1、PUBLISHED DOCUMENTPD CEN/TR 15592:2007Health services Quality management systems Guide for the use of EN ISO 9004:2000 in health services for performance improvementICS 03.120.10; 11.020g49g50g3g38g50g51g60g44g49g42g3g58g44g55g43g50g56g55g3g37g54g44g3g51g40g53g48g44g54g54g44g50g49g3g40g59g38g40g51g5
2、5g3g36g54g3g51g40g53g48g44g55g55g40g39g3g37g60g3g38g50g51g60g53g44g42g43g55g3g47g36g58PD CEN/TR 15592:2007This Published Document was published under the authority of the Standards Policy and Strategy Committee on 31 July 2007 BSI 2007ISBN 978 0 580 57980 6National forewordThis Published Document wa
3、s published by BSI. It is the UK implementation of CEN/TR 15592:2007. The UK participation in its preparation was entrusted to Technical Committee CH/100, Healthcare and medical equipment (European and International).A list of organizations represented on this committee can be obtained on request to
4、 its secretary.This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application.Amendments issued since publicationAmd. No. Date CommentsTECHNICAL REPORTRAPPORT TECHNIQUETECHNISCHER BERICHTCEN/TR 15592May 2007ICS 03.120.10; 11
5、.020English VersionHealth services - Quality management systems - Guide for theuse of EN ISO 9004:2000 in health services for performanceimprovementServices en sant - Systmes de management de laqualit - Guide dutilisation de lEN ISO 9004:2000 pourlamlioration continue des performances dans les servi
6、cesen santDienstleistungen in der Gesundheitsversorgung -Qualittsmanagementsysteme - Leitfaden fr dieAnwendung der EN ISO 9004:2000 auf dieDienstleistungen in der Gesundheitsversorgung zurLeistungsverbesserungThis Technical Report was approved by CEN on 8 April 2007. It has been drawn up by the Tech
7、nical 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, Sl
8、ovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGManagement Centre: rue de Stassart, 36 B-1050 Brussels 2007 CEN All rights of exploitation in any form and by any means reservedworldwide
9、for CEN national Members.Ref. No. CEN/TR 15592:2007: E2 Contents Page Foreword4 Introduction .6 0.1 General6 0.2 Process approach8 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 manage
10、ment system23 4.1 Managing systems and processes 23 4.2 Documentation.23 4.3 Use of quality management principles26 5 Management responsibility 29 5.1 General guidance.29 5.1.1 Introduction29 5.1.2 Issues to be considered30 5.2 Needs and expectations of interested parties 31 5.2.1 General31 5.2.2 Ne
11、eds and expectations31 5.2.3 Statutory and regulatory plans.33 5.3 Quality policy .33 5.4 Planning34 5.4.1 Quality objectives 34 5.4.2 Quality planning.35 5.5 Responsibility, authority and communication36 5.5.1 Responsibility and authority 36 5.5.2 Management representative .36 5.5.3 Internal commun
12、ication 36 5.6 Management review.37 5.6.1 General37 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 considered39 6.2 Human resources.39 6.2.3 Involvement of people.39 6.2.2 Competence, awareness and training .40 6.3 Infrastructure41 6
13、.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 Introduction44 CEN/TR 15592:20073 7.1.2 Issues to be considered44 7.1.3. Managing processes .45 7.2 Process relate
14、d to interested parties 48 7.3 Design and development49 7.3.1 Design and development planning49 7.3.2 Design and development input and output 51 7.3.3 Design and development review52 7.4 Purchasing .53 7.4.1 Purchasing process 53 7.4.2 Supplier control process 54 7.5 Production and service operation
15、s .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 product57 7.6 Control of monitoring and measuring devices.58 8 Measurement, analysis and improvement58 8.1 General guidance 58 8.1.1 Introduction58 8.1.2 Issues to be c
16、onsidered59 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-con
17、formity65 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 Performanc
18、e maturity levels72 A.3 Self-assessment questions73 A.4 Documentation of self-assessment results .82 A.5 Linking potential benefits of ISO 9004 to self-assessment83 Annex B (informative) Process for continual improvement .86 Bibliography88 CEN/TR 15592:20074 Foreword This document (CEN/TR 15592-1:20
19、07) 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 guidanc
20、e 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. E
21、ach 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 Internati
22、onal 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
23、 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 iden
24、tifying 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 revise
25、d. 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 Inte
26、rnational 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 giv
27、e 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 tex
28、t 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 90
29、01:2000 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 appl
30、y 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,
31、 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. Th
32、e 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). CEN/TR 15592:20075 This Technical Report cannot be
33、 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
34、:2000 applied to health service organisations. CEN/TR 15592:20076 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 organisations quality management system is influenced by
35、 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 st
36、ructure 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
37、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
38、 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, flexibl
39、e 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
40、 organisations 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 organisations performance, product life cycle, and reputatio
41、n, 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
42、 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. CEN/TR 15592:20077 Effect
43、ive 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,
44、 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 continuo
45、usly, 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
46、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 f
47、ollows 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 syste
48、m 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
49、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;
