CEN/TR 15592:2007

Health services - Quality management systems - Guide for the use of EN ISO 9004:2000 in health services for performance improvement

This International Standard provides guidelines beyond the requirements given in ISO 9001 in order to consider both the effectiveness and efficiency of a quality management system, and consequently the potential for improvement of the performance of an organization. When compared to ISO 9001, the objectives of customer satisfaction and product quality are extended to include the satisfaction of interested parties and the performance of the organization.
This International Standard is applicable to the processes of the organization and consequently the quality management principles on which it is based can be deployed throughout the organization. The focus of this International Standard is the achievement of ongoing improvement, measured through the satisfaction of customers and other interested parties.
This International Standard consists of guidance and recommendations and is not intended for certification, regulatory or contractual use, nor as a guide to the implementation of ISO 9001.
This Technical Report provides assistance on how the EN ISO 9004:2000 guidelines may be applied to health services, without prescribing the activities that need to be done by the health service provider; the latter should use its own professional knowledge and/or follow guidelines and protocols established by relevant professional bodies.
Even though EN ISO 9004:2000 promotes a better understanding of the EN ISO 9001:2000 requirements, its scope goes further than that. It is a technical document for managers and process owners to monitor and improve organisation performance, minimise risks, reduce costs, satisfy customers and improve competitiveness.
To fulfil the requirements of processes that have impact on patient safety this Technical Report provides an approach for improvement of risk management in the organisation.
An important value of EN ISO 9004:2000 is that it can be used for self-assessment (see Annex A) comparing the performance of the organisation with the 290 in

Dienstleistungen in der Gesundheitsversorgung - Qualitätsmanagementsysteme - Leitfaden für die Anwendung der EN ISO 9004:2000 auf die Dienstleistungen in der Gesundheitsversorgung zur Leistungsverbesserung

Diese Internationale Norm gibt über die in ISO 9001 enthaltenen Anforderungen hinausgehende Anleitungen, um sowohl die Wirksamkeit als auch die Effizienz eines Qualitätsmanagementsystems und damit die Möglichkeiten der Leistungsverbesserung einer Organisation zu berücksichtigen. Im Vergleich zu ISO 9001 werden die Ziele der Kundenzufriedenheit und der Produktqualität ausgeweitet, um auch die Zufriedenheit interessierter Parteien und die Leistung der Organisation einzubeziehen.
Diese Internationale Norm ist anwendbar auf die Prozesse der Organisation, so dass die zu Grunde liegenden Grundsätze des Qualitätsmanagements in der gesamten Organisation angewandt werden können. Schwer¬punkt dieser Internationalen Norm ist die Erzielung fortschreitender Verbesserungen, gemessen an der Zufriedenheit der Kunden und anderer interessierter Parteien.
Diese Internationale Norm bietet Anleitungen und Empfehlungen und ist weder für die Zertifizierung, behördli¬che oder vertragliche Zwecke vorgesehen noch als Leitfaden zur Umsetzung von ISO 9001.
Dieser Technische Bericht bietet Unterstützung dabei, wie die Richtlinien der EN ISO 9004:2000 auf Dienstleistungen in der Gesundheitsversorgung angewendet werden können, ohne die Aktivitäten vorzuschreiben, die von dem Anbieter der Dienstleistung durchzuführen sind; der Anbieter sollte sein eigenes Fachwissen nutzen und/oder die von den zuständigen Fachkörperschaften festgelegten Anleitungen und Protokolle einhalten.
Wenn auch EN ISO 9004:2000 ein besseres Verständnis der Anforderungen von EN ISO 9001:2000 fördert, geht deren Anwendungsbereich darüber hinaus. Es handelt sich um ein technisches Dokument für Manager und Prozessinhaber, um die Leistung der Organisation zu überwachen und zu verbessern, Risiken zu minimieren, Kosten zu reduzieren, Kunden zufrieden zu stellen und die Wettbewerbsfähigkeit zu verbessern.

Services en santé - Systèmes de management de la qualité - Guide d'utilisation de l'EN ISO 9004:2000 pour l'amélioration continue des performances dans les services en santé

Zdravstvene storitve – Sistemi vodenja kakovosti – Vodilo za uporabo EN ISO 9004:2000 za izboljšanje izvajanja zdravstvenih storitev

General Information

• Status: Published
• Publication Date: 08-May-2007
• ICS: 03.120.10 - Quality management and quality assurance
• ICS: 11.020 - Medical sciences and health care facilities in general
• ICS: 11.020.01 - Quality and environmental management in health care
• ICS: 11.020.10 - Health care services in general
• Technical Committee: CEN/TC 362 - Project Committee - Healthcare services - Quality management systems
• Drafting Committee: CEN/TC 362 - Project Committee - Healthcare services - Quality management systems
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 09-May-2007
• Completion Date: 09-May-2007
• Ref Project: SIST-TP CEN/TR 15592:2007 - Health services - Quality management systems - Guide for the use of EN ISO 9004:2000 in health services for performance improvement

Standards Content (Sample)

SLOVENSKI STANDARD
01-junij-2007
Zdravstvene storitve – Sistemi vodenja kakovosti – Vodilo za uporabo EN ISO
9004:2000 za izboljšanje izvajanja zdravstvenih storitev
Health services - Quality management systems - Guide for the use of EN ISO 9004:2000
in health services for performance improvement
Dienstleistungen in der Gesundheitsversorgung - Qualitätsmanagementsysteme -
Leitfaden für die Anwendung der EN ISO 9004:2000 auf die Dienstleistungen in der
Gesundheitsversorgung zur Leistungsverbesserung
Services en santé - Systemes de management de la qualité - Guide d'utilisation de l'EN
ISO 9004:2000 pour l'amélioration continue des performances dans les services en
santé
Ta slovenski standard je istoveten z: CEN/TR 15592:2007
ICS:
03.100.70 Sistemi vodenja Management systems
11.020.01 Vodenje kakovosti in Quality and environmental
ravnanje z okoljem v management in health care
zdravstvu
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

TECHNICAL REPORT
CEN/TR 15592
RAPPORT TECHNIQUE
TECHNISCHER BERICHT
May 2007
ICS 03.120.10; 11.020
English Version
Health services - Quality management systems - Guide for the
use of EN ISO 9004:2000 in health services for performance
improvement
Services en santé - Systèmes de management de la Dienstleistungen in der Gesundheitsversorgung -
qualité - Guide d'utilisation de l'EN ISO 9004:2000 pour Qualitätsmanagementsysteme - Leitfaden für die
l'amélioration continue des performances dans les services Anwendung der EN ISO 9004:2000 auf die
en santé Dienstleistungen in der Gesundheitsversorgung zur
Leistungsverbesserung
This Technical Report was approved by CEN on 8 April 2007. It has been drawn up by the Technical Committee CEN/SS F20.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, 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: rue de Stassart, 36  B-1050 Brussels
© 2007 CEN All rights of exploitation in any form and by any means reserved Ref. No. CEN/TR 15592:2007: E
worldwide for CEN national Members.

Contents Page
Foreword.4
Introduction .6
0.1 General.6
0.2 Process approach.8
0.3 Relationship with EN ISO 9001.9
0.4 Compatibility with other management systems .10
1 Scope.10
2 Normative references.11
3 Terms and definitions .11
4 Quality management system.23
4.1 Managing systems and processes .23
4.2 Documentation.23
4.3 Use of quality management principles.26
5 Management responsibility.29
5.1 General guidance.29
5.1.1 Introduction.29
5.1.2 Issues to be considered.30
5.2 Needs and expectations of interested parties .31
5.2.1 General.31
5.2.2 Needs and expectations.31
5.2.3 Statutory and regulatory plans.33
5.3 Quality policy.33
5.4 Planning.34
5.4.1 Quality objectives.34
5.4.2 Quality planning.35
5.5 Responsibility, authority and communication.36
5.5.1 Responsibility and authority .36
5.5.2 Management representative.36
5.5.3 Internal communication.36
5.6 Management review.37
5.6.1 General.37
3.6.2 Review input.37
5.6.3 Review output.38
6 Resource management.38
6.1 General guidance.38
6.1.2 Issues to be considered.39
6.2 Human resources.39
6.2.3 Involvement of people.39
6.2.2 Competence, awareness and training .40
6.3 Infrastructure.41
6.4 Work environment.41
6.5 Information.42
6.6 Suppliers and partnerships .42
6.7 Natural resources.43
6.8 Financial resources.43
7 Product realisation.44
7.1 General guidance.44
7.1.1 Introduction.44
7.1.2 Issues to be considered.44
7.1.3. Managing processes.45
7.2 Process related to interested parties .48
7.3 Design and development.49
7.3.1 Design and development planning.49
7.3.2 Design and development input and output .51
7.3.3 Design and development review.52
7.4 Purchasing.53
7.4.1 Purchasing process.53
7.4.2 Supplier control process .54
7.5 Production and service operations .55
7.5.1 Operation and realization .55
7.5.2 Identification and traceability.56
7.5.3 Customer property.57
7.5.4 Preservation of product.57
7.6 Control of monitoring and measuring devices.58
8 Measurement, analysis and improvement.58
8.1 General guidance.58
8.1.1 Introduction.58
8.1.2 Issues to be considered.59
8.2 Measurement and monitoring .60
8.2.1 Measurement and monitoring of system performance .60
8.2.2 Measurement and monitoring of processes.63
8.2.3 Measurement and monitoring of products .63
8.2.4 Measurement and monitoring the satisfaction of interested parties.64
8.3 Control of non-conformity.65
8.3.1 General.65
8.3.2 Nonconformity review and disposition.66
8.4 Analysis of data .67
8.5 Improvement.67
8.5.1 General.67
8.5.2 Corrective action.68
8.5.3 Loss prevention.69
8.5.4 Continual impr
...