NEN EN ISO 13485 : 2016 C11 2017

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

Defines 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 and applicable regulatory requirements.