AS ISO 22367:2021
Current
The latest, up-to-date edition.
Medical laboratories - Application of risk management to medical laboratories
Hardcopy , PDF 1 User , PDF 3 Users , PDF 5 Users , PDF 9 Users
English
16-04-2021
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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