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DD CEN ISO/TS 22367:2010

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

Medical laboratories. Reduction of error through risk management and continual improvement
Available format(s)

Hardcopy , PDF

Superseded date

05-06-2020

Language(s)

English

Published date

04-30-2010

Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Management responsibility in preventive and corrective
   actions, and continual improvement
5 Identification of potential and actual laboratory
   non-conformities, errors and incidents
6 Classification of laboratory non-conformities, errors
   and incidents
7 Preventive action and corrective actions
8 Assessment of risk arising from actual and potential
   laboratory non-conformities
9 Review of collected laboratory non-conformities, errors
   and incidents
10 Preventive action and corrective action plans
11 Preventive action and corrective action plan files
12 Continual improvement plan
Annex A (informative) - Failure modes and effects analysis
Annex B (informative) - Model for assessing risk of harm
Annex C (informative) - Ranking of severity levels
Bibliography

Describes the application of ISO 15189 as a system for reducing laboratory error and improving patient safety by applying the principles of risk management, with reference to examination aspects, especially to pre- and post-examination aspects, of the cycle of laboratory medical care.

Committee
CH/212
DevelopmentNote
Renumbers and supersedes DD ISO/TS 22367. 2010 version incorporates corrigendum to DD ISO/TS 22367. (04/2010)
DocumentType
Standard
Pages
18
PublisherName
British Standards Institution
Status
Superseded
SupersededBy
Supersedes

Standards Relationship
ISO/TS 22367:2008 Identical
CEN ISO/TS 22367:2010 Identical

IEC 61025:2006 Fault tree analysis (FTA)
IEC 60812:2006 Analysis techniques for system reliability - Procedure for failure mode and effects analysis (FMEA)
ISO 15189:2012 Medical laboratories — Requirements for quality and competence
CLSI HS1 A2 : 2ED 2004 A QUALITY MANAGEMENT SYSTEM MODEL FOR HEALTH CARE
ISO/IEC Guide 73:2002 Risk management Vocabulary Guidelines for use in standards
ISO 9000:2015 Quality management systems — Fundamentals and vocabulary
CLSI GP22 A2 : 2ED 2004 CONTINUOUS QUALITY IMPROVEMENT: INTEGRATING FIVE KEY QUALITY SYSTEM COMPONENTS
ISO 14971:2007 Medical devices Application of risk management to medical devices
MIL-STD-1629 Revision A:1980 PROCEDURES FOR PERFORMING A FAILURE MODE, EFFECTS AND CRITICALITY ANALYSIS
CLSI EP18 A : 1ED 2002 QUALITY MANAGEMENT FOR UNIT-USE TESTING

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