices and repealing Directive 98/79/ EC and Commission Decision 2010/227/EU. Accessed: 9 Sep 2017
    • Regulation of the European Parliament and of the Council on in vitro diagnostic medical devices and repealing Directive 98/79/ EC and Commission Decision 2010/227/EU, Official Journal of the European Union, L 117, 2017;605:176-332. Available at: http://eur-lex. europa. eu/legal-content/EN/TXT/PDF/?uri=CELEX:32017R0746&from=EN. Accessed: 9 Sep 2017.
    • (2017) Official Journal of the European Union, L 117 , vol.605 , pp. 176-332
  • 26
    • 84934326356 scopus 로고    scopus 로고
    • Accreditation ISO/CEN standards (WG-A/ISO) of the EFLM Flexible scope for ISO 15189 accreditation: A guidance prepared by the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) Working Group Accreditation and ISO/CEN standards (WG-A/ ISO)
    • On behalf of the Working Group
    • Thelen M, Vanstapel F, Kroupis C, Vukasovic I, Boursier G, Barrett E, et al. On behalf of the Working Group. Accreditation ISO/CEN standards (WG-A/ISO) of the EFLM Flexible scope for ISO 15189 accreditation: a guidance prepared by the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) Working Group Accreditation and ISO/CEN standards (WG-A/ ISO). Clin Chem Lab Med 2015;53:1173-80.
    • (2015) Clin Chem Lab Med , vol.53 , pp. 1173-1180
    • Thelen, M.1    Vanstapel, F.2    Kroupis, C.3    Vukasovic, I.4    Boursier, G.5    Barrett, E.6
  • 27
    • 85053185981 scopus 로고    scopus 로고
    • Flexible scope for ISO15189 accreditation requires harmonization of scope specificity
    • Thelen M. Flexible scope for ISO15189 accreditation requires harmonization of scope specificity. J Lab Precis Med 2017;2:84.
    • (2017) J Lab Precis Med , vol.2 , pp. 84
    • Thelen, M.1


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.