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ISO 15189 and the medical laboratory - QCNet

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ISO 15189 and the medical laboratory - QCNet

ISO 15189 ISO/TC 212 –Clinical laboratory testing and in vitro diagnostic systems (1995) WG1 Quality and competence in the ... • Obviate the need for guidelines

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

Date added: April 25, 2012 - Views: 456

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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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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: 102

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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: 561

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Procedures for Validation of Diagnostic Methods in...

Procedures for Validation of Diagnostic Methods in Clinical La boratory Accredited by ISO 15189 211 Precise, but inaccurate IQC OK EQA fails Precise, andaccurate

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

Date added: December 1, 2013 - Views: 30

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Beyond CLIA Regulation: Quality Management System...

Quality Management System International Guidelines & Standards Beyond CLIA Regulation: ... ISO 15189:2003, continued ISO 15189:2003, continued 1. Personnel 2.

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

Date added: December 29, 2011 - Views: 66

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REQUIREMENTS FOR QUALITY MANAGEMENT IN MEDICAL...

Requirements for Quality Management in Medical Laboratories G1 Organisation and management G . Relevant section of AS 4633 (ISO 5 89) Section 4.1 of AS 4633 (ISO ...

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

Date added: October 26, 2013 - Views: 50

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Read More on ISO 17025 Awareness - UNIDO

ISO 17025 and, in those areas where ... and its guidelines on implementing systems and procedures to meet these ... ISO 15189 (medical laboratory accreditation),

http://www.unido.org/fileadmin/user_media/Publications/Pub_free/Complying_with_ISO_17025_A_practical_guidebook.pdf

Date added: February 13, 2012 - Views: 248

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

CLSI QMS ISO 15189 CLIA QSE Clauses Sections Organization 4.1 Organization and Management 4.2 Quality management system 4.15 Management review

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

Date added: February 26, 2012 - Views: 23

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Frequently Asked Questions Related to the A2LA ISO...

L:\Marketing Materials\Frequently Asked Questions Related to the A2LA ISO 15189 Program (9/29/14) Page 3 of 12 ISO and the International ...

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

Date added: September 17, 2015 - Views: 2

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ISO 15189 Application Document - NATA

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: 37

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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: 20

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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: 172

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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: 19

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INTERNATIONAL ISO/IEC STANDARD 17025 - saba.org.ir

ISO (the International Organization for Standardization) and IEC ... Software engineering — Guidelines for the application of ISO 9001:2000 to computer

http://www.saba.org.ir/saba_content/media/image/2011/04/1821_orig.pdf

Date added: April 11, 2012 - Views: 611

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ISO 15189 - quality and competence 09 - JSM Portal

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: 16

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Regional Guidelines for Establishment of...

ISO 15189 for medical laboratories in order to eventually achieve the ... Guidelines on Establishment of Accreditation of Health Laboratories 41

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 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: 18

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Measurement Quality in practice according to...

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

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

Date added: May 3, 2016 - Views: 1

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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: 62

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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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Attaining ISO 15189 accreditation through SLMTA: A...

Attaining ISO 15189 accreditation through SLMTA: A ... with the goal of attaining ISO 15189 ... Post-exposure guidelines in place Post-exposure guidelines developed

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

Date added: December 13, 2014 - Views: 11

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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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Basic Quality Management Systems - Westgard

Basic Quality Management Systems Essentials for Quality Management in the Medical Laboratory James O. Westgard, PhD ... implementation of the CAP-ISO 15189 guidelines.

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

Date added: November 22, 2014 - Views: 34

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NEW EDITION OF ISO 15189:2012 - KENAS

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: 76

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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: 195

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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: 25

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Gap Analysis of ISO 15189 - KENAS

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: 18

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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: 38

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Laboratory Quality Management: A Roadmap - ISO ...

Laboratory Quality Management: A Roadmap Lucia M. Berte, MA, MT ... laboratory standard ISO 15189, ... Several guidelines are available to assist laboratories in such ...

http://iso15189medlabmanuals.com/doc/LQM_Roadmap%20Lab%20Quality%20Management%20Roadmap.pdf

Date added: February 9, 2012 - Views: 35

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Investigating the suitability of ISO 15189:2007...

INVESTIGATING THE SUITABILITY OF ISO 15189:2007 FOR MEDICAL RESEARCH . by . Sarah Shoshana Cohen . Master’s dissertation Submitted in fulfilment

https://ujdigispace.uj.ac.za/bitstream/handle/10210/8434/cohen.pdf?sequence=1

Date added: March 31, 2015 - Views: 1

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Laboratory Quality Management System Handbook -...

Laboratory quality management system: handbook. ... more than 25 countries, and on guidelines for implementation of ISO 15189 in diagnostic laboratories, ...

http://whqlibdoc.who.int/publications/2011/9789241548274_eng.pdf

Date added: April 19, 2012 - Views: 60

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Iso 15189 General Checklist - Pdfsdocuments.com

Iso 15189 General Checklist.pdf ... Pre-Microscopic Examination Specimen Handling Guidelines in ... ... ISO 15189 accreditation experience at the Microbiology ...

http://www.pdfsdocuments.com/iso-15189-general-checklist.pdf

Date added: December 13, 2014 - Views: 7

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A Practical Guide to Internal Quality Control...

A Practical Guide to Internal Quality Control (IQC) for Quantitative Tests in Medical Laboratories (Proposed Guidelines) Edited by Richard Pang, PhD, FACB

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

Date added: October 7, 2012 - Views: 121

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Guidance on the documentation requirements of ISO...

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

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

Date added: September 26, 2012 - Views: 714

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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: 12

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Analytical Method Validation and Verification ...

Analytical Method Validation and Verification Guidelines: A Primer ... ISO 15189 and ISO 17025 are not prescriptive in how validation/verification should

https://simplyinfocation.files.wordpress.com/2015/08/review-of-guidelines-for-analytical-method-validation.pdf

Date added: January 16, 2016 - Views: 1

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Joint Commission Laboratory Standards and Quality...

Joint Commission Laboratory Standards and Quality Management Systems ... ISO 15189 There is now a burgeoning interest in laboratory accreditation concerning the

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

Date added: February 26, 2012 - Views: 61

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Laboratory Quality Standards - WPRO

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?ua=1

Date added: December 11, 2015 - Views: 1

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Guidance for Laboratory Quality Manuals - PIHOA

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

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

Date added: April 13, 2016 - Views: 1

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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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Risk Management: Why It Is Part of ISO 15189 and...

Risk Management: Why It Is Part of ISO 15189 and How It Relates to CLIA's IQCP Megan Staudenmaier A2LA Accreditation Officer II [email protected]

http://www.labqualityconfab.com/wp-content/uploads/STAUDENMAIER.wed_.8am.FINAL_.pdf

Date added: December 30, 2015 - Views: 1

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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.oxfordjournals.org/content/ajcpath/134/3/410.full.pdf

Date added: December 12, 2015 - Views: 2

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10 years of ENAC clinical laboratory accreditation...

Accreditation News Nº 70 10 years of ENAC clinical laboratory accreditation with the ISO 15189 standard All throughout these years ENAC has deployed a wide range of ...

https://www.enac.es/documents/7020/15694/Accreditation_news_70/4c516795-84af-4aaf-a886-b4e70351496a

Date added: April 30, 2016 - Views: 1

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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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XML Schema For Writing ISO 15189: 2007 - EJManager

XML Schema For Writing ISO 15189: 2007 - Compliant SOPs For Clinical Laboratory ... prepared by the laboratory as per guidelines issued 1.by the NABL

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

Date added: December 12, 2013 - Views: 11

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Simplifying ISO 15189 - Thermo Scientific

Simplifying ISO 15189 Make it a PDCA process, not a list! •Don’t think of ISO 15189 as a long list of requirements –Document isn’t organized and ordered to show

https://www.thermoscientific.jp/content/dam/tfs/SDG/CDD/CDD%20Marketing%20Material/webinars/ThermoWebinar6-2015.pdf

Date added: April 4, 2016 - Views: 1

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What is quality management and what is a quality...

What is quality management and what is a quality ... These requirements were recorded in a document and published as the ISO 15189 quality ... also guidelines.

https://extranet.who.int/lqsi/printpdf/334

Date added: May 3, 2016 - Views: 1

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Quality Management in the Laboratory

Quality Management in the Laboratory Ann Shadler, MT ... ISO 15189. QSE According to CLSI ... guidelines to your staff and to external

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

Date added: January 3, 2013 - Views: 90