Bibliography - DataMizer ISO15189
ISO15189:2022
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[1] ISO 9000:2015, Quality management systems — Fundamentals and vocabulary
[2] ISO 9001:2015, Quality management systems — Requirements
[3] ISO 15190, Medical laboratories — Requirements for safety
[4] 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
[5] ISO 15198:2004, Clinical laboratory medicine — In vitro diagnostic medical devices — Validation of user quality control procedures by the manufacturer
[6] ISO/IEC 17011, Conformity assessment — Requirements for accreditation bodies accrediting conformity assessment bodies
[7] ISO/IEC 17021-1:2015, Conformity assessment — Requirements for bodies providing audit and certification of management systems — Part 1: Requirements
[8] ISO 17034, General requirements for the competence of reference material producers
[9] ISO/IEC 17043:2010, Conformity assessment — General requirements for proficiency testing
[10] ISO 17511:2020, In vitro diagnostic medical devices — Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples
[11] ISO 18113-1:2009, In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions and general requirements
[12] ISO 19011, Guidelines for auditing management systems
[13] ISO 20658, Medical laboratories — Requirements for collection and transport of samples
[14] ISO TS 20914:2019, Medical laboratories — Practical guide for the estimation of measurement uncertainty
[15] ISO 22367:2020, Medical laboratories — Application of risk management to medical laboratories
[16] ISO TS 22583:2019, Guidance for supervisors and operators of point-of-care testing equipment
[17] ISO 22870, Point-of-care testing (POCT) — Requirements for quality and competence
[18] ISO/IEC 27001:2013, Information technology — Security techniques — Information security management systems — Requirements
[19] ISO 35001, Biorisk management for laboratories and other related organisations
[20] ISO 5725-1:1994, Accuracy (trueness and precision) of measurement methods and results — Part 1:General principles and definitions
[21] ISO 20186-1:2019, Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for venous whole blood — Part 1: Isolated cellular RNA
[22] ISO 20186-2:2019
1) Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for venous whole blood — Part 2: Isolated genomic DNA2) First edition under preparation (previous edition was a Technical Specification). Stage at the time of publication:ISO/DIS 20658:2022.3) To be withdrawn upon publication of this document.
[23] ISO 20186-3:2019, Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for venous whole blood — Part 3: Isolated circulating cell free DNA from plasma
[24] ISO 20166-1:2018, Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue — Part 1: Isolated RNA
[25] ISO 20166-2:2018, Molecular in vitro diagnostic examinations — Specifications for preexaminations processes for formalin-fixed and paraffin-embedded (FFPE)
tissue — Part 2: Isolatedproteins
[26] ISO 20166-3:2018, Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue — Part 3: Isolated DNA
[27] ISO 20166-4:2021, Molecular in vitro diagnostic examinations — Specifications for preexamination processes for formalin-fixed and paraffin-embedded (FFPE) tissue — Part 4: In situ detection techniques
[28] ISO 20184-1:2018, Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for frozen tissue — Part 1: Isolated RNA
[29] ISO 20184-2:2018, Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for frozen tissue — Part 2: Isolated proteins
[30] ISO 20184-3:2021, Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for frozen tissue — Part 3: Isolated DNA
[31] ISO 4307, Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for saliva — Isolated human DNA
[32] ISO 23118, Molecular in vitro diagnostic examinations — Specifications for pre-examination processes in metabolomics in urine, venous blood serum and plasma
[33] SI Brochure, The International System of Units (SI), BIPM (h t t p :// www .bipm .org/ en/ publications/si brochure/ )
[34] CASCO QS-CAS-PROC/33, Common elements in ISO/CASCO Standards 2020
[35] CLSI Planning for Laboratory Operations During a Disaster; Approved Guideline, CLSI document GP36-A. Wayne, PA: Clinical and Laboratory Standards Institute; 2014
[36] Joint BIPM, OIML, ILAC and ISO declaration on metrological traceability, 2011 (h t t p :// www .bipm.org/ utils/ common/ pdf/ BIPM OIML ILAC ISO _joint _declaration _2011 .pdf)
[37] Joint Commission for Guides in Metrology (JCGM) International vocabulary of metrology — Basic and general concepts and associated terms (VIM) 3 edition
[38] International Laboratory Accreditation Cooperation (ILAC). h t t p s :// ilac .org/
[39] Logical Observation Identifiers Names and Codes (LOINC and Nomenclature for Properties and Units (NPU, NGC) and SNOMED CT (h t t p s :// loinc .org)
