Chapter 1: Setting up a Quality Management System
6
Table 1-3. Comparison of ISO 13485:2003 and ISO 13485:2016
ISO 13485:2003 ISO 13485:2016
4 Quality Management System 4 Quality Management System
4.1 General Requirements 4.1 General Requirements
4.2 Documentation Requirements 4.2 Documentation Requirements
4.2.1 General 4.2.1 General
4.2.2 Quality Manual 4.2.2 Quality Manual
***4.2.3 Medical Device File
4.2.3 Control of Documents 4.2.4 Control of Documents
4.2.4 Control of Records 4.2.5 Control of Records
5 Management Responsibility 5 Management Responsibility
5.1 Management Commitment 5.1 Management Commitment
5.2 Customer Focus 5.2 Customer Focus
5.3 Quality Policy 5.3 Quality Policy
5.4 Planning 5.4 Planning
5.4.1 Quality Objectives 5.4.1 Quality Objectives
5.4.2 Quality Management System Planning 5.4.2 Quality Management System Planning
5.5 Responsibility, Authority and Communication 5.5 Responsibility, Authority and Communication
5.5.1 Responsibility and Authority 5.5.1 Responsibility and Authority
5.5.2 Management Representative 5.5.2 Management Representative
5.5.3 Internal Communication 5.5.3 Internal Communication
5.6 Management Review 5.6 Management Review
5.6.1 General 5.6.1 General
5.6.2 Review Input 5.6.2 Review Input
5.6.3 Review Output 5.6.3 Review Output
6 Resource Management 6 Resource Management
6.1 Provision of Resources 6.1 Provision of Resources
6.2 Human Resources 6.2 Human Resources
6.2.1 General ***
6.2.2 Competence, Awareness, and Training ***
6.3 Infrastructure 6.3 Infrastructure
6.4 Work Environment 6.4 Work Environment and Contamination Control
***6.4.1 Work Environment
***6.4.2 Contamination Control
7 Product Realization 7 Product Realization
7.1 Planning of Product Realization 7.1 Planning of Product Realization
7.2 Customer-Related Processes 7.2 Customer-Related Processes
7.2.1 Determination of Requirements Related to the Product 7.2.1 Determination of Requirements Related to the Product
7.2.2 Review of Requirements Related to Product 7.2.2 Review of Requirements Related to Product
7.2.3 Customer Communication 7.2.3 Communication
7.3 Design and Development 7.3 Design and Development
6
Table 1-3. Comparison of ISO 13485:2003 and ISO 13485:2016
ISO 13485:2003 ISO 13485:2016
4 Quality Management System 4 Quality Management System
4.1 General Requirements 4.1 General Requirements
4.2 Documentation Requirements 4.2 Documentation Requirements
4.2.1 General 4.2.1 General
4.2.2 Quality Manual 4.2.2 Quality Manual
***4.2.3 Medical Device File
4.2.3 Control of Documents 4.2.4 Control of Documents
4.2.4 Control of Records 4.2.5 Control of Records
5 Management Responsibility 5 Management Responsibility
5.1 Management Commitment 5.1 Management Commitment
5.2 Customer Focus 5.2 Customer Focus
5.3 Quality Policy 5.3 Quality Policy
5.4 Planning 5.4 Planning
5.4.1 Quality Objectives 5.4.1 Quality Objectives
5.4.2 Quality Management System Planning 5.4.2 Quality Management System Planning
5.5 Responsibility, Authority and Communication 5.5 Responsibility, Authority and Communication
5.5.1 Responsibility and Authority 5.5.1 Responsibility and Authority
5.5.2 Management Representative 5.5.2 Management Representative
5.5.3 Internal Communication 5.5.3 Internal Communication
5.6 Management Review 5.6 Management Review
5.6.1 General 5.6.1 General
5.6.2 Review Input 5.6.2 Review Input
5.6.3 Review Output 5.6.3 Review Output
6 Resource Management 6 Resource Management
6.1 Provision of Resources 6.1 Provision of Resources
6.2 Human Resources 6.2 Human Resources
6.2.1 General ***
6.2.2 Competence, Awareness, and Training ***
6.3 Infrastructure 6.3 Infrastructure
6.4 Work Environment 6.4 Work Environment and Contamination Control
***6.4.1 Work Environment
***6.4.2 Contamination Control
7 Product Realization 7 Product Realization
7.1 Planning of Product Realization 7.1 Planning of Product Realization
7.2 Customer-Related Processes 7.2 Customer-Related Processes
7.2.1 Determination of Requirements Related to the Product 7.2.1 Determination of Requirements Related to the Product
7.2.2 Review of Requirements Related to Product 7.2.2 Review of Requirements Related to Product
7.2.3 Customer Communication 7.2.3 Communication
7.3 Design and Development 7.3 Design and Development