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CEN/TR 15592:2007

Current
Current

The latest, up-to-date edition.

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

09-05-2007

Foreword
Introduction
0.1 General
0.2 Process approach
0.3 Relationship with EN ISO 9001
0.4 Compatibility with other management systems
1 Scope
2 Normative references
3 Terms and definitions
4 Quality management system
4.1 Managing systems and processes
  4.2 Documentation
  4.3 Use of quality management principles
5 Management responsibility
  5.1 General guidance
      5.1.1 Introduction
      5.1.2 Issues to be considered
  5.2 Needs and expectations of interested parties
      5.2.1 General
      5.2.2 Needs and expectations
      5.2.3 Statutory and regulatory plans
  5.3 Quality policy
  5.4 Planning
      5.4.1 Quality objectives
      5.4.2 Quality planning
  5.5 Responsibility, authority and communication
      5.5.1 Responsibility and authority
      5.5.2 Management representative
      5.5.3 Internal communication
  5.6 Management review
      5.6.1 General
      5.6.2 Review input
      5.6.3 Review output
6 Resource management
  6.1 General guidance
      6.1.2 Issues to be considered
  6.2 Human resources
      6.2.3 Involvement of people
      6.2.2 Competence, awareness and training
  6.3 Infrastructure
  6.4 Work environment
  6.5 Information
  6.6 Suppliers and partnerships
  6.7 Natural resources
  6.8 Financial resources
7 Product realisation
  7.1 General guidance
      7.1.1 Introduction
      7.1.2 Issues to be considered
      7.1.3. Managing processes
  7.2 Process related to interested parties
  7.3 Design and development
      7.3.1 Design and development planning
      7.3.2 Design and development input and output
      7.3.3 Design and development review
  7.4 Purchasing
      7.4.1 Purchasing process
      7.4.2 Supplier control process
  7.5 Production and service operations
      7.5.1 Operation and realization
      7.5.2 Identification and traceability
      7.5.3 Customer property
      7.5.4 Preservation of product
  7.6 Control of monitoring and measuring devices
8 Measurement, analysis and improvement
  8.1 General guidance
      8.1.1 Introduction
      8.1.2 Issues to be considered
  8.2 Measurement and monitoring
      8.2.1 Measurement and monitoring of system
            performance
      8.2.2 Measurement and monitoring of processes
      8.2.3 Measurement and monitoring of products
      8.2.4 Measurement and monitoring the
            satisfaction of interested parties
  8.3 Control of non-conformity
      8.3.1 General
      8.3.2 Nonconformity review and disposition
  8.4 Analysis of data
  8.5 Improvement
      8.5.1 General
      8.5.2 Corrective action
      8.5.3 Loss prevention
      8.5.4 Continual improvement of the organisation
Annex A (informative) Guidelines for self-assessment
      A.1 Introduction
      A.2 Performance maturity levels
      A.3 Self-assessment questions
      A.4 Documentation of self-assessment
          results
      A.5 Linking potential benefits of ISO 9004
          to self-assessment
Annex B (informative) Process for continual improvement
Bibliography

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

Committee
CEN/TC 362
DocumentType
Technical Report
PublisherName
Comite Europeen de Normalisation
Status
Current

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ISO/TR 10014:1998 Guidelines for managing the economics of quality
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ISO 10015:1999 Quality management Guidelines for training
IWA 1:2005 Quality management systems Guidelines for process improvements in health service organizations
ISO/TR 10017:2003 Guidance on statistical techniques for ISO 9001:2000
ISO 10014:2006 Quality management Guidelines for realizing financial and economic benefits
ISO 10576-1:2003 Statistical methods — Guidelines for the evaluation of conformity with specified requirements — Part 1: General principles
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ISO/IEC Guide 73:2002 Risk management Vocabulary Guidelines for use in standards
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ISO/IEC 90003:2014 Software engineering Guidelines for the application of ISO 9001:2008 to computer software
ISO 10007:2017 Quality management — Guidelines for configuration management
CEN/TS 15224:2005 Health services - Quality management systems - Guide for the use of EN ISO 9001:2000
UNE 66174:2010 Guide for the assessment of management system standard for the sustained success of an organization according to UNE-EN ISO 9004:2009
EN ISO 9000:2015 Quality management systems - Fundamentals and vocabulary (ISO 9000:2015)

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