GOST R ISO 15189-2009
ГОСТ Р ИСО 15189-2009
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Medical laboratories. Particular requirements for quality and competence
Лаборатории медицинские. Частные требования к качеству и компетентности
Status: Not effective - Superseded. Information about registration 297-st dated 04/27/2015 (official website of Rosstandart); (IUS 12-2015)
This standard establishes specific requirements for the quality and competence of medical laboratories. This standard is intended for use by medical laboratories in the development of their quality management systems and the assessment of their own competence, as well as for use by accreditation bodies in confirming or recognizing the competence of medical laboratories
Настоящий стандарт устанавливает частные требования к качеству и компетентности медицинских лабораторий. Настоящий стандарт предназначен для применения медицинскими лабораториями при разработке их систем менеджмента качества и оценке собственной компетентности, а также для использования органами аккредитации при подтверждении или признании компетентности медицинских лабораторий
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Format: Electronic (pdf/doc)
Approved: Federal Agency for Technical Regulation and Metrology,
12/9/2009
SKU: RUSS71585
The Product is Contained in the Following Classifiers:
PromExpert »
SECTION I. TECHNICAL REGULATION »
V Testing and control »
3 Activities of testing laboratories »
3.1 Basic requirements for testing laboratories and their activities »
PromExpert »
SECTION I. TECHNICAL REGULATION »
III Quality »
1 Basic requirements for quality of products and services »
ISO classifier »
11 HEALTH »
11.100 Laboratory preparations »
National standards »
11 HEALTH »
11.100 Laboratory preparations »
ISO classifier »
11 HEALTH »
11.100 Laboratory preparations »
11.100.01 Laboratory drugs in general »
National standards »
11 HEALTH »
11.100 Laboratory preparations »
11.100.01 Laboratory drugs in general »
National Standards for KGS (State Standards Classification) »
Latest edition »
R Health. Sanitation and hygiene items »
R2 Equipment and tools of medical institutions »
R20 Classification, nomenclature and general norms »
The Document is Replaced With:
GOST R ISO 15189-2015: Medical laboratories. Particular requirements for quality and competence
As a Replacement Of:
GOST R ISO 15189-2006: Medical laboratories. Particular requirements for quality and competence
The Document References:
GOST 8.417-2002: State system for ensuring the uniformity of measurements. Units of quantities
GOST R ISO 9000-2008: Quality management systems. Fundamentals and vocabulary
GOST R ISO 9001-2001: Quality management systems. Requirements
GOST R ISO/IEC 17025-2006: General requirements for the competence of testing and calibration laboratories
The Document is Referenced By:
GOST R 55991.1-2014: In vitro diagnostics medical devices. Part 1. Automatic analysers for biochemical assays. Technical requirements for public procurement
GOST R 55991.2-2014: In vitro diagnostics medical devices. Part 2. Automatic analyser for immunoassays. Technical requirements for public procurement
GOST R 55991.3-2014: In vitro diagnostics medical devices. Part 3. Automatic analysers for bimolecular assays. Technical requirements for public procurement
GOST R 55991.4-2014: In vitro diagnostics medical devices. Part 4. Automatic analysers for coagulation tests. Technical requirements for public procurement
GOST R 55991.5-2014: In vitro diagnostics medical devices. Part 5. Automatic analysers for blood gas, metabolite and acid-base balance assessment. Technical requirements for public procurement
GOST R 55991.6-2014: In vitro diagnostics medical devices. Part 6. Automatic analysers for haematology tests. Technical requirements for public procurement
GOST R 55991.7-2014: In vitro diagnostics medical devices. Part 7. Automatic analysers for general clinical tests. Technical requirements for public procurement
GOST R 56395-2015: Medical laboratories. Reduction of errors through risk management and continual improvement
GOST R 8.692-2009: State system for ensuring the uniformity of measurements. Requirements for the competence of providers of proficiency testing for test laboratories by interlaboratory comparisons
GOST R 8.824-2013: State system for ensuring the uniformity of measurements. General requirements for the competence of reference material producers
I 301.0-12: Regulation on certification of experts of testing laboratories engaged in sanitary-epidemiological research, testing, evaluation. Guidelines
I 301.2-12: General requirements for the special training program for experts of testing laboratories who carry out sanitary-epidemiological studies, tests, evaluations. Guidelines
MR 1.2.0074-13: The use of indicators and criteria for violation of the biotransformation of benzene in the body of children for the tasks of hygienic assessments, sanitary-epidemiological investigations and examinations
MR 2.4.8.0076-13: Alimentary prevention of disorders of the antioxidant, conjugation and elimination functions of the glutathione system in children associated with exposure to aromatic hydrocarbons
MUK 4.2.3115-13: Laboratory diagnosis of community-acquired pneumonia
R 50.1.108-2016: ILAC policy on the traceability of measurement results
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