Chapter 1: Setting up a Quality Management System
2
Table 1-2. Similarities Between ISO 9001 and ISO 13485
Clause in ISO 9001:2015 Clause in ISO 13485:2016
1 Scope 1 Scope
4 Context of the organization 4 Quality Management System
4.1 Understanding the Organization and its Context 4.1 General Requirements
4.2 Understanding the Needs and Expectations of Interested
Parties
4.1 General Requirements
4.3 Determining the Scope of the Quality Management System 4.1 General Requirements
4.2.2 Quality Manual
4.4 Quality Management System and its Processes 4.1 General Requirements
5 Leadership 5 Management Responsibility
5.1 Leadership and Commitment 5.1 Management Commitment
5.1.1 General 5.1 Management Commitment
5.1.2 Customer Focus 5.2 Customer Focus
5.2 Policy 5.3 Quality Policy
5.2.1 Establishing the Quality Policy 5.3 Quality Policy
5.2.2 Communicating the Quality Policy 5.3 Quality Policy
5.3 Organizational Roles, Responsibilities and Authorities 5.4.2 Quality Management System Planning
5.5.1 Responsibility and Authority
5.5.2 Management Representative
6 Planning 5.4.2 Quality Management System Planning
6.1 Actions to Address Risks and Opportunities 5.4.2 Quality Management System Planning
8.5.3 Preventive Action
6.2 Quality Objectives and Planning to Achieve Them 5.4.1 Quality Objectives
6.3 Planning of Changes 5.4.2 Quality Management System Planning
7 Support 6 Resource Management
7.1 Resources 6 Resource Management
7.1.1 General 6.1 Provision of Resources
7.1.2 People 6.2 Human Resources
7.1.3 Infrastructure 6.3 Infrastructure
7.1.4 Environment for the Operation of Processes 6.4.1 Work Environment
7.1.5 Monitoring and Measuring Resources 7.6 Control of Monitoring and Measuring Equipment
7.1.5.1 General 7.6 Control of Monitoring and Measuring Equipment
7.1.5.2 Measurement Traceability 7.6 Control of Monitoring and Measuring Equipment
7.1.6 Organizational Knowledge 6.2 Human Resources
7.2 Competence 6.2 Human Resources
7.3 Awareness 6.2 Human Resources
7.4 Communication 5.5.3 Internal Communication
7.5 Documented Information 4.2 Documentation Requirements
2
Table 1-2. Similarities Between ISO 9001 and ISO 13485
Clause in ISO 9001:2015 Clause in ISO 13485:2016
1 Scope 1 Scope
4 Context of the organization 4 Quality Management System
4.1 Understanding the Organization and its Context 4.1 General Requirements
4.2 Understanding the Needs and Expectations of Interested
Parties
4.1 General Requirements
4.3 Determining the Scope of the Quality Management System 4.1 General Requirements
4.2.2 Quality Manual
4.4 Quality Management System and its Processes 4.1 General Requirements
5 Leadership 5 Management Responsibility
5.1 Leadership and Commitment 5.1 Management Commitment
5.1.1 General 5.1 Management Commitment
5.1.2 Customer Focus 5.2 Customer Focus
5.2 Policy 5.3 Quality Policy
5.2.1 Establishing the Quality Policy 5.3 Quality Policy
5.2.2 Communicating the Quality Policy 5.3 Quality Policy
5.3 Organizational Roles, Responsibilities and Authorities 5.4.2 Quality Management System Planning
5.5.1 Responsibility and Authority
5.5.2 Management Representative
6 Planning 5.4.2 Quality Management System Planning
6.1 Actions to Address Risks and Opportunities 5.4.2 Quality Management System Planning
8.5.3 Preventive Action
6.2 Quality Objectives and Planning to Achieve Them 5.4.1 Quality Objectives
6.3 Planning of Changes 5.4.2 Quality Management System Planning
7 Support 6 Resource Management
7.1 Resources 6 Resource Management
7.1.1 General 6.1 Provision of Resources
7.1.2 People 6.2 Human Resources
7.1.3 Infrastructure 6.3 Infrastructure
7.1.4 Environment for the Operation of Processes 6.4.1 Work Environment
7.1.5 Monitoring and Measuring Resources 7.6 Control of Monitoring and Measuring Equipment
7.1.5.1 General 7.6 Control of Monitoring and Measuring Equipment
7.1.5.2 Measurement Traceability 7.6 Control of Monitoring and Measuring Equipment
7.1.6 Organizational Knowledge 6.2 Human Resources
7.2 Competence 6.2 Human Resources
7.3 Awareness 6.2 Human Resources
7.4 Communication 5.5.3 Internal Communication
7.5 Documented Information 4.2 Documentation Requirements