CEN ISO/TS 22367:2010

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

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.

Medizinische Laboratorien - Fehlerverringerung durch Risikomanagement und ständige Verbesserung (ISO/TS 22367:2008, einschließlich Cor 1:2009)

Die vorliegende Technische Spezifikation charakterisiert die Anwendung von ISO 15189 als ein System zur Verringerung von Laborfehlern und zur Verbesserung der Patientensicherheit durch Anwendung der Prinzi-pien des Risikomanagements unter Bezugnahme auf Untersuchungsaspekte, insbesondere auf prä- und postanalytische Aspekte, des Zyklus der labormedizinischen Versorgung. Diese Technische Spezifikation schlägt eine Methodologie zum Finden und Charakterisieren von Fehlern medizinischer Laboratorien vor, die durch die Anwendung von ISO 15189 vermieden werden würden.

Laboratoires médicaux - Réduction d'erreurs par gestion du risque et amélioration continue (ISO/TS 22367:2008, Cor 1:2009 inclus)

Medicinski laboratoriji - Zmanjšanje števila napak z obvladovanjem tveganja in stalnim izboljševanjem (ISO/TS 22367:2008, vključno s popravkom Cor 1:2009)

Ta tehnična specifikacija določa uporabo ISO 15189 kot sistem za zmanjšanje števila laboratorijskih napak in izboljševanje varnosti bolnikov z uporabo načel obvladovanja tveganja v zvezi z vidiki preiskovanja, predvsem z vidiki pred in po preiskavi, cikla laboratorijske zdravstvene oskrbe. Ta tehnična specifikacija predlaga metodologijo za ugotavljanje in določanje napak v medicinskih laboratorijih, ki se jim lahko izognemo z uporabo ISO 15189.

General Information

• Status: Withdrawn
• Publication Date: 26-Jan-2010
• Withdrawal Date: 10-Mar-2020
• ICS: 11.100.01 - Laboratory medicine in general
• Technical Committee: CEN/TC 140 - In vitro diagnostic systems
• Drafting Committee: CEN/TC 140 - In vitro diagnostic systems
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Completion Date: 11-Mar-2020
• Ref Project: SIST-TS CEN ISO/TS 22367:2010 - Medical laboratories - Reduction of error through risk management and continual improvement (ISO/TS 22367:2008, including Cor 1:2009)

Relations

• Replaced By: EN ISO 22367:2020 - Medical laboratories - Application of risk management to medical laboratories (ISO 22367:2020)
• Effective Date: 24-Mar-2020

Standards Content (Sample)

SLOVENSKI STANDARD
SIST-TS CEN ISO/TS 22367:2010
01-junij-2010
0HGLFLQVNLODERUDWRULML=PDQMãDQMHãWHYLODQDSDN]REYODGRYDQMHPWYHJDQMDLQ
VWDOQLPL]EROMãHYDQMHP,6276YNOMXþQRVSRSUDYNRP&RU
Medical laboratories - Reduction of error through risk management and continual
improvement (ISO/TS 22367:2008, including Cor 1:2009)
Medizinische Laboratorien - Fehlerverringerung durch Risikomanagement und ständige
Verbesserung (ISO/TS 22367:2008, einschließlich Cor 1:2009)
Laboratoires médicaux - Réduction d'erreurs par gestion du risque et amélioration
continue (ISO/TS 22367:2008, Cor 1:2009 inclus)
Ta slovenski standard je istoveten z: CEN ISO/TS 22367:2010
ICS:
03.100.01 Organizacija in vodenje Company organization and
podjetja na splošno management in general
11.100.01 Laboratorijska medicina na Laboratory medicine in
splošno general
SIST-TS CEN ISO/TS 22367:2010 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------

SIST-TS CEN ISO/TS 22367:2010

---------------------- Page: 2 ----------------------

SIST-TS CEN ISO/TS 22367:2010


TECHNICAL SPECIFICATION
CEN ISO/TS 22367

SPÉCIFICATION TECHNIQUE

TECHNISCHE SPEZIFIKATION
January 2010
ICS 11.100.01
English Version
Medical laboratories - Reduction of error through risk
management and continual improvement (ISO/TS 22367:2008,
including Cor 1:2009)
Laboratoires médicaux - Réduction d'erreurs par gestion du Medizinische Laboratorien - Fehlerverringerung durch
risque et amélioration continue (ISO/TS 22367:2008, Cor Risikomanagement und ständige Verbesserung (ISO/TS
1:2009 inclus) 22367:2008, einschließlich Cor 1:2009)
This Technical Specification (CEN/TS) was approved by CEN on 4 January 2010 for provisional application.

The period of validity of this CEN/TS is limited initially to three years. After two years the members of CEN will be requested to submit their
comments, particularly on the question whether the CEN/TS can be converted into a European Standard.

CEN members are required to announce the existence of this CEN/TS in the same way as for an EN and to make the CEN/TS available
promptly at national level in an appropriate form. It is permissible to keep conflicting national standards in force (in parallel to the CEN/TS)
until the final decision about the possible conversion of the CEN/TS into an EN is reached.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland,
Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.






EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2010 CEN All rights of exploitation in any form and by any means reserved Ref. No. CEN ISO/TS 22367:2010: E
worldwide for CEN national Members.

---------------------- Page: 3 ----------------------

SIST-TS CEN ISO/TS 22367:2010
CEN ISO/TS 22367:2010 (E)
Contents Page
Foreword .3

2

---------------------- Page: 4 ----------------------

SIST-TS CEN ISO/TS 22367:2010
CEN ISO/TS 22367:2010 (E)
Foreword
The text of ISO 22367:2008, including Cor 1:2009 has been prepared by Technical Committee ISO/TC 212
“Clinical laboratory testing and in vitro diagnostic test systems” of the International Organization for
Standardization (ISO) and has been taken over as CEN ISO/TS 22367:2010 by Technical Committee
CEN/TC 140 “In vitro diagnostic medical devices” the secretariat of which is held by DIN.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to announce this Technical Specification: Austria, Belgium, Bulgaria, Croatia, Cyprus,
Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy,
Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia,
Spain, Sweden, Switzerland and the United Kingdom.
Endorsement notice
The text of ISO 22367:2008, including Cor 1:2009 has been approved by CEN as a CEN ISO/TS 22367:2010
without any modification.

3

---------------------- Page: 5 ----------------------

SIST-TS CEN ISO/TS 22367:2010

---------------------- Page: 6 ----------------------

SIST-TS
...