ISO 13485

The Quality Management System (QMS) is the applicable International Harmonized Standard for Medical Devices. The ISO 13485 consists of 8 chapters and 2 Annexes. Find here the overview of the text and Expert explanations and opinions.


Chapter 1


CHapter 2

Normative References

Chapter 3

Terms and Definitions

Chapter 4

Quality Management System

Chapter 4.1

General Requirements

Chapter 4.2

Documentation Requirements

Chapter 5

Management Responsibility

Chapter 5.1

Management Committment

Chapter 5.2

Customer Focus

Chapter 5.3

Quality Policy

Chapter 5.4


Chapter 5.5

Responsibility, Authority and Communication

Chapter 5.6

Management Review

Chapter 6

Resource Management

Chapter 6.1

Provisions of Resources

Chapter 6.2

Human Resources

Chapter 6.3


Chapter 6.4

Work environment and contamination control

Chapter 7

Product realization

Chapter 7.1

Planning of Product realization

Chapter 7.2

Customer-related processes

Chapter 7.3

Design and Development

Chapter 7.4


Chapter 7.5

Production and Service Provisions

Chapter 7.6

Control of monitoring and measuring equipment

Chapter 8

Measurement, analysis and improvement

Chapter 8.1


Chapter 8.2

Monitoring and measurement

Chapter 8.3

Control of nonconforming products

Chapter 8.4

Analysis of data

Chapter 8.5


Annex A

Comparison of content between ISO 13485:2003 and ISO 13485:2016

Annex B

Correspondence between ISO 13485:2016 and ISO 9001:2015