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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 ...

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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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 ... and ISO 15189:2007, which emphasize quality management system implementation.

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

Date added: September 16, 2012 - Views: 206

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Beyond CLIA Regulation: Quality Management System ...

International Guidelines & Standards Beyond CLIA Regulation: ... Requirements for Quality and Competence (ISO 15189:2003) Medical Laboratories ... 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: 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 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 Standards in Health Laboratories - WHO | World Health ...

Quality Standards known as ISO/IEC/17025 for all types of testing and calibrating laboratories and more specifically ISO 15189 for ... ISO Guidelines 15189 Medical laboratories – Particular requirements for quality and competence

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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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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G601 Guideline for A2LA Medical Laboratory Accreditation

The American Association for Laboratory Accreditation Document Issued: March 30, 2010 G601 – Guideline for A2LA Medical Laboratory Accreditation

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

Date added: April 24, 2012 - Views: 11

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REQUIREMENTS FOR QUALITY MANAGEMENT IN MEDICAL LABORATORIES

Requirements for Quality Management in Medical Laboratories 3 G .4 Checklist for organisation and management The checklist below is intended as a guide only.

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 Training Courses for Assessors Used by ...

Guidelines for Training Courses for Assessors Used by Accreditation Bodies Page 3 of 17 TABLE OF CONTENTS ... ISO/IEC 17025, ISO 15189, ISO/IEC 17020), not combined. These guidelines are not intended to cover refresher training or technically specific training of veteran assessors.

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

Date added: November 2, 2012 - Views: 15

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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: 61

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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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List of Quality System Standards - 9000 Advisers

List of Quality System Standards ISO 9000, ... ISO 9004 provides guidelines to organizations for performance improvement. It is based ... ISO 15189 ISO 15189:2003 – Medical laboratories — Particular requirements for quality and competence

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

Date added: October 19, 2011 - Views: 335

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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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Joint Commission Laboratory Standards and Quality Management ...

ISO 15189 There is now a burgeoning interest in laboratory accreditation concerning the international laboratory quality management standard, ISO 15189. 2 This standard differs from the U.S. national laboratory regulation, ...

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 general checklist

Pre-Microscopic Examination Specimen Handling Guidelines in ... ... Gap Analysis of ISO 15189:2012 and ISO 15189:2007 in the field of Medical Testing May 2013 Page 6 of 17 Gap analysis of management and technical requirements.

http://www.pdfspath.com/download/iso%2015189%20general%20checklist.pdf

Date added: August 2, 2014 - Views: 1

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

Ensuring compliance with ISO 15189:2012 ... “Noting the results of the ISO ballot completed for ISO FDIS 15189 on 11 October 2012, ... • 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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EVALUATING THE SUCCESS OF IMPLEMENTING ISO 15189:2003 IN A ...

of ISO 15189:2003 (ISO, 2003a) as the standard for medical laboratories, took into account the existing ISO/IEC 17025:1999 (ISO, 1999) standard, as well as ... 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: 16

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Revised Policy 2011 03 22 - College of American Pathologists

The policies in this document (CAP 15189 Policies), govern the CAP 15189 Accreditation Program (Program) of the College of American Pathologists (CAP).

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

XML Schema For Writing ISO 15189: 2007 - Compliant SOPs For Clinical Laboratory ... prepared by the laboratory as per guidelines issued 1.by the NABL ... ISO/IS 15189:2007 and NABL-112 was referred.

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

Date added: December 12, 2013 - Views: 2

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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 – Too introspective ... ISO 15189:2007 Medical Laboratories – particular requirements for quality and competence.

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

Date added: April 30, 2012 - Views: 88

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MEDICAL LABORATORIES (ISO/IEC 17025 & ISO 15189 )

F 29 Generic Checklist for Medical Laboratories – I SO/IEC 17025 ... (ISO/IEC 17025 & ISO 15189 ) CL-M-10 ©SANAS Page 2 of 2 R 04 ... R 74 Guidelines for Interlaboratory Quality Control in Accredited Medical Laboratories

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

Date added: May 6, 2013 - Views: 6

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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: 9

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

Review and comparison of quality standards, guidelines and regulations for laboratories Authors: Tjeerd A.M. Datema1 Linda Oskam1 Paul R. Klatser1,2,3 Affiliations: 1KIT Biomedical Research, ... ISO 15189 – Medical Laboratories – Particular requirements

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

Date added: May 25, 2013 - Views: 3

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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) ... and NATA Technical Note 4, Guidelines for the Quality Management of Microbiological Media should be referred to. Identification Tests/Kits

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

Date added: February 9, 2012 - Views: 34

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GUIDELINES ON TRAINING COURSE FOR LABORATORY AND INSPECTION ...

Guidelines on Training Course for Laboratory and Inspection Body assessors – TR 001 Issue No. 2 Issue Date: 05/08 Page 3 of 48 CONTENTS Page 1 ... 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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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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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: 4

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Laboratory Quality Management System - World Health Organization

Laboratory Quality Management System Training Toolkit – Current Laboratory Practice Series - 2009 ... and on guidelines for implementation of ISO 15189 in diagnostic laboratories developed by CLSI. WHO, ...

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

Date added: January 18, 2013 - Views: 9

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

Quality management systems —Guidelines for performance improvements The concept of a quality management system is based on principles described in ISO 9001:2000, Quality ... 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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Laboratory Quality Management System - World Health Organization

ISO 15189:2007 Quality management in the clinical laboratory ... 25 countries, and on guidelines developed by CLSI for implementing a quality management system in health laboratories Partnership Trainers in national or international settings

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 - WPRO | WHO Western Pacific Region

ISO 19011 Guidelines for quality and/or environmental management system auditing ... to retain the essential components of the ISO 15189 laboratory standards. These are divided into eleven sections: (1) Organization and management (2) ...

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

Date added: May 10, 2013 - Views: 3

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ILAC Guidelines on Qualifications and Competence of Assessors ...

ILAC Guidelines on Qualifications and Competence of Assessors and Technical Experts Page 5 ISO/IEC 17025 General requirement for the competence of testing and ... ISO 19011 Guidelines for quality and/or environmental management ... 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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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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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: 6

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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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NEW EDITION OF ISO 15189:2012

ILAC General Assembly Resolution GA 16.21 Noting the results of the ISO ballot completed for ISO FDIS 15189 on 11 October 2012, the General Assembly agrees that by 1 March 2016, all references to ISO 15189 in accreditation certificates (as

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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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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Lab Guidelines - Labmedicine

Lab Guidelines & Standards . 26. LAB. ... (ISO), the Clinical Laboratory Improvement Amendments, the College of American Pathologists, COLA, and The Joint Commission. ... ISO 15189. Geneva, Switzerland: International Organization for Standardization; 2007. 5.

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

Date added: September 25, 2013 - Views: 16

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EGAC Guidelines on Calculation of Measurement Uncertainty for ...

ISO/IEC 17025 and ISO 15189:2007 allow for a variety of approaches for estimating the uncertainty of measurement in testing: ... G. EA-4/16: 2003 “Guidelines on the expression of Uncertainty in Quantitative Testing”. (see www.european-accreditation.org)

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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PRESENTATION CATALOGUE 2013 - TÜV Rheinland, TUV 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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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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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: 16

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Basic Quality Management Systems

For laboratories around the rest of the world, ISO 15189 is the de facto standard for quality, often directly referenced as the regulatory basis for the laboratory. ... - Practical guide to the CLSI guidelines, ISO standards, CLIA Final Rules as well as

http://www.westgard.com/basic-qms-sample/pdf.htm

Date added: August 8, 2014 - Views: 1

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

In time, ISO 15189 and ISO 9001 will become recognized world-wide as the "accepted standard" of practice for ... Clear guidelines and consistent quality verification for all Programs; Effective and efficient corrective action that will

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

Date added: July 15, 2012 - Views: 8

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Qualitätssicherung im Labor im Wechselfeld von DIN 15189 ...

Guidelines of the medical association (RiLiBÄK): compulsory, structure adapted to DIN/ISO/EN 15189 –Accreditation (DIN/ISO/EN 15189): voluntary, but European Accreditation Law ongoing. Quality management is about documentation

http://gfid-ev.com/presentation/SACK_6IDM_Normen.pdf

Date added: September 15, 2013 - Views: 1