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I.S. EN ISO 22367:2020

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by

Medical laboratories - Application of risk management to medical laboratories (ISO 22367:2020)

Available format(s)

Hardcopy , PDF

Superseded date

16-05-2020

Language(s)

English

Published date

07-04-2020

For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.

Only cited Standards give presumption of conformance to New Approach Directives/Regulations.


Dates of withdrawal of national standards are available from NSAI.

€114.00
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Risk management
5 Risk analysis
6 Risk evaluation
7 Risk control
8 Benefit-risk analysis
9 Risk management review
10 Risk monitoring, analysis and control activities
Annex A (informative) Implementation of risk management within the quality management system
Annex B (informative) Developing a risk management plan
Annex C (informative) Risk acceptability considerations
Annex D (informative) Identification of characteristics related to safety
Annex E (informative) Examples of hazards, foreseeable sequences of events and hazardous situations
Annex F (informative) Nonconformities potentially leading to significant risks
Annex G (informative) Risk analysis tools and techniques
Annex H (informative) Risk analysis of foreseeable user actions
Annex I (informative) Methods of risk assessment, including estimation of probability and severity of harm
Annex J (informative) Overall residual risk evaluation and risk management review
Annex K (informative) Conducting a benefit-risk analysis
Annex L (informative) Residual risk(s)
Bibliography

This document specifies a process for a medical laboratory to identify and manage the risks to patients, laboratory workers and service providers that are associated with medical laboratory examinations.

Committee
TC 212
DocumentType
Standard
Pages
100
ProductNote
The date of any NSAI previous adoption may not match the date of its original CEN/CENELEC document. This standard also refers to ISO/TR 24971:2019,ISO 18113:2009
PublisherName
National Standards Authority of Ireland
Status
Superseded
SupersededBy
Supersedes

Standards Relationship
EN ISO 22367:2020 Identical
ISO 22367:2020 Identical

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