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ISO 15189 and the medical laboratory - QCNet

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ISO 15189 and the medical laboratory - QCNet

Topics for discussion… • Origins and development of ISO 15189 • Role in accreditation and regulation • Practical application in the laboratory

http://www.qcnet.com/Portals/49/PDFs/2011/DBu_%20ISO%2015189%20and%20the%20medical%20laboratory.pdf

Date added: April 25, 2012 - Views: 419

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R305 - General Requirements - Accreditation of ISO...

L:\Requirements\R305 – General Requirements: Accredita tion of ISO 15189 Medical Testing Laboratories (5/3/07) Page 1 of 17 R305 - General Requirements:

http://a2la.org/requirements/15189_General_Requirements.pdf

Date added: February 5, 2012 - Views: 540

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Everything you want to know about ISO 15189:2012...

Everything you want to know about ISO 15189:2012 Medical Laboratories – Requirements for Quality and Competence Michael A Noble MD FRCPC CMPT and POLQM

http://www.polqm.ca/pdf/2013Saudie/Noble%20-%2015189-Past%20Present%20Future.pdf

Date added: December 9, 2013 - Views: 52

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REQUIREMENTS FOR QUALITY MANAGEMENT IN MEDICAL...

standards, and initiate and promote guidelines and education programs about ... (Management requirements) of AS 4633 (ISO 15189). Requirements and guidelines for

http://www.health.gov.au/internet/main/publishing.nsf/Content/763BEAEFC14C0E54CA257BF0001DC710/$File/dhaquality.pdf

Date added: October 26, 2013 - Views: 23

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ISO 15189 Application Document-Medical Testing...

Medical Testing ISO 15189 Field Application Document November 2013 Page 6 of 31 Minimum retention times (including raw data) must be in accordance with those

http://www.nata.com.au/nata/phocadownload/publications/Accreditation_criteria/ISO15189-Medical/MEDFAD.pdf

Date added: June 19, 2014 - Views: 16

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Beyond CLIA Regulation: Quality Management System...

International Guidelines & Standards Beyond CLIA Regulation: ... CLSI QMS ISO 15189 CLIA QSE Clauses Sections Process control 5.4 Pre-examination procedures

http://wwwn.cdc.gov/cliac/pdf/Addenda/cliac0907/AddendumP.pdf

Date added: December 29, 2011 - Views: 50

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Guidelines for Laboratory Accreditation according...

Hellenic Accreditation System ESYD G-CLINLAB 01/02/30-01-2014 1/16 Guidelines for Laboratory Accreditation according to EN ISO 15189

http://www.esyd.gr/pweb/s/20/files/EN/kanonismoi/G-CLINLAB_30012014_EN.pdf

Date added: October 23, 2014 - Views: 1

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Procedures for Validation of Diagnostic Methods in...

ISO 15189 standard emphasizes so in the quality of contributions to patient care ... guidelines for method validation procedures in clinical laboratories through the ...

http://www.intechopen.com/download/pdf/22135

Date added: December 1, 2013 - Views: 18

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Regional Guidelines for Establishment of...

Guidelines for Establishment of Accreditation of Health Laboratories iii Contents ... ISO 15189 for medical laboratories in order to eventually achieve the

http://www.who.int/ihr/training/laboratory_quality/11_cd_rom_publications_sea_hlm_394.pdf

Date added: February 21, 2013 - Views: 3

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The Future is Now Global Application of CLSI and ...

The Future is Now Global Application of CLSI and ISO:15189 Quality Management Systems Glen Fine, MS, MBA Executive Vice President, CLSI Key Discussion Points

http://www.labqualityconfab.com/wp-content/uploads/Fine.pdf

Date added: September 30, 2013 - Views: 6

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TEMPLATE FOR GAP ANALYSIS AGAINST ISO 15189:2012

Page 1 of 47 Template for Gap Analysis Against ISO 15189:2012 [QF-PAT-ISO 15189:2012] Version 1 Approved by R Peatey on 31/01/2014 Review Period: Biennial

http://www.transfusionguidelines.org.uk/document-library/documents/appendix-1-pdf-265kg/download-file/Appendix%201.pdf

Date added: October 21, 2014 - Views: 10

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Quality Standards in Health Laboratories

ISO Guidelines 15189 Medical laboratories – Particular requirements for quality and competence ... development and only 5% used the ISO 15189 standards.

http://www.who.int/ihr/training/laboratory_quality/11_cd_rom_quality_standards_in_health_laboratories_thailand.pdf

Date added: February 9, 2013 - Views: 20

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ISO 15189 - quality and competence 09 - Home -...

ISO 15189 An international standard for the development of quality systems and accreditation for medical / clinical laboratories Takes into account contribution of ...

http://www.jsm.gov.my/documents/10180/252844/ISO+15189-quality+and+competence+by+Prof+Looi+LM+04062009.pdf/2fd835de-51e8-4d4d-8402-4e4a93c883e0

Date added: February 27, 2015 - Views: 2

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Laboratory Quality Standards - World Health...

ISO 19011 Guidelines for quality and/or environmental management system auditing ... to retain the essential components of the ISO 15189 laboratory standards.

http://www.wpro.who.int/health_technology/documents/docs/LaboratoryQualityStandardsandtheirImplementation_9C27.pdf

Date added: July 10, 2013 - Views: 25

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CLSI QMS ISO 15189 CLIA - Centers for Disease...

Comparison: CLSI QMS Model to ISO 15189 and CLIA Regulations CLSI QMS ISO 15189 CLIA QSE Clauses Sections Organization 4.1 Organization and Management

http://wwwn.cdc.gov/cliac/pdf/Addenda/cliac0907/AddendumP1.pdf

Date added: February 26, 2012 - Views: 21

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AS 4633 ( ISO 15189) APPLICATION DOCUMENT - QCNet

AS 4633 (ISO 15189) APPLICA TION DOCU MENT: 2005 V ersion 1 SECTION 7: REFERENCES NPAAC PUBLICATIONS Guidelines for Approved Pathology Collection Centres

http://www.qcnet.com/Portals/40/PDFs/NATA_Supplemental%20Requirements%2015189.pdf

Date added: February 9, 2012 - Views: 41

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Field Experience in Implementing ISO 15189 in...

ing ISO 15189 as the appropriate international accreditation standard for our laboratory. ... guidelines, complaint/incidence reporting systems, quality

http://ajcp.ascpjournals.org/content/134/3/410.full.pdf

Date added: August 26, 2013 - Views: 20

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Frequently Asked Questions Related to the A2LA ...

involvement, has been instrumental in the development of ISO standards, including ISO 15189. ... accreditation and assessment guidelines for medical testing ...

http://www.a2la.org/faq/medical_15189.pdf

Date added: January 28, 2014 - Views: 16

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The Future is Now: Global Application of CLSI and ...

The Future is Now: Global Application of CLSI and ISO:15189 Quality Management Systems Executive War College May 5, 2009 Glen Fine, MS, MBA Executive Vice President, CLSI

http://www.executivewarcollege.com/wp-content/uploads/2012/04/Fine.pdf

Date added: June 26, 2013 - Views: 10

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Basic Quality Management Systems - Westgard

implementation of the CAP-ISO 15189 guidelines. The Wallace H. Coulter Foundation stimulated the development of

http://www.westgard.com/images/stories/BQMS-Preview.pdf

Date added: November 22, 2014 - Views: 19

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ISO 15189 accreditation experience at the...

guidelines of the ministry of health in the related country. Clinical microbiology is mostly based on interpretation ... ISO/IEC 15189:2007 standard (ISO 15189 Standards,

http://www.academicjournals.org/article/article1380213760_Gurol%20et%20al.pdf

Date added: November 25, 2013 - Views: 11

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Standards

Dr Fiona Thomson-Carter, General Manager of Environmental Health says accreditation is an ... NZS/ISO 15189:2007, Medical laboratories – Particular

http://www.standards.co.nz/assets/News/Case-studies/CaseStudyESRweb.pdf

Date added: May 4, 2014 - Views: 1

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Procedures for Validation of Diagnostic Methods in...

11 Procedures for Validation of Diagnostic Methods in Clinical Laboratory Accredited by ISO 15189 Silvia Izquierdo Álvarez and Francisco A. Bernabeu Andreu

http://cdn.intechopen.com/pdfs/22135/InTech-Procedures_for_validation_of_diagnostic_methods_in_clinical_laboratory_accredited_by_iso_15189.pdf

Date added: October 25, 2012 - Views: 67

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Standards for the Medical Laboratory - The United...

competent person(s) with responsibility for, and authority over, a laboratory [ISO 15189:2007] ... with regard to current regulations and guidelines, the

http://www.ukas.com/Library/Services/CPA/Publications-CPA-accreditation/Standards%20for%20the%20Medical%20Laboratory.pdf

Date added: April 3, 2014 - Views: 4

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Abridged Version ISO 15189 : 2012) Technical...

Guidelines for the Use of Accreditation Symbols and for Claims of Accreditation Status by Accredited Laboratories ... Comparison of ISO 15189:2007 to ISO 15189:2012

http://www.itc.gov.hk/en/quality/hkas/doc/hoklas/HOKLAS015-Abridged.pdf

Date added: April 30, 2012 - Views: 140

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Review and comparison of quality standards, ...

guidelines and regulations ... ISO 15189, as an international standard, has to maintain a certain level of generality to make it applicable in multiple

http://www.ajlmonline.org/index.php/ajlm/article/viewFile/3/5

Date added: May 25, 2013 - Views: 3

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ISO 15189:2012 Summary of ISO 15189 additional...

ISO 15189:2012 Clause Summary of ISO 15189 additional requirements 4.1.1.3.d Ethical conduct Procedures to deal with disposal of human samples, remains etc. according ...

http://www.ukas.com/Library/Services/CPA/Summary%20of%20Idifferences%20betwen%20ISO%2015189%20%26%20CPA.pdf

Date added: November 20, 2013 - Views: 8

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ISO 15189 The Next Step in Laboratory Quality -...

ISO 15189 – The Next Step in Laboratory Quality Presented by: Chloe CMScott, MLS(ASCP) , CQA(ASQ) BioQ Solutions, LLC [email protected]

http://asclsregionx.com/Pres/Pres_08.pdf

Date added: April 7, 2013 - Views: 137

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Lab Guidelines

Lab Guidelines & Standards . 26. LAB. ... • Mapping of the QSEs to ISO standards 15189:2007, 17025:2005, and 9001:2008 • Examples of a validation protocol ...

http://labmed.ascpjournals.org/content/43/1/26.full.pdf

Date added: September 25, 2013 - Views: 18

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NEW EDITION OF ISO 15189:2012 - The Kenya...

Kenya Accreditation Service (KENAS) currently uses the International Standards Organization ISO 15189:2007 as generic accreditation criteria for all medical laboratories.

http://kenas.go.ke/wp-content/uploads/2013/12/tRANSITION-TO-NEW-ISO-151893.pdf

Date added: February 7, 2014 - Views: 72

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XML Schema For Writing ISO 15189: 2007 - Compliant...

XML Schema For Writing ISO 15189: ... prepared by the laboratory as per guidelines ... ISO/IS 15189:2007 and NABL-112 was referred.

http://www.ejmanager.com/mnstemps/18/18-1359150607.pdf

Date added: December 12, 2013 - Views: 6

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International Accreditation New Zealand Medical...

International Accreditation New Zealand Medical Testing Guidelines and Standards Two of the fundamental purposes of laboratory accreditation are to foster continuous ...

http://www.ianz.govt.nz/wp-content/uploads/2014/09/International-Accreditation-New-Zealand.pdf

Date added: October 22, 2014 - Views: 3

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Measurement Quality in practice according to...

important guidelines. Target group. Analytical chemists, laboratory responsible, ... and the demand according to the ISO standards 17025/15189. COURSES . Program

http://www.sp.se/en/training/Documents/Program%20Measurement%20Quality%20SP%20course%20140611%20(5).pdf

Date added: January 11, 2014 - Views: 2

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ESYD ACCREDITATION CRITERIA AND GUIDELINES -...

ESYD ACCREDITATION CRITERIA AND GUIDELINES . Hellenic Accreditation System ... 2 Medical Laboratories ΕLΟΤ ΕΝ ISO 15189:2007 ΕLΟΤ ΕΝ ISO 15189:2012 ESYD RA

http://li61-106.members.linode.com/pweb/s/20/files/EN/kanonismoi/CAC_24_2_2015.pdf

Date added: July 18, 2015 - Views: 1

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Uncertainty of Measurement in Quantitative Medical...

Preface These guidelines have been produced in response to the Australian requirement for medical testing laboratories to be accredited under ISO 15189 as from 1st ...

http://www.aacb.asn.au/documents/item/1211

Date added: March 2, 2014 - Views: 1

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Effective Implementation and Internal Audit of ISO...

Mar 2014 Brochure -ISO 15189:2012 (Jun 25 - 28, ... for formulating specific guidelines criteria for ... ISO/IEC 17025, ISO 15189 & ISO 9001 Standards,

http://www.ficciqualityforum.com/htm/jun28/Brochure.pdf

Date added: August 17, 2014 - Views: 10

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CONVERTION TO ISO 15189:2012 FOR MEDICAL...

CONVERTION TO ISO 15189:2012 FOR MEDICAL LABORATORIES D uring the General Assembly held on 11 October 2012, the ILAC Resolution GA 16.21 was adopted, and it was

http://www.sanas.co.za/reports/report03-2014.pdf

Date added: April 23, 2014 - Views: 12

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Laboratory accreditation-procedural guidelines

LABORATORY ACCREDITATION - PROCEDURAL GUIDELINES A.S .Kanagasabapathy and Pragna Rao Kamineni ... followed by NABL is ISO 15189, specific for medical

http://link.springer.com/content/pdf/10.1007%2FBF02867425.pdf

Date added: July 1, 2015 - Views: 1

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ISO 15189:2012 Medical laboratories-Requirements...

ISO 15189:2012 Medical laboratories-Requirements for Quality and competence ... international consensus stds or guidelines - The identity of persons performing recorded

http://www.dmsc.moph.go.th/userfiles/files/15189ver2012.pdf

Date added: September 16, 2014 - Views: 3

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Gap Analysis of ISO 15189 - The Kenya...

Gap Analysis of ISO 15189:2012 and ISO 15189:2007 in the field of Medical Laboratories ... Gap analysis of general information sections/ transition guidelines

http://kenas.go.ke/wp-content/uploads/2013/12/GapAnalysisofISO15189.pdf

Date added: May 26, 2015 - Views: 1

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Joint Commission Laboratory Standards and Quality...

standards, CLSI QSEs and ISO 15189:2007 in an ISO 9001 style Laboratory user Requirements Organization, Management, and QMS Resource management Level of satisfaction

http://www.jointcommission.org/assets/1/18/iso_monograph_branded_Sept_2011.pdf

Date added: February 26, 2012 - Views: 61

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Medical laboratories — Requirements for safety

As with all such safety guidelines, ... ISO 15189:2003, Medical laboratories — Particular requirements for quality and competence 3 Terms and definitions

http://scienz.org/file_foto_utente/conference/ISO%2015190_2003%20Laboratori%20Medici.pdf

Date added: October 6, 2012 - Views: 154

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AS ISO 15189-2009 Medical laboratories—Particular...

AS ISO 15189—2009 ISO 15189:2007 Australian Standard® Medical laboratories—Particular requirements for quality and competence AS ISO 15189—2009

http://infostore.saiglobal.com/store/PreviewDoc.aspx?saleItemID=1637359

Date added: February 26, 2012 - Views: 39

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A Practical Guide to Internal Quality Control...

As defined in the Harmonized Guidelines for Internal Quality Control in Analytical ... ISO 15189:2007 Medical laboratories – Particular requirements for quality and

http://www.hkaml.org/documents/Final_Printing_Version_Sept_2009_A_Practical_Guide_To_IQC_HKAML.pdf

Date added: October 7, 2012 - Views: 92

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New Guidelines for Quality Assurance of the German...

INSTAND ICBS Outline 1 Global dimension of infectious diseases 2 Quality management: -(certification versus) -accreditation EN ISO 15189 versus - New Guidelines for ...

http://www.instandev.de/uploads/tx_nfextsymposdownloads/04-Zeichhardt.pdf

Date added: July 9, 2012 - Views: 1

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A Companion to PG- ISO-LM CPA Standards April 2013

David Burnett ©2013 1 A companion to ‘A Practical Guide to ISO 15189 in Laboratory Medicine’ for those laboratories implementing ISO 15189:2012 or making the

http://acb61.acb.org.uk/docs/default-source/books/a-companion-to-pg-iso-lm-_cpa-standards-april-2013.pdf?sfvrsn=2

Date added: March 20, 2014 - Views: 7

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Guidance for Laboratory Quality Manuals

Table 1: ISO 15189:2003 Style Quality Manual Table of Contents 9 Table 2: ... Quality management systems —Guidelines for performance improvements

http://www.pihoa.org/fullsite/newsroom/wp-content/uploads/downloads/2012/04/Guidance-for-Lab-Quality-Manuals-v.3.pdf

Date added: June 1, 2013 - Views: 15

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Quality Management for the Medical Laboratory

Quality Management for the Medical ... • ISO 15189:2003 Essentials – CSA ... • History’s evolution to Standards and Guidelines • Quality Partnerships

http://www.bcsls.net/pages/documents/GettingAccreditationReadyDrNobleTHweb.pdf

Date added: April 30, 2012 - Views: 103

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Attaining ISO 15189 accreditation through SLMTA: A...

Attaining ISO 15189 accreditation through SLMTA: A ... policy and guidelines on HIV laboratory-related issues and coordinating activities and partners.

http://www.ajlmonline.org/index.php/ajlm/article/viewFile/216/209

Date added: December 13, 2014 - Views: 3