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CEN ISO/TS 22367:2010

Withdrawn
Withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

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withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

Medical laboratories - Reduction of error through risk management and continual improvement (ISO/TS 22367:2008, including Cor 1:2009)
Withdrawn date

03-11-2023

Published date

01-27-2010

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

ISO/TS 22367:2008 characterizes 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. ISO/TS 22367:2008 proposes a methodology for finding and characterizing medical laboratory error that would be avoided with the application of ISO 15189.

Committee
CEN/TC 140
DocumentType
Technical Specification
PublisherName
Comite Europeen de Normalisation
Status
Withdrawn
SupersededBy

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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