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 - 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

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

General Information

Status
Published
Publication Date
23-May-2007
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
06-Apr-2007
Due Date
11-Jun-2007
Completion Date
24-May-2007

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SLOVENSKI STANDARD
SIST-TP CEN/TR 15592:2007
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
SIST-TP CEN/TR 15592:2007 en,de

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST-TP CEN/TR 15592:2007
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SIST-TP CEN/TR 15592:2007
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.
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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

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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 improvement of the organisation.....................................................................................69

Annex A (informative .........................................................................................................................................72

A.1 Introduction ...............................................................................................................................................72

A.2 Performance maturity levels....................................................................................................................72

A.3 Self-assessment questions......................................................................................................................73

A.4 Documentation of self-assessment results ...........................................................................................82

A.5 Linking potential benefits of ISO 9004 to self-assessment..................................................................83

Annex B (informative) Process for continual improvement .........................................................................86

Bibliography......................................................................................................................................................88

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Foreword

This document (CEN/TR 15592-1:2007) has been prepared by CEN/BT/TF 142 “Healthcare service - Quality

management systems“, the secretariat of which is held by SIS.
Layouts of this document:
Grey-shaded black text is the original EN ISO 9004:2000.
Black italic text is material take from CEN/TS 15224.

Black normal text is the guidance offered in this document for implementing EN ISO 9004:2000.

ISO (the International Organisation for Standardization) is a worldwide federation of national standards bodies

(ISO member bodies). The work of preparing International Standards is normally carried out through ISO

technical committees. Each member body interested in a subject for which a technical committee has been

established has the right to be represented on that committee. International organisations, governmental and

non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the

International Electro-technical Commission (IEC) on all matters of electro technical standardization.

International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 3. Draft

International Standards adopted by the technical committees are circulated to the member bodies for voting.

Publication as an International Standard requires approval by at least 75 % of the member bodies casting

a vote. Attention is drawn to the possibility that some of the elements of this International Standard may be the

subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights.

International Standard ISO 9004 was prepared by Technical Committee ISO/TC 176, Quality management

and quality assurance, Subcommittee SC 2, Quality systems. This second edition of ISO 9004 cancels and

replaces ISO 9004-1:1994, which has been technically revised. The title has been modified to reflect the

comprehensiveness of the quality management system. Many of the existing International Standards within

the ISO 9000 family will be reviewed for withdrawal, or for re-issue as Technical Reports, as many of their

provisions are incorporated into this International Standard. In comparison to previous editions, ISO 9001 and

ISO 9004 now form a consistent pair of standards on quality management. ISO 9001 aims to give quality

assurance of product and to enhance customer satisfaction, while ISO 9004 uses a broader perspective of

quality management to give guidance for performance improvement. Annexes A and B of this International

Standard are for information only.

This Technical Report is intended to provide a guide for applying EN ISO 9004:2000 in health service

organisations by stating appropriate comments and examples in order to clarify the text of the

EN ISO 9004:2000 standard by using health sector specific terminology. This guide is intended to form a

consistent pair with CEN/TS 15224 “Health services — Quality management systems — Guide for the use of

EN ISO 9001:2000 which is a guide for the interpretation and implementation of EN ISO 9001:2000 in the

health service sector which has been recently prepared by CEN/BT/TF 142.

The Technical Specification takes the actual practice of the health care service sector as its clause of

departure. It specifies how organisations in the European health care service sector may interpret and apply

the requirements of the EN ISO 9001:2000 standard when developing and implementing a quality

management system. The CEN/TS 15224 “Health services — Quality management systems — Guide for the

use of EN ISO 9001:2000 is applicable to all health service organisations regardless of structure, owner, size,

type of service provided, locally used approaches or location.

This Technical Report as a guide to EN ISO 9004:2000 implementation in health services takes into account

providing a framework for managing risk in the health sector. Risk management aspects are therefore

emphasized in the guidance. The ISO-IWA 1 version 2, the Spanish UNE 66174:2003, the United Kingdom

HQS International Standards and the Australian and New Zealand Guidelines for Managing Risk in the Health

services Sector have been used as reference documents (see Bibliography).
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This Technical Report cannot be used for third party certification. This document is aimed to be used by

organisations that already have implemented a quality management system according to EN ISO 9001:2000

using CEN/TS 15224:2005. It should be used for continuously improving a quality management system

compliant with EN ISO 9001:2000 applied to health service organisations.
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Introduction
0.1 General

The adoption of a quality management system should be a strategic decision by the top management of an

organisation. The design and implementation of an organisation's quality management system is influenced

by varying needs, particular objectives, the products provided, the processes employed and the size and

structure of the organisation. This International Standard is based on eight quality management principles.

However, it is not the intent of this International Standard to imply uniformity in the structure of quality

management systems or uniformity of documentation.
The purpose of an organisation is

— to identify and meet the needs and expectations of its customers and other interested parties (people in

the organisation, suppliers, owners, society), to achieve competitive advantage, and to do this in an effective

and efficient manner, and

— to achieve, maintain, and improve overall organisational performance and capabilities.

The application of quality management principles not only provides direct benefits but also makes an

important contribution to managing costs and risks. Benefit, cost and risk management considerations are

important for the organisation, its customers and other interested parties. These considerations on overall

performance of the organisation may impact
— customer loyalty,
— repeat business and referral,
— operational results such as revenue and market share,
— flexible and fast responses to market opportunities,
— costs and cycle times through effective and efficient use of resources,
— alignment of processes which will best achieve desired results,
— competitive advantage through improved organisational capabilities,

— understanding and motivation of people towards the organisation's goals and objectives, as well as

participation in continual improvement,

— confidence of interested parties in the effectiveness and efficiency of the organisation, as demonstrated

by the financial and social benefits from the organisation's performance, product life cycle, and reputation,

ability to create value for both the organisation and its suppliers by optimization of costs and resources as well

as flexibility and speed of joint responses to changing markets.

The goal of this Technical Report is to guide in the application of EN ISO 9004:2000 in health services

organisations with focus on patient safety and providing a generic overview of risk management in health

services.

The guidance in this document is addressed to anyone in the organisation whose work could affect the quality

of any of its processes and therefore its products or services.
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Effective risk management evolved from manufacturing and insurance industries, and is being increasingly

accepted in many countries, both in public and private sectors, as integral part of management, quality and

good practice.

It is recognised that health services is a high risk business and even though, at present, management of risk

in health services is way behind other high risk industries such as the aviation industry, management of risk

should be considered an integral part of any health services sector management reform.

Unfortunately, in health services, even though risk is managed continuously, it is not, yet, managed as

systematically as it could be and therefore all health services managers and staff should recognize the

importance of effective risk management for becoming a modus operandi in any health service institution.

Risk management is an integral part of any health service system. Specifically it provides a comprehensive

approach to patient safety, minimizing losses that can occur anytime as patient moves along the health

service system. In general it improves the use of resources and policy decision making at all levels of the

health service system.

Risk management follows a series of process steps but it is also a system with a culture of consultation and

communication. It requires a logical analysis of facts and data as well as management structures so that

culture is understood and the process is followed.

It also requires a pro-active approach. In any system where safety is critical as in health services, it is not

acceptable to wait for loss before identifying the need for improvement. Risk management involves identifying

potential problems in advance of the problem becoming critical.

Besides taking accountability of the environment, risk management includes the realisation of opportunities or

introducing new approaches where a lack of action exposes the organisation to unnecessary risks.

Risk management in health services should cover risk management activities related to:

• patient care;
• personnel;
• documentation, data and communication;
• management;
• departmental procedures;
• environment.
Risk can arise both from internals and external sources and might include:
• an adverse event during the care process;
• occurrence of an avoidable complication to the current health issue;

• occurrence of an avoidable side-effect which is not categorized as an adverse event;

• failure of equipment;
• a threat to physical safety;
• a breach of security;
• a breach of legal or contractual responsibility;
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• fraud.

This document is therefore addressed to the organisation’s top management, i.e., the organisation’s CEO, the

medical, nursing, general administration and other directors; as well as the intermediate management, i.e.

heads of administration, clinical and technical units, departments or services; and all the process owners.

Guidance is provided on how to improve the health care organisation’s performance, safety, effectiveness,

efficiency and quality of its services, in order to manage risks, reduce costs, manage risks and improve

competitiveness, therefore increasing satisfaction of customers and other interested parties.

This Technical Report can also be used for self-assessment to determine how the organisation compares to

the improvement guidelines as well as for assessing the maturity of their quality management system, and for

identification of opportunities for improvement through multidisciplinary teams. Assessment using the

EN ISO 9004:2000 criteria can be a first step towards comparison to quality award criteria such as the EFQM

Excellence Model.

Annex A of EN ISO 9004:2000 contains information about self-assessment to grade the organisation.

0.2 Process approach

This International Standard promotes the adoption of a process approach when developing, implementing and

improving the effectiveness and efficiency of a quality management system to enhance interested party

satisfaction by meeting interested party requirements.

For an organization to function effectively and efficiently, it has to identify and manage numerous linked

activities. An activity using resources, and managed in order to enable the transformation of inputs into

outputs, is considered as a process. Often the output from one process directly forms the input to the next.

The application of a system of processes within an organization, together with the identification and

interactions and managing of these processes can be referred to as the “process approach”.

An advantage of the process approach is the ongoing control that it provides over the linkage between the

individual processes within the system of processes, as well as their combination and interaction.

When used within a quality management system, such an approach emphasizes the importance of

 a) understanding and fulfilling the requirements,
 b) the need to consider processes in terms of added value,
 c) obtaining results of process performance and effectiveness, and
 d) continual improvement of processes based on objective measurement.

The model of a process-based quality management system shown in Figure 1 illustrates the process linkages

presented in clauses 4 to 8. This illustration shows that interested parties play a significant role in defining

requirements as inputs. Monitoring the satisfaction of interested parties requires the evaluation of information

relating to the perception of interested parties as to whether the organization has met their requirements. The

model shown in Figure 1 does not show processes at a detailed level.
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Figure 1—Model of a proces
...

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