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ISO 15189 and the medical laboratory - QCNet - A Bio-Rad ...

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ISO 15189 and the medical laboratory - QCNet - A Bio-Rad ...

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: 401

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GUIDELINES FOR THE USE OF CAP 15189 SEAL OF ACCREDITATION

I. INTRODUCTION In 2008 the College of American Pathologists (CAP) began offering CAP 15189SM—an accreditation to the ISO 15189:2007 Standard as published by the

http://www.cap.org/apps/docs/laboratory_accreditation/15189/15189_logo_guidelines.pdf

Date added: May 25, 2013 - Views: 3

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Procedures for Validation of Diagnostic Methods in Clinical ...

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

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

Date added: December 1, 2013 - Views: 18

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Beyond CLIA Regulation: Quality Management System ...

International Guidelines & Standards Beyond CLIA Regulation: ... CLSI QMS ISO 15189 CLIA QSE Clauses Sections Assessments: Internal & External 4.11 Preventive action

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

Date added: December 29, 2011 - Views: 40

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ISO 15189 - quality and competence 09 - Prof Looi LM 04062009

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

http://www.standardsmalaysia.gov.my/documents/10179/23109/ISO%2015189-quality%20and%20competence%20by%20Prof%20Looi%20LM%2004062009.pdf

Date added: April 17, 2013 - Views: 19

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The Future is Now Global Application of CLSI and ISO:15189 ...

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: 5

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The Future is Now: Global Application of CLSI and ISO:15189 ...

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: 8

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Guidelines for Developing a Quality Management Plan

Guidelines for Developing a Quality Management ... The Quality Management approach included in these guidelines is based on ... with ISO standards (refer to ISO 15189).

http://resources.psmile.org/resources/documents-and-records/quality-management-plans/Doc1.0-14%20and%20Appendices%20Guidelines%20for%20Developing%20a%20Quality%20Management%20Plan.pdf

Date added: September 26, 2012 - Views: 68

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Frequently Asked Questions Related to the A2LA 15189 Program

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: 7

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

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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G601 Guideline for A2LA Medical Laboratory Accreditation

ISO 15189, 42CFR493 and Program Specific Documents.....15 Laboratories with current CLIA Certificate of Accreditation ...

http://www.qualitysyria.sy/uploads/Medical_G601.pdf

Date added: June 27, 2014 - Views: 3

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REQUIREMENTS FOR QUALITY MANAGEMENT IN MEDICAL LABORATORIES

Guidelines for Quality Systems in Medical Laboratories Publications Production Unit ... Section 4.15 of AS 4633 (ISO 15189) covers management review. It deals with:

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

Date added: October 26, 2013 - Views: 16

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Basic Quality Management Systems - Home - 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: 1

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Review and comparison of quality standards, guidelines and ...

Review and comparison of quality standards, guidelines and regulations for laboratories Authors: ... ISO 15189, as an international standard, has to maintain a

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

Date added: May 25, 2013 - Views: 3

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Guidance on the documentation requirements of ISO 9001 :2008

Guidance on the Documentation Requirements of ISO 9001:2008 © ISO 2008 ... Users are also referred to ISO/TR 10013 . Guidelines for quality management systems ...

http://www.iso.org/iso/02_guidance_on_the_documentation_requirements_of_iso_9001_2008..pdf

Date added: September 26, 2012 - Views: 522

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Antenatal and newborn screening laboratory standards mapped ...

Antenatal and newborn screening laboratory standards mapped to ISO 15189 About this publication Project/category Antenatal and newborn screening

http://www.screening.nhs.uk/getdata.php?id=17264

Date added: September 15, 2014 - Views: 1

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Quality managementin flow cytometry–requirementsofGLP, GMP ...

GMP, ISO, andclinicalstudies ... Germany: Guidelines of the medical association (RiLiBÄK): compulsory, ... (ISO 15189 4.6.2, 5.3.2),

http://c.ymcdn.com/sites/www.celltherapysociety.org/resource/resmgr/2014_AnnualMtgPresentations/T4_U.Sack.pdf

Date added: June 16, 2014 - Views: 3

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Pre-Microscopic Examination Specimen Handling Guidelines in ...

Pre-Microscopic Examination Specimen Handling Guidelines in the Surgical Pathology Laboratory ... International Standard ISO 15189:2007

http://www.nsh.org/sites/default/files/Pre%20Microscopic%20Examination%20Specimen%20Handling%20Guidelines%20in%20Surgical%20Pathology%20Laboratory.pdf

Date added: July 12, 2013 - Views: 12

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A Practical Guide to Internal Quality Control (IQC) for ...

General guidelines for planning and design of IQC procedures have been provided by ... 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: 82

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Measurement Quality in practice according to recommendations ...

Measurement Quality in practice according to recommendations in ISO/IEC 17025 & ISO 15189 ... important guidelines.

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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Attaining ISO 15189 accreditation through SLMTA: A journey by ...

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: 1

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Quality Management for the Medical Laboratory

Management Professions Guidelines Committee Standards Development Bodies Accreditation Bodies External Quality ... ISO 15189 requirements Management Requirements 1.

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

Date added: April 30, 2012 - Views: 93

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Laboratory Quality Standards

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/entity/health_technology/documents/docs/LaboratoryQualityStandardsandtheirImplementation_9C27.pdf

Date added: May 10, 2013 - Views: 3

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Field Experience in Implementing ISO 15189 in Kisumu, Kenya

guidelines, complaint/incidence reporting systems, quality indicator systems, internal QA auditing systems, ... Zeh et al / Implementing ISO 15189 in Kisumu, Kenya

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

Date added: August 26, 2013 - Views: 13

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ISO 15189 accreditation experience at the Microbiology ...

ISO 15189 accreditation experience at the Microbiology Laboratory of a Turkish University Hospital ... guidelines of the ministry of health in the related country.

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

Date added: November 25, 2013 - Views: 5

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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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New Guidelines for Quality Assurance of the German Medical ...

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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Quality Standards in Health Laboratories - WHO | World Health ...

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: 14

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Guidance for Laboratory Quality Manuals - PIHOA: Pacific ...

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

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: 12

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When Your Hospital CFO Asks: How We Show Our Lab’s Gains ...

cap.org v. 1 When Your Hospital CFO Asks: How We Show Our Lab’s Gains from ISO 15189 And QMS Programs Cheryl Wildermuth, Avera McKennan

http://www.labqualityconfab.com/wp-content/uploads/WILDERMUTH-WOOD.tue_.3pm.FINAL_.pdf

Date added: November 22, 2014 - Views: 1

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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: 2

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EVALUATING THE SUCCESS OF IMPLEMENTING ISO 15189:2003 IN A ...

ISO 15189:2003 IN A MEDICAL LABORATORY by ... using the ISO standard development guidelines, but using medical terminology. ISO 15189 and ISO/IEC

http://libserv5.tut.ac.za:7780/pls/eres/wpg_docload.download_file?p_filename=F487337225/Moodliar%20S.pdf

Date added: September 10, 2012 - Views: 18

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Effective Implementation and Internal Audit of ISO 15189:2012 ...

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: 1

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A Quality Management Toolkit for Molecular Genetic Testing

What’s “Special” in MM20? Extends international QMS standards/guidelines (eg, ISO 15189,CLSI document GP26) into molecular genetic testing

http://eo2.commpartners.com/users/APHL/downloads/588-603-13-Presentation.pdf

Date added: December 2, 2013 - Views: 1

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Joint Commission Laboratory Standards and Quality Management ...

ISO 15189: 4.12 Figure 1. A Quality Management System View of Laboratory Accreditation Standards In future revisions of the Joint Commission laboratory accreditation ...

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

Date added: February 26, 2012 - Views: 56

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ISO 15189:2012 Medical laboratories-Requirements for Quality ...

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

http://nakhonsawan.dmsc.moph.go.th/2011/file/ISO%2015189-2012%20training%203.pdf

Date added: December 22, 2014 - Views: 1

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The Impact of ISO 15189 and ISO 9001 Quality Management ...

The Impact of ISO 15189 and ISO 9001 Quality Management Systems on Reducing Errors Bob White ... Clear guidelines and consistent quality verification for all

http://www.isoindezorg.nl/kennisbank/impact-on-reducing-errors.pdf

Date added: July 15, 2012 - Views: 11

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Health Impact Assessment and the Role of Accredited Clinical ...

Health Impact Assessment and the Role of Accredited Clinical Laboratory on ISO 15189:2007 International Standard 589 Andalusian Public Health System (Ministry of Health,

http://www.researchgate.net/profile/Juan_Sainz/publication/233910469_Health_impact_assessment_and_the_role_of_accredited_clinical_laboratory_on_ISO_151892007_international_standard/links/0c96051596b927cc57000000

Date added: September 15, 2014 - Views: 1

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Regional Guidelines for Establishment of Accreditation for.

Guidelines on Establishment of Accreditation of Health Laboratories 11 Conflict of interest ... aim of accreditation to ISO 15189 shall be the final target.

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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GUIDELINES ON TRAINING COURSE FOR LABORATORY AND INSPECTION ...

Guidelines on Training Course for Laboratory and Inspection Body assessors ... opinions based on objective facts, etc. ISO 15189 requirements for interpretation of

http://www.aplac.org/documents/tr/aplac_tr_001_issue_2.pdf

Date added: March 27, 2012 - Views: 27

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Lab Guidelines - Labmedicine

ISO 15189 was first published in 2003, with minor revisions ... Lab Guidelines &Standards Management System Training Toolkit, which is available on the WHO Web site.

http://labmed.ascpjournals.org/content/42/7/440.full.pdf

Date added: October 13, 2013 - Views: 2

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CONVERTION TO ISO 15189:2012 FOR MEDICAL LABORATORIES

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: 1

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Reducing the Risk of Regulatory Findings: A New Paradigm for ...

Reducing the Risk of Regulatory Findings: ... standards and other international standards such as Good Clinical Laboratory Practice Guidelines (GCLP). ISO 15189:2012: ...

http://www.covance.com/content/dam/covance/assetLibrary/articles/elmsarticle73113finalpdf.pdf

Date added: October 23, 2014 - Views: 1

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NEW EDITION OF ISO 15189:2012

Transitional guidelines to ISO 15189:2012 ... Noting the results of the ISO ballot completed for ISO FDIS 15189 on 11 October 2012, the General

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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MEDICAL LABORATORIES HOSPITAL UNIVERSITI SAINS MALAYSIA

MS ISO 15189:2007. b) Quality Policy ... Guidelines on laboratory construction and design (version 1/2004) College of Pathologist Malaysia Prepared by

http://www.kck.usm.my/husm/pharmacy/images/ISO/aras1/laboratory_quality_manual_jul-2010.pdf

Date added: April 10, 2012 - Views: 22

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Quality Management in the Laboratory - Welcome to the UCLA ...

Quality Management in the Laboratory Ann Shadler, MT(ASCP)SBB Clinical Laboratory Manager Department of Pathology & Laboratory Medicine

http://pathology.ucla.edu/workfiles/Education/Transfusion%20Medicine/16-1-Quality-Management-Shadler.pdf

Date added: January 3, 2013 - Views: 21

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Lab Guidelines - Labmedicine

Lab Guidelines & Standards . 26. LAB ... (ISO), the Clinical Laboratory Improvement Amendments, ... • Mapping of the QSEs to ISO standards 15189:2007, 17025:2005 ...

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

Date added: September 25, 2013 - Views: 16

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ISO 15189 Medical Laboratory Accreditation Workshop and ...

n Identify CLSI and ISO guidelines that describe risk management. ... 1:00 pm to 1:45 pm Overview of ISO 15189 Technical Requirements Greg Cooper, CLS, MHA

http://www.qcnet.com/Portals/0/Events/15189workshop.pdf

Date added: March 31, 2012 - Views: 4

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PRESENTATION CATALOGUE 2013 - TÜV Rheinland, TUV Rheinland ...

guidelines); Presentation of the ... Interactions between SR EN ISO 15189 and SR EN ISO 19011, case studies (6 hours) Forms of assessment: Written test: Multiple ...

http://www.tuv.com/media/romania/cursuri/catalogues_academy/catalog_2013_laboratoare_etalonari_medicale_en.pdf

Date added: May 20, 2013 - Views: 3