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Medical laboratories - Application of risk management to medical laboratories

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Hardcopy , PDF 1 User , PDF 3 Users , PDF 5 Users , PDF 9 Users

Language(s)

English

Published date

16-04-2021

Publisher

Standards Australia

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Identically adopts ISO 22367:2020, which specifies a process for a medical laboratory to identify and manage the risks associated with medical laboratory examinations. The process includes identifying, estimating, evaluating, controlling and monitoring the risks. KEYWORDS: Risk management; Medical laboratory; Clinical; Patients

Committee	HE-029
DocumentType	Standard
ISBN	978 1 76113 273 5
Pages	83
PublisherName	Standards Australia
Status	Current

Standards	Relationship
ISO 22367:2020	Identical

First published as AS ISO 22367:2021.

ISO 15190:2003	Medical laboratories Requirements for safety
ISO 14971:2019	Medical devices Application of risk management to medical devices
ISO Guide 73:2009	Risk management — Vocabulary
ISO/IEC Guide 51:1999	Safety aspects Guidelines for their inclusion in standards
ISO 18113-5:2009	In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 5: In vitro diagnostic instruments for self-testing
ISO 31000:2009	Risk management Principles and guidelines
ISO/TR 24971:2020	Medical devices Guidance on the application of ISO 14971
ISO 9000:2015	Quality management systems — Fundamentals and vocabulary
ISO/TS 22367:2008	Medical laboratories Reduction of error through risk management and continual improvement
ISO 20916:2019	In vitro diagnostic medical devices — Clinical performance studies using specimens from human subjects — Good study practice
ISO 15189:2012	Medical laboratories — Requirements for quality and competence
IEC 61025:2006	Fault tree analysis (FTA)
ISO/IEC Guide 99:2007	International vocabulary of metrology Basic and general concepts and associated terms (VIM)
ISO 18113-2:2009	In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 2: In vitro diagnostic reagents for professional use
IEC 60601-1:2005	Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
ISO 18113-1:2009	In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions and general requirements
ISO 13485:2016	Medical devices Quality management systems Requirements for regulatory purposes
IEC 60812:2006	Analysis techniques for system reliability - Procedure for failure mode and effects analysis (FMEA)
ISO 18113-3:2009	In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 3: In vitro diagnostic instruments for professional use
IEC 62366-1:2015	Medical devices - Part 1: Application of usability engineering to medical devices
ISO 18113-4:2009	In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 4: In vitro diagnostic reagents for self-testing

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AS ISO 22367:2021

Current

Abstract

General Product Information

International Equivalents

History

Standards Referenced By This Book

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