I.S. EN ISO 22367:2020&LC:2020
Current
The latest, up-to-date edition.
Medical laboratories - Application of risk management to medical laboratories (ISO 22367:2020)
Hardcopy , PDF
English
15-05-2020
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.
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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 |
102
|
| ProductNote |
The date of any NSAI previous adoption may not match the date of its original CEN/CENELEC document.
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| ISO 22367:2020 | Identical |
| EN ISO 22367:2020 | Identical |
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