CEN/TS 15224:2005

Foreword
0 Introduction
  0.1 General
  0.2 Process approach
  0.3 Relationship with ISO 9004
  0.4 Compatibility with other management systems
1 Scope
  1.1 General
  1.2 Application
2 Normative reference
3 Terms and definitions
4 Quality management system
  4.1 General requirements
  4.2 Documentation requirements
5 Management responsibility
  5.1 Management commitment
  5.2 Customer focus
  5.3 Quality policy
  5.4 Planning
  5.5 Responsibility, authority and communication
  5.6 Management review
6 Resource management
  6.1 Provision of resources
  6.2 Human resources
  6.3 Infrastructure
  6.4 Work environment
7 Product realisation
  7.1 Planning of product realisation
  7.2 Customer-related processes
  7.3 Design and development
  7.4 Purchasing
  7.5 Production and service provision
  7.6 Control of monitoring and measuring devices
8 Measurement, analysis and improvement
  8.1 General
  8.2 Monitoring and measurement
  8.3 Control of non-conforming product
  8.4 Analysis of data
  8.5 Improvement
Annex A (informative) Practical guide for the implementation of
        EN ISO 9001:2000 in health care organisations
Bibliography

A quality management system is a management system to direct and control an organisation with regard to quality (ISO 9000:2000).The guide is generally applicable to the health services sector and will complement national legislation. Furthermore other national requirements, sector specific requirements and standards may complement the guide or be used in parallel.The main target groups for this guide are strategic decision-makers at all levels in the health services sector and all staff who are involved in the development, implementation and assessment of a quality management system in a health care organisation, including the stakeholders. This guide is generally applicable to all health care organisations regardless of structure, organisation, owner, size, type of service provided, locally used approaches or location. When using and adapting this guide every organisation needs to consider the nature, culture, complexity, legislation, regulation, etc. of their organisation and further specify their own requirements and use complementary national and local information. The guide also applies to the requirements of patient organisations, owners, users, insurers, inspectorates and to relevant legislation. In this manner the guide provides a basis for national requirements on health services, e.g. Provisions and Recommendations, for purchasers of health services, for contracts and agreements, and for supervision, audit, certification and accreditation in the health services sector.