UNI EN ISO 13485 : 2004

Foreword
0 Introduction
  0.1 General
  0.2 Process approach
  0.3 Relationship with other standards
  0.4 Compatibility with other management systems
1 Scope
  1.1 General
  1.2 Application
2 Normative references
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 realization
  7.1 Planning of product realization
  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 nonconforming product
  8.4 Analysis of data
  8.5 Improvement
Annex A (informative) Correspondence between ISO 13485: 2003 and
        ISO 13485: 1996
Annex B (informative) Explanation of differences between
        ISO 13485: 2003 and ISO 9001: 2000
Bibliography

Describes the requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.