[1] | ISO Guide 30, Terms and definitions used in connection with reference materials |
[2] | ISO 1087-1, Terminology work - Vocabulary - Part 1: Theory and application |
[3] | ISO 3534-1, Statistics - Vocabulary and symbols - Part 1: General statistical terms and terms used in probability |
[4] | ISO 5725-1, Accuracy (trueness and precision) of measurement methods and results - Part 1: General principles and definitions |
[5] | ISO 9000:2005, Quality management systems - Fundamentals and vocabulary |
[6] | ISO 9001:2008, Quality management systems - Requirements |
[7] | ISO 15190, Medical laboratories - Requirements for safety |
[8] | ISO 15194, In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for certified reference materials and the content of supporting documentation |
[9] | ISO/IEC 17011, Conformity assessment - General requirements for accreditation bodies accrediting conformity assessment bodies |
[10] | ISO/IEC 17043:2010, Conformity assessment - General requirements for proficiency testing |
[11] | ISO 19011, Guidelines for auditing management systems |
[12] | ISO/IEC 27001, Information technology - Security techniques - Information security management systems - Requirements |
[13] | ISO 27799, Health informatics - Information security management in health using ISO/IEC 27002 |
[14] | ISO/TS 22367, Medical laboratories - Reduction of error through risk management and continuous improvement |
[15] | ISO 22870:2006, Point-of-care testing (РОСТ) - Requirements for quality and competence |
[16] | ISO/IEC 80000 (all parts), Quantities and units |
[17] | CLSI AUTO08-A: Managing and Validating Laboratory Information Systems; Approved Guideline. CLSI: Wayne, PA., 2006 |
[18] | CLSI AUTO10-A: Autoverification of Clinical Laboratory Test Results; Approved Guideline. CLSI: Wayne, PA., 2006 |
[19] | CLSI C03-A4: Preparation and Testing of Reagent Water in the Clinical Laboratory - Fourth Edition; Approved Guideline. CLSI: Wayne, PA., 2006 |
[20] | CLSI C24-A3: Statistical Quality Control for Quantitative Measurement Procedures: Principles and Definitions - Third Edition; Approved Guideline. CLSI: Wayne, PA: 2006 |
[21] | CLSI C28-A3: Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory - Third Edition; Approved Guideline. CLSI: Wayne, PA., 2008 |
[22] | CLSI C54-A: Verification of Comparability of Patient Results within One Health Care System; Approved Guideline. CLSI: Wayne, PA., 2008 |
[23] | CLSI EP15-A2. User verification of performance for precision and trueness - Second Edition; Approved Guideline. CLSI: Wayne, PA., 2005 |
[24] | CLSI EP17-A: Protocols for Determination of Limits of Detection and Limits of Quantitation; Approved Guideline. CLSI, Wayne PA., 2004 |
[25] | CLSI GP02-A5: Laboratory Documents: Development and Control - Fifth Edition; Approved Guideline. CLSI: Wayne, PA., 2006 |
[26] | CLSI GP09-A: Selecting and Evaluating a Referral Laboratory - Second Edition; Approved Guideline. CLSI: Wayne, PA., 1998 |
[27] | CLSI GP16-A3: Urinalysis - Third Edition; Approved Guideline. CLSI: Wayne, PA., 2009 |
[28] | CLSI GP17-A2: Clinical Laboratory Safety - Second Edition; Approved Guideline. CLSI: Wayne, PA., 2004 |
[29] | CLSI GP18-A2: Laboratory Design - Second Edition; Approved Guideline. CLSI: Wayne, PA., 2007 |
[30] | CLSI GP21-A3; Training and Competence Assessment - Third Edition; Approved Guideline. CLSI: Wayne, PA, 2009 |
[31] | CLSI GP22-A3; Continual Improvement - Third Edition; Approved Guideline. CLSI: Wayne, PA, 2011 |
[32] | CLSI GP26-A4; A Quality Management System Model for Laboratory Services - Fourth Edition - Approved Guideline. CLSI: Wayne, PA, 2011 |
[33] | CLSI GP27-A2; Using Proficiency Testing to Improve the Clinical Laboratory - Second Edition; Approved Guideline. CLSI: Wayne, PA, 2007 |
[34] | CLSI GP29-A2; Assessment of Laboratory Tests When Proficiency Testing is Not Available - Second Edition; Approved Guideline. CLSI: Wayne, PA, 2007 |
[35] | CLSI GP29-A: Assessment of Laboratory Tests When Proficiency Testing is Not Available - Approved Guideline. CLSI: Wayne, PA, 2007 |
[36] | CLSI GP31-A: Laboratory Instrument Implementation, Verification, and Maintenance; Approved Guideline. CLSI: Wayne, PA., 2009 |
[37] | CLSI GP32-A: Management of Nonconforming Laboratory Events; Approved Guideline. CLSI: Wayne, PA., 2007 |
[38] | CLSI GP33-A: Accuracy in Patient Sample Identification; Approved Guideline. CLSI: Wayne, PA., 2010 |
[39] | CLSI GP35-P: Development and Use of Quality Indicators for Process Improvement and Monitoring of Laboratory Quality; Proposed Guideline. CLSI: Wayne, PA., 2009 |
[40] | CLSI GP37-A; Quality Management System: Equipment; Approved Guideline. CLSI: Wayne, PA, 2010 |
[41] | CLSI H03-A6: Procedure for the Collection of Diagnostic Blood Specimens by Venipuncture - Sixth Edition; Approved Standard. CLSI: Wayne, PA., 2007 |
[42] | CLSI H04-A6: Procedures and Devices for the Collection of Diagnostic Capillary Blood Specimens - Sixth Edition; Approved Standard. CLSI: Wayne, PA., 2008 |
[43] | CLSI H18-A4: Procedures for the Handling and Processing of Blood Specimens for Common Laboratory Tests - Fourth Edition; Approved Guideline. CLSI: Wayne, PA, 2009 |
[44] | CLSI H26-A2: Validation, Verification, and Quality Assurance of Automated Hematology Analyzers, Second Edition; Approved Standard. CLSI: Wayne, PA., 2010 |
[45] | CLSI H57-A: Protocol for the Evaluation, Validation, and Implementation of Coagulometers; Approved Guideline. CLSI: Wayne, PA., 2008 |
[46] | CLSI I/LA33-P; Validation of Automated Devices for Immunohematologic Testing Prior to Implementation; Proposed Guideline. CLSI: Wayne, PA., 2009 |
[47] | CLSI M29-A3: Protection of Laboratory Workers from Occupationally Acquired Infections - Third Edition; Approved Guideline. CLSI: Wayne, PA., 2005 |
[48] | CLSI X05-R: Metrological Traceability and Its Implementation; A Report. CLSI: Wayne, PA., 2006 |
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[50] | College of American Pathologists., Quality management in anatomic pathology CAP: Northfield, IL, 2005 |
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[54] | EN 12435:2006 Health informatics - Expression of the results of measurements in health sciences |
[55] | Guidelines for Approved Pathology Collection Centres (2006) NPAAC |
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[67] | Requirements for Pathology Laboratories (2007) National Pathology Accreditation Advisory Council (NPAAC) |
[68] | Requirements for Quality Management in Medical Laboratories (2007) NPAAC |
[69] | Requirements for the Estimation of Measurement Uncertainty (2007) NPAAC |
[70] | Requirements for the Packaging and Transport of Pathology Specimens and Associated Materials (2007) NPAAC |
[71] | Requirements for the Retention of Laboratory Records and Diagnostic Material (2009) NPAAC |
[72] | Requirements for Information Communication (2007) NPAAC |
[73] | Requirements for the Development and Use of In-house In Vitro Diagnostic Devices (2007) NPAAC |
[74] | Requirements for the Packaging and Transport of Pathology Specimens and Associated Materials (2007) NPAAC |
[75] | SNOMED Clinical Terms. International Health Terminology Standards Development Organization (IHTSDO), Copenhagen, Denmark, 2008. http://www.ihtsdo.org |
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УДК 61.003.054:006.354 | ОКС 03.120.10 | Р20 |
11.100.01 | ||
Ключевые слова: медицинская лаборатория, система менеджмента качества, качество клинических лабораторных исследований, компетентность персонала, внешние услуги и поставки, консультативные услуги, разрешение жалоб, идентификация и контроль несоответствий требованиям, корректирующие действия, предупреждающие действия, помещения и условия окружающей среды, оборудование, реагенты и расходные материалы, преаналитические процессы, аналитические процессы, постаналитические процессы, отчеты о результатах, менеджмент лабораторной информации |
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М.: Стандартинформ, 2015