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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: 399

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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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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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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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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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Guidelines for Laboratory Accreditation according to EN ISO 15189

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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Road to ISO 15189 Accreditation for St. Sugustine Medical ...

ROAD TO ISO 15189 ACCREDITATION FOR ST. AUGUSTINE MEDICAL LABORATORY LTD. MIK-ARL Building, 143 Eastern Main Road, St. Augustine. Trinidad. Website:

http://www.aacc.org/resourcecenters/archivedprograms/expert_access/2009/january/Documents/ExpertAccess0109.pdf

Date added: December 3, 2012 - Views: 21

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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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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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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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Quality managementin flow cytometry–requirementsofGLP, GMP ...

laboratories [EN ISO 15189:2007; RL 90/385/EWG, 93/42 EWG, 98/79/EG and DIN EN ISO/IEC 17025]. ... Germany: Guidelines of the medical association (RiLiBÄK):

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

Date added: June 16, 2014 - Views: 1

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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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REQUIREMENTS FOR QUALITY MANAGEMENT IN MEDICAL LABORATORIES

standards, and initiate and promote guidelines and education programs about ... In relation to management review, AS 4633 (ISO 15189) differs on some points from ISO/

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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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: 1

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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: 505

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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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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: 12

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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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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: 9

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List of Quality System Standards - 9000 Advisers

ISO 19011:2002 - Guidelines on Quality and/or Environmental Management ... ISO 15189 ISO 15189:2003 – Medical laboratories — Particular requirements for quality and

http://www.9000advisers.com/pdf_files/List-of_Quality_Standards.pdf

Date added: November 4, 2014 - Views: 1

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Measurement Quality in practice according to recommendations ...

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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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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National Laboratory Guidelines for Pandemic Influenza

These guidelines will be updated as necessary, ... and NZS/ISO 15189:2003. 4 National Laboratory Guidelines for Pandemic Influenza 3 Clinical Diagnosis

http://www.health.govt.nz/system/files/documents/publications/national-laboratory-guidelines-pandemic-influenza.pdf

Date added: June 2, 2013 - Views: 1

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Quality Management for the Medical Laboratory

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

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

Date added: April 30, 2012 - Views: 91

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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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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/download/216/209

Date added: November 22, 2014 - Views: 1

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Laboratory Quality Standards - World Health Organization

Laboratory Information Systems. 6. Equipment and Supplies. 7. Guidelines. I ... (ISO) 15189 and ISO 17025 have ... International Standards Organization ...

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

Date added: May 10, 2013 - Views: 3

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Basic Quality Management Systems

ai ai aagee e Page iv A Note on ISO standards and CLSI guidelines This book discusses many different standards and guidelines related to Quality Management Systems ...

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

Date added: November 22, 2014 - Views: 1

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

Effective Implementation and Internal Audit of ISO 15189:2012 ... for formulating specific guidelines criteria for medical laboratories. He has contributed

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

Date added: August 17, 2014 - Views: 1

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

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: 81

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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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Point-of-care testing (POCT) — Requirements for quality and ...

Point-of-care testing (POCT) — Requirements for quality and ... ISO 15189:2003, Medical laboratories – Particular requirements for quality and competence

http://www.cicca.net/materiale/ISO22870.pdf

Date added: January 15, 2012 - Views: 410

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Laboratory Quality Management System - WPRO | WHO Western ...

ISO 15189:2007 Quality management ... 25 countries, and on guidelines developed by CLSI for implementing a quality management system in health laboratories

http://www.wpro.who.int/health_technology/documents/docs/LQMStrainingtoolkitintroduction_Kojima_D9D7.pdf

Date added: May 23, 2013 - Views: 36

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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: 1

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

of ISO 15189:2003 (ISO, 2003a) as the standard for medical laboratories, took ... using the ISO standard development guidelines, but using medical terminology.

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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ISO 15189 Medical Laboratory Accreditation Workshop and ...

n Identify CLSI and ISO guidelines that ... of ISO 15189 Accreditation Chinu ... 2009 where he serves as Manager of Advanced Statistical Research in Bio-Rad’s ...

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

Date added: March 31, 2012 - Views: 4

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INTERNATIONAL ISO STANDARD 19011 - CNIS

INTERNATIONAL STANDARD ISO 19011:2011(E) Guidelines for auditing management systems 1 Scope This International Standard provides guidance on auditing management ...

http://www.cnis.gov.cn/wzgg/201202/P020120229378899282521.pdf

Date added: September 27, 2012 - Views: 544

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LABORATORY QUALITY MANUAL MEDICAL LABORATORIES ...

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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SKIM AKREDITASI MAKMAL MALAYSIA (SAMM) LABORATORY ...

ILAC-G14: 2000 “Guidelines for the use of accreditation body logos and for claims of ... 17025 or for medical testing laboratory MS ISO 15189 is printed under

http://standardsmalaysia.gov.my/documents/10179/26543/SP3.pdf

Date added: September 27, 2014 - Views: 1

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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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Methodology and Quality Assurance Considerations in ...

ISO 15189) (1). These guidelines describe numerous quality ... guidelines: molecular genetic testing for ultra-rare disorders. Genet Med 2005;7:571-83. 5.

http://www.aacc.org/members/nacb/LMPG/OnlineGuide/PublishedGuidelines/LAACP/Documents/PGx_chapter3.pdf

Date added: May 27, 2012 - Views: 4

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GUIDELINES ON TRAINING COURSE FOR LABORATORY AND INSPECTION ...

opinions based on objective facts, etc. ISO 15189 requirements for interpretation of ... refer to ISO 19 011 Guidelines on Quality and

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

Date added: March 27, 2012 - Views: 27

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PRESENTATION CATALOGUE 2013 - TÜV 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

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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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Laboratory Quality Management System Training Toolkit Current ...

Chapter 9: Biological safety cabinets. In: The laboratory biosafety guidelines, 3rd ed. Ottawa, Public Health Agency of Canada, ... ISO 15189:2007 (5.6.4).

http://www.who.int/entity/ihr/training/laboratory_quality/lab_toolkit4_references.pdf

Date added: January 30, 2012 - Views: 45

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NEW EDITION OF ISO/IEC 15189:2012

Transitional guidelines to ISO 15189:2012 On 1st November 2012 the standard ISO 15189:2012 Medical Laboratories- Requirements for Quality

http://kenas.go.ke/wp-content/uploads/2013/12/tRANSITION-TO-NEW-ISO-15189.pdf

Date added: November 22, 2014 - Views: 1