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.
QMS
Chapter 4.1
General Requirements
Chapter 4.2
Documentation Requirements
Chapter 5.1
Management Committment
Chapter 5.2
Customer Focus
Chapter 5.3
Quality Policy
Chapter 5.4
Planning
Chapter 5.5
Responsibility, Authority and Communication
Chapter 5.6
Management Review
Chapter 6.1
Provisions of Resources
Chapter 6.2
Human Resources
Chapter 6.3
Infrastructure
Chapter 6.4
Work environment and contamination control
Chapter 7.1
Planning of Product realization
Chapter 7.2
Customer-related processes
Chapter 7.3
Design and Development
Chapter 7.4
Purchasing
Chapter 7.5
Production and Service Provisions
Chapter 7.6
Control of monitoring and measuring equipment
Chapter 8.1
General
Chapter 8.2
Monitoring and measurement
Chapter 8.3
Control of nonconforming products
Chapter 8.4
Analysis of data
Chapter 8.5
Improvement
