PD CEN/TR 15592:2007

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

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.

This International Standard provides guidelines beyond the requirements given in ISO9001 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 ISO9001, 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 ISO9001.

This Technical Report provides assistance on how the EN ISO9004:2000 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 ISO9004:2000 promotes a better understanding of the EN ISO9001:2000 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 ISO9004:2000 is that it can be used for self-assessment (see AnnexA) comparing the performance of the organisation with the 290 individual “should” performance improvement guideline statements of the standard. These statements can be used to create a check list for evaluators (see A.3).

Using the EN ISO9004:2000 criteria, organisations can assess the maturity of their quality management system (see A.2) and identify opportunities for improvement.

This Technical Report ensures that those health system activities that are necessary for continuous improvement, risk management and reduction of variation and organisational waste are carried out consistently and in a controlled manner.

This Technical Report addresses any health system or health care organisation involved in the provision of health services to the population including prevention, care and rehabilitation, regardless of the type and size of the system/organisation and the product or service provided.