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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: 397

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Procedures for Validation of Diagnostic Methods in Clinical ...

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

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

Date added: December 1, 2013 - Views: 17

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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 medical

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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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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Guidance for Laboratory Quality Manuals - QMP–LS

Quality management systems—Guidelines for performance improvements The concept of a quality management system is based on principles described in ISO 9001:2008, Quality ... ISO 15189:2007 (Medical laboratories Particular requirements for quality and competence) are more

http://www.qmpls.org/Portals/0/OLA/PDFs/Master%20-%20OLA%20Guidance%20For%20Lab%20Quality%20Manuals.pdf

Date added: September 16, 2012 - Views: 204

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Beyond CLIA Regulation: Quality Management System ...

guidelines CLSI ISO Comparison of CLSI, ISO and CLIA Questions to consider. ... ISO 15189:2003, continued ISO 15189:2003, continued 1. Personnel 2. Accommodation and environmental conditions 3. Laboratory equipment 4. Pre-examination procedures 5.

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

Date added: December 29, 2011 - Views: 39

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

ISO Guidelines 15189 Medical laboratories – Particular requirements for quality and competence ISO has developed standards for quality systems that have been used to assess specific aspects of health services (ISO 9000 series).

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

Date added: February 9, 2013 - Views: 11

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G601 Guideline for A2LA Medical Laboratory Accreditation

G602 -Guidelines for Implementing the ISO 15189 Requirements These documents are all available on the A2LA website or through the A2LA office. ISO 15189 The laboratory must obtain an official copy of ISO 15189 - Medical Laboratories -

http://www.a2la.org/guidance/Medical_G601.pdf

Date added: April 24, 2012 - Views: 11

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Guidelines for Training Courses for Assessors Used by ...

ISO 15189 Medical Laboratories – Particular requirements for quality and competence ... ISO 19011 Guidelines for quality and/or environmental management systems auditing ILAC-P9 ILAC Policy for Participation in Proficiency Testing Activities

http://www.ilac.org/documents/ILAC_G3_08_2012.pdf

Date added: November 2, 2012 - Views: 15

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REQUIREMENTS FOR QUALITY MANAGEMENT IN MEDICAL LABORATORIES

standards, and initiate and promote guidelines and education programs about pathology tests. Publications produced by NPAAC are issued as accreditation material to provide ... (ISO 15189) for full information on the requirements for review of contracts for medical

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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Guidelines for Developing a Quality Management Plan

Doc1.0-14 Guidelines for Developing a Quality Management Plan Version 1.0 Page 1 of 4 ... with ISO standards (refer to ISO 15189). The 12 QSEs represent the most fundamental elements for maintaining quality, safety, ...

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: 59

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

Guidelines for daily operation ... Road to ISO 15189 Accreditation for St. Sugustine Medical Laboratory Ltd. Author: Administrator Subject: Expert Access January 2009 presentation Keywords: expert access,january 2009,road to iso Created Date:

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

Date added: December 3, 2012 - Views: 20

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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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List of Quality System Standards - 9000 Advisers

ISO 9004 provides guidelines to organizations for performance improvement. It is based on the same quality management principles as ISO 9001. ... ISO 15189 ISO 15189:2003 – Medical laboratories — Particular requirements for quality and

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

Date added: October 19, 2011 - Views: 333

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Frequently Asked Questions Related to the A2LA 15189 Program

1 Frequently Asked Questions Related to the A2LA ISO 15189 Medical Laboratory Accreditation Program ISO and the International Organization for Standardization

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

Date added: January 28, 2014 - Views: 6

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

competence of testing and calibration laboratories, using the ISO standard development guidelines, but using medical terminology. ISO 15189 and ISO/IEC 17025 are ... ISO 15189:2003, and to identify general implications for the quality management

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

Date added: September 10, 2012 - Views: 15

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Pre-Microscopic Examination Specimen Handling Guidelines in ...

International Standard ISO 15189:2007 - Medical Laboratories; section 16 - Pre-examination. Collection and Handling ... Guidelines for the correct fixative to use for each specimen type must be documented and include: o Fixative to be used

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

Date added: July 12, 2013 - Views: 8

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Joint Commission Laboratory Standards and Quality Management ...

By achieving ISO 15189 accreditation, a laboratory demonstrates its willingness to step above CLIA’s minimum quality control and quality assurance-based laboratory requirements to the philosophy of creating an ongoing systematic relationship

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

Date added: February 26, 2012 - Views: 56

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

XML Schema For Writing ISO 15189: 2007 - Compliant SOPs For Clinical Laboratory Examinations Dr Shaileshkumar Patel**, Dr Jigar Saherawala*, ... prepared by the laboratory as per guidelines issued 1.by the NABL For NABL accreditation clinical laboratory must prepare ...

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

Date added: December 12, 2013 - Views: 2

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Revised Policy 2011 03 22 - College of American Pathologists

Guidelines for quality and/or environmental management systems assessment . ISO/IEC 9000:2005. Quality management systems – Fundamentals and vocabulary . ... for ISO 15189 accreditation, and determines accreditation for a laboratory. 6.4.

http://www.cap.org/apps/docs/laboratory_accreditation/15189/cap15189_acc_prog_policies.pdf

Date added: January 5, 2013 - Views: 5

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Ensuring compliance with ISO 15189:2012 – Gap analysis to ...

Ensuring compliance with ISO 15189:2012 – Gap analysis to ISO 15189:2007 As reported in the September 2013 issue Eye on OLA: ... • Reviewing standards of practice in laboratory medicine and recommending guidelines to the OLA accreditation

http://www.qmpls.org/Portals/0/Newsletter/Archive/2013/2013-10-%20QMP-LS%20News%20-%20Print%20Version.pdf

Date added: October 25, 2013 - Views: 14

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Measurement Quality in practice according to recommendations ...

international standards ISO/IEC 17025 or ISO 15189. One can define that we have appropriate measurement quality in place when the client ... important guidelines. Target group. Analytical chemists, laboratory responsible, QA-personal, ...

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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Quality Management for the Medical Laboratory

guidelines, regulations, requirements Advantages –Fast – Local Orientation – Local Expertise – Local Logic Disadvantages ... ISO 15189 requirements Management Requirements 1. Organization 2. Quality Management System 3. Document Control 4.

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

Date added: April 30, 2012 - Views: 84

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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: 38

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MEDICAL LABORATORIES (ISO/IEC 17025 & ISO 15189 )

F 95 Vertical Assessment for ISO 15189 Medical laboratories F 100 Addition Requirements for ISO/IEC 17025:2005 ... TG 05 Guidelines concerning Calibration Intervals and Recalibration TG 17 Guidance Document for Andrology Laboratories . Title: CL-M-10

http://www.sanas.co.za/manuals/pdfs/clm10.pdf

Date added: May 6, 2013 - Views: 3

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National Laboratory Guidelines for Pandemic Influenza

These guidelines will be updated as necessary, as more information becomes available, and are to be used in conjunction with usual laboratory standards AS/NZS 2243.3:2002 and NZS/ISO 15189:2003. 4 National Laboratory Guidelines for Pandemic Influenza

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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GUIDELINES ON TRAINING COURSE FOR LABORATORY AND INSPECTION ...

opinions based on objective facts, etc. ISO 15189 requirements for interpretation of ... APLAC TC 006: Guidance Notes on ISO/IEC 17020 APLAC TC 007: Guidelines for Food Testing Laboratories . Guidelines on Training Course for Assessors – APLAC TR 001

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

Date added: March 27, 2012 - Views: 27

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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 ... Guidelines for Certification Body Accreditation in the field of Risk Based Inspection Management Systems

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

Date added: April 23, 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 Yesim Gurol*, Emine Kurt, ... guidelines of the ministry of health in the related country. Clinical microbiology is mostly based on interpretation

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

Date added: November 25, 2013 - Views: 2

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

guidelines and regulations (hereafter called ‘quality documents’) to improve the quality of laboratory testing, ... ISO 15189 – Medical Laboratories – Particular requirements for quality and competence is the most widely used clinical

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

Date added: May 25, 2013 - Views: 3

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Laboratory Quality Management System - World Health Organization

and on guidelines for implementation of ISO 15189 in diagnostic laboratories developed by CLSI. WHO, CDC and CLSI would like to acknowledge with thanks all those who contributed to the development and review of this training package, more specifically:

http://www.who.int/ihr/training/laboratory_quality/contributors_and_contacts.pdf

Date added: January 18, 2013 - Views: 9

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AS 4633 (ISO 15189) APPLICATION DOCUMENT - QCNet

ISO 15189 APPLICATION DOCUMENT medical testing 1 of 33 medical testing AS 4633 (ISO 15189) APPLICATION DOCUMENT SUPPLEMENTARY REQUIREMENTS FOR ACCREDITATION IN THE FIELD OF ... Guidelines for Approved Pathology Collection Centres Guidelines for Cytogenetics Laboratories

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

Date added: February 9, 2012 - Views: 34

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ILAC Guidelines on Qualifications and Competence of Assessors ...

ISO 19011 Guidelines for quality and/or environmental management systems auditing ISO 5725 Accuracy (Trueness and Precision) of measurement Methods and Results ... ISO 15189 and its application in specific fields of the medical

http://www.ilac.org/documents/ILAC_G11_07_2006_ILAC_guidelines_on_qualifications_and_competence_of_assessors.pdf

Date added: February 7, 2012 - Views: 5

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Laboratory Quality Management System - World Health Organization

Standards, guidelines, and best practices for quality in medical laboratory testing Guidance for quality in manufacturing and service industries. 14 ISO Documents - Laboratory ISO 9001:2000 Quality Management ... ISO 15189:2007 Quality management

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

Date added: May 23, 2013 - Views: 36

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Laboratory Quality Standards - World Health Organization

Laboratory Information Systems. 6. Equipment and Supplies. 7. Guidelines. I. World Health Organization, Regional Office for South-East Asia. II. World Health ... (ISO) 15189 and ISO 17025 have ... International Standards Organization (ISO). ISO/IEC 17025:2005.

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

Date added: May 10, 2013 - Views: 3

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

disseminates consensus standards, guidelines and best practices. Formerly known as the National Committee for Clinical Laboratory Standards (NCCLS). ... ISO 15189:2003 (Medical laboratories Particular requirements for quality and competence) are more

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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Accreditation of clinicalAccreditation of clinical ...

ISO 15189: 2003/2007ISO 15189: 2003/2007 Medical laboratories – Particular requirements for quality and competence The standard for assessment of medical laboratories

http://static.preanalytical-phase.org/parma2011/parma_presentations/17_Wim_Huisman.pdf

Date added: May 11, 2013 - Views: 15

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NEW EDITION OF ISO 15189:2012

Transitional guidelines to ISO 15189:2012 On 1st November 2012 the standard ISO 15189:2012 Medical Laboratories- Requirements for Quality and Competence was published by ISO. International Laboratory Accreditation Co-Operation (ILAC),

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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STR 2.4 SPECIFIC TECHNICAL REQUIREMENTS FOR ACCREDITATION OF ...

(Supplementary to MS ISO 15189) JABATAN STANDARD MALAYSIA Department of Standards Malaysia MOSTI MS ISO 15189 . ... Standards and Guidelines for Nucleic Acid Detection and Analysis 5.5.5 Flow cytometry for haematological applications

http://www.standardsmalaysia.gov.my/documents/10179/427237/STR%202.4%20%28all%20in%29%2C%20Issue%204%2C%2020%20Dec%202012%20-%20EFFECTIVE%20IMPLEMENTATION%20STARTS%20ON%2031%20MARCH%202014.pdf

Date added: May 11, 2013 - Views: 2

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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, and docu- ... ed ISO 15189 certification from the South Africa National Accreditation System (SANAS). In July 2007, before the

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

Date added: August 26, 2013 - Views: 4

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Quality managementin flow cytometry–requirementsofGLP, GMP ...

Germany: Guidelines of the medical association (RiLiBÄK): compulsory, structure adapted to DIN/ISO/EN 15189 2. ... (ISO 15189 4.6.2, 5.3.2), • method validation (ISO 15189 5.5.2), • Laboratory Information System validation, and

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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Lab Guidelines - LabMedicine

ISO 15189:2007 Medical Laboratories—Particular requirements for quality and competence. ... guidelines for the health care and medical testing community through a consensus process that balances the perspectives of industry, government, ...

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

Date added: October 13, 2013 - Views: 2

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PRESENTATION CATALOGUE 2013 - TÜV Rheinland

guidelines); Presentation of the block diagram of a process within a testing/calibration laboratory ... Presentation of the SR EN ISO 15189 standard (the important aspects to consider during the audit are highlighted); presentation of the SR EN

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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EGAC Guidelines on Calculation of Measurement Uncertainty for ...

EGAC Guidelines on Calculation of Measurement Uncertainty ... The standards ISO/IEC 17025:2005 and ISO 15189:2007 specifies detailed requirements concerning the estimation of uncertainty of measurement and how it should be stated in the test reports.

http://www.egac.gov.eg/Upload/InfoCenter/728/PB13L%20-%20Test%20Uncertainty%20Guideline.pdf

Date added: March 12, 2012 - Views: 4

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Decoding ISO 15189™ Take the complexity out of

learn about best practices, develop guidelines or broaden your knowledge, IQMH is your source for proven quality management systems. ISO 15189 Simplified . Decoding ISO 15189™ Modules ... ISO 15189 Simplified The new standard of excellence

https://iqmh.org/LinkClick.aspx?fileticket=HqQJM6%2bEVSk%3d&tabid=192

Date added: May 2, 2013 - Views: 4

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Essentials of Clinical Laboratory Management in Developing ...

Essentials of Clinical Laboratory Management in Developing Regions 6 3. Essential guidelines for Total Quality Management & Accreditation based on ISO 15189

http://www.ifcc.org/media/185572/2008%20-%20C-CLM%20Monograph.pdf

Date added: October 20, 2012 - Views: 8

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2 ASLM Introduction QMS Paul Klatser [.pdf] - Stop TB Partnership

specifications, guidelines or characteristics that can be used consistently to ensure that materials, products, ... ISO 15189 is not laboratory discipline specific. ISO 15189: The international standard for medical laboratory quality and competence .

http://www.stoptb.org/wg/gli/assets/documents/gli_acc_m1/2%20ASLM%20Introduction%20QMS%20Paul%20Klatser.pdf

Date added: March 20, 2013 - Views: 6

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Lab Guidelines - Labmedicine

ISO 15189. Geneva, Switzerland: International Organization for Standardization; 2007. 5. ... guidelines for the health care and medical testing community through a consensus process that balances the perspectives of industry, government, ...

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

Date added: September 25, 2013 - Views: 16

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REVIEW POLICIES, PROCEDURES AND GUIDELINES FOR POINT-OF-CARE ...

be used in conjunction with ISO 15189, Medical laboratories – particular requirements for ... Guidelines based on ISO 22870 ‘Fitness for purpose’ with clinical needs and effectiveness defined. Should only supplement laboratory testing.

http://www.health.gov.au/internet/main/publishing.nsf/Content/025BF865397EB593CA257BF0001A3523/$File/PoCT%20Policies%20and%20Procedures.pdf

Date added: March 22, 2014 - Views: 1