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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: 416

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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: 535

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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: 43

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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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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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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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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: 130

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Guidance for Laboratory Quality Manuals

Guidance for Laboratory Quality Manuals ... ISO 15189:2003 Style Quality Manual Table of Contents 9 ... Quality management systems —Guidelines for performance ...

http://www.pihoa.org/fullsite/newsroom/wpdownloads/Guidance-for-Lab-Quality-Manuals-v.3.pdf

Date added: July 30, 2013 - Views: 12

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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: 14

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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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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: 8

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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: 15

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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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Joint Commission Laboratory Standards and Quality...

4 Laboratory accreditation standards showing Joint Commission standards, CLSI QSEs and ISO 15189:2007 in an ISO 9001 style Laboratory user Requirements

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

Date added: February 26, 2012 - Views: 61

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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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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: 8

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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: 20

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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: 59

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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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ANNB Screening Laboratory Standards Mapped To ISO ...

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: 2

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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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Pre-Microscopic Examination Specimen Handling ...

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: 15

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Guidelines for Developing a Quality Management...

The Quality Management approach included in these guidelines is based on the 12 ... 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: 75

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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 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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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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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: 40

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Quality managementin flow...

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: 3

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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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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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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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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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Effective Implementation and Internal Audit of ISO...

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: 10

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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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List of Quality System Standards

List of Quality System Standards ISO 9000, ISO 9001 and ISO 9004 The ISO 9000 family of standards has been developed to assist organizations of all types

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

Date added: October 19, 2011 - Views: 341

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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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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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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

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Laboratory Quality Standards - World Health...

Laboratory Quality Standards and their Implementation ix Scope and objectives The objective of this document on Laboratory Quality Standards is for it to

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

Date added: July 10, 2013 - Views: 25

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VALIDATION AND VERIFICATION OF ANALYTICAL METHODS...

ISO 15189). Results of validation and verification processes form: ... Harmonised guidelines for the use of recovery information in analytical measurement.

http://www.cskb.cz/res/file/dokumenty/validation-and-verification-of-analytical-methods.pdf

Date added: April 10, 2012 - Views: 25

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Health Impact Assessment and the Role of...

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.pdf

Date added: April 7, 2015 - Views: 1

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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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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: 2

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Content Sheet 15-1: Continual Improvement Concept

improvement ISO 15189 [4.12] describes a very similar set of activities for achieving continual improvement in the laboratory. ... guidelines In selecting quality ...

http://www.who.int/ihr/training/laboratory_quality/15_b_content_process_improve.pdf

Date added: March 15, 2012 - Views: 14

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GUIDELINES ON TRAINING COURSE FOR LABORATORY AND...

Guidelines on Training Course for Laboratory and Inspection Body assessors ... etc. ISO 15189 requirements for ... refer to ISO 19 011 Guidelines on Quality ...

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

Date added: March 27, 2012 - Views: 27

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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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ACCREDITATION MANUAL FOR LABORATORYRELATED...

1.1. ANAB follows ISO 19011, Guidelines for auditing management systems, ... • MA 2016, ISO 15189 Accreditation Requirements for Medical Laboratories

http://www.anab.org/media/31586/ma-2001-lab-accreditation-requirements.pdf

Date added: March 20, 2015 - Views: 2

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L NATIONAL GUIDELINES FOR SETTING UP A MEDICAL...

NATIONAL GUIDELINES FOR SETTING UP A MEDICAL ... The requirements of ISO 15189 are quite ... medical Laboratory Scientist and must be registered member of

http://www.mlscn.gov.ng/files/mlscn_docs/National%20Guidelines%20for%20Setting%20up%20Medical%20Lab%20in%20Nigeria.pdf

Date added: August 6, 2013 - Views: 2

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Topic guide 4.4: Quality assurance in the...

4.4: Quality assurance in the laboratory ISO 9001:2008 ... Accreditation (CPA) guidelines which are based on ISO 15189. Documentation such as risk

http://www.contentextra.com/lifesciences/files/topicguides/LS_TG4_4.pdf

Date added: January 1, 2014 - Views: 3