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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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Beyond CLIA Regulation: Quality Management System ...

guidelines CLSI ISO ... CLSI QMS ISO 15189 CLIA QSE Clauses Sections Process control 5.4 Pre-examination procedures 5.5 Examination procedures 5.6 Assuring quality – examination 5.7 Post-examination procedures § 493.1240 - § 493.1249 Pre-analytic

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

Date added: December 29, 2011 - Views: 40

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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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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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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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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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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: 21

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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 22, 2014 - Views: 1

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REQUIREMENTS FOR QUALITY MANAGEMENT IN MEDICAL LABORATORIES

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 15189) covers organisation and management.

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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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 ... ready to be assessed for ISO 15189 standards. Giving score to items in the checklist

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 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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Frequently Asked Questions Related to the A2LA 15189 Program

ISO 15189 Medical Laboratory ... A standard is a document that provides requirements, specifications, guidelines or characteristics that can be used ... ISO 15189 accreditation programs.

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

Date added: January 28, 2014 - Views: 7

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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: 68

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Guidance on the documentation requirements of ISO 9001 :2008

Guidance on the Documentation Requirements of ISO 9001:2008 © ISO 2008 – All rights reserved 1 ISO/TC 176/SC 2/N 525R2 . ... Users are also referred to ISO/TR 10013 . Guidelines for quality management systems documentation. for further guidance.

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

Date added: September 26, 2012 - Views: 502

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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: 6

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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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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.qualitysyria.sy/uploads/Medical_G601.pdf

Date added: June 27, 2014 - Views: 1

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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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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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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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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: 335

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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: 5

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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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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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Antenatal and newborn screening laboratory standards mapped ...

Antenatal and newborn screening laboratory standards mapped to ISO 15189 and these are appropriate schemes G7 The laboratory must use assays for screening and

http://www.screening.nhs.uk/getdata.php?id=17264

Date added: September 15, 2014 - Views: 1

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Quality Management for the Medical Laboratory

ISO 15189:2003 Essentials – CSA ... Laboratory Management Professions Guidelines Committee Standards Development Bodies Accreditation Bodies External Quality Assessment Bodies ... training and experience of several years in a medical laboratory).

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

Date added: April 30, 2012 - Views: 89

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

ISO 22870 was prepared by Technical Committee ISO/TC TC 212, Clinical Laboratory testing and in vitro diagnostic test systems. ISO/DIS 22870 ... 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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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: 12

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

A Practical Guide to Internal Quality Control (IQC) ... For those planning to do ISO 15189 accreditation, you should find, in addition to the guide, ... As defined in the Harmonized Guidelines for Internal Quality Control in Analytical

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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MEDICAL LABORATORIES HOSPITAL UNIVERSITI SAINS MALAYSIA

ISO 15189:2009 is on Medical Laboratory Testing Service by fulfilling MS ISO 9001:2008 ... Guidelines on laboratory construction and design (version 1/2004) College of Pathologist Malaysia Prepared by Approved by Assoc Prof Dr Hasnan Jaafar Dato ...

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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INTERNATIONAL ISO STANDARD 19011 - cnis.gov.cn

INTERNATIONAL STANDARD ISO 19011:2011(E) Guidelines for auditing management systems 1 Scope This International Standard provides guidance on auditing management systems, including the principles of

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

Date added: September 27, 2012 - Views: 542

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

for formulating specific guidelines criteria for medical laboratories. He has contributed significantly towards the preparation of NABL ... Mar 2014 Brochure -ISO 15189:2012 (Jun 25 - 28, 2014) ISO 15189:2012 v 1.0 11. Some Comments from participants of

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

Date added: August 17, 2014 - 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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Regional Guidelines for Establishment of Accreditation for.

Guidelines on Establishment of Accreditation of Health Laboratories ... ISO 15189 for medical laboratories in order to eventually achieve the international standard. The most important part of formulating national standards is to get the

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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Akkreditointitoiminnan vaatimukset, arviointiperiaatteet ja ...

SFS-EN ISO 15189:2013 Lääketieteelliset laboratoriot. ... EA-4/02 M:2013 . Evaluation of the Uncertainty of Measurement in Calibration . ... EA Guidelines on the Use of EN 45 011 and ISO/IEC 17021 for Certification to EN ISO 3834 .

http://www.finas.fi/documents/upload/finas_tiedote_10_su_ru_en.pdf

Date added: February 10, 2013 - Views: 2

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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: 18

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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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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 Quality Assurance of the German Medical

http://www.instandev.de/uploads/tx_nfextsymposdownloads/04-Zeichhardt.pdf

Date added: July 9, 2012 - Views: 1

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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 accreditation status. 5. General ... MS ISO 15189 MEDICAL TESTING SAMM NO. 000 . Policy on the Use of SAMM Accreditation Symbol and Combined ILAC MRA Mark or Reference to SAMM

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

Date added: September 27, 2014 - Views: 1

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Lab Guidelines

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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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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ISO 15189 Medical Laboratory Accreditation Workshop and ...

n Identify CLSI and ISO guidelines that describe risk management. ... 9:45 am to noon The Benefits of ISO 15189 Accreditation Chinu Jani, SC(ASCP), VP/GM ... phD joined Bio-Rad Laboratories in early 2009 where he serves as Manager of Advanced Statistical Research in Bio-Rad’s Quality Systems ...

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

Date added: March 31, 2012 - Views: 4

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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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Guidelines Nucleic Acid-Based Diagnostic Procedures

Guidelines for Accreditation of Swiss Medical Laboratories Performing Nucleic Acid-Based Diagnostic Procedures Document No. 323.ew ... [ISO 15189, 5.6.5] Whenever a formal interlaboratory comparison programme is not available, the medical labora-

http://www.seco.admin.ch/sas/00032/00069/00175/index.html?lang=de&download=NHzLpZeg7t,lnp6I0NTU042l2Z6ln1acy4Zn4Z2qZpnO2Yuq2Z6gpJCDdH94fGym162epYbg2c_JjKbNoKSn6A--

Date added: October 30, 2013 - Views: 2

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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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Guidance for Laboratory Quality Manuals

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/LinkClick.aspx?fileticket=V5Gc6ZiaUQs%3d&tabid=109

Date added: October 5, 2013 - Views: 5

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PRESS RELEASE CONTACT INFORMATION: FOR IMMEDIATE RELEASE ...

guidelines published by the CDC (CS242576-A) related to waived testing. Although A2LA does not accredit laboratories ... ISO 15189:2012 and recognition by CMS for the accreditation of clinical laboratories to the CLIA requirements. This results

https://www.a2la.org/press_releases/2014_08_08_Clinical_Program_Update_Waived_Testing_Press_Release.pdf

Date added: October 22, 2014 - Views: 1