| 0. Introduction | 0. Introduction |
| 1.1 General | 1 Scope |
| 1.2 Application | 4.3 Determining the scope of the quality management system | |
| 2. Normative references | 2 Normative references | |
| 3. Terms and definitions | 3 Terms and definitions | |
| 4. Quality Management System | 4 Context of the organization | |
| 4.1 General Requirements | 4.4 Quality management system and its processes | |
| 4.2 Documentation Requirements | 7.5 Documented information | Reduced requirements for documentation |
| 4.2.1 General | 7.5.1 General |
| 4.2.2 Quality Manual | – | Quality Manual not required |
| 4.2.3 Control of Documents | 7.5 Documented Information | Records and Documents are now “Documented Information“ |
| 4.2.4 Control of Records | 7.5 Documented Information | Records and Documents are now “Documented Information“ |
| 5. Management Responsibility | 5 Leadership |
| 5.1 Management Commitment | 5.1 Leadership and commitment | |
| 5.2 Customer Focus | 5.1.2 Customer focus | |
| 5.3 Quality Policy | 5.2 Policy | |
| 5.4 Planning | 6 Planning |
| 5.4.1 Quality Objectives | 6.2 Quality objectives and planning to achieve them | |
| 5.4.2 Quality Management System Planning | 6.3 Planning of changes | |
| 5.5 Responsibility, Authority, and Communication | 5.3 Organizational roles, responsibilities and authorities | |
| 5.5.1 Responsibility and Authority | 5.3 Organizational roles, responsibilities and authorities | |
| 5.5.2 Management Representative | – | MR not required |
| 5.5.3 Internal Communications | 7.4 Communication | |
| 5.6 Management Review | 9.3 Management Review | |
| 5.6.1 General | 9.3.1 General | |
| 5.6.2 Review Input | 9.3.2 Management Review Inputs | |
| 5.6.3 Review Output | 9.3.3 Management Review Outputs | |
| 6. Resource Management | 7.1 Resources | |
| 6.1 Provision of Resources | 7.1 Resources | |
| 6.2 Human Resources | 7.1.2 People | |
| 6.2.1 General | 7.2 Competence | |
| 6.2.2 Competence, Training, and Awareness | 7.2 Competence and 7.3 Awareness | |
| 6.3 Infrastructure | 7.1.3 Infrastructure | |
| 6.4 Work Environment | 7.1.4 Environment for the operation of processes | |
| 7. Product Realization | 8 Operation | |
| 7.1 Planning of Product Realization | 8.1 Operational planning and control | |
| 7.2 Customer-Related Processes | 8.2 Requirements for products and services | |
| 7.2.1 Determination of Requirements Related to the Product | 8.2.2 Determining of requirements related to products and services | |
| 7.2.2 Review of Requirements Related to the Product | 8.2.3 Review of requirements related to products and services | |
| 7.2.3 Customer Communication | 8.2.1 Customer communication | |
| 7.3 Design and Development | 8.3 Design and development of products and services | |
| 7.3.1 Design and Development Planning | 8.3.2 Design and development planning | |
| 7.3.2 Design and Development Inputs | 8.3.3 Design and development inputs | |
| 7.3.3 Design and Development Outputs | 8.3.5 Design and development outputs | |
| 7.3.4 Design and Development Review | 8.3.4 Design and development controls | |
| 7.3.5 Design and Development Verification | 8.3.4 Design and development controls | |
| 7.3.6 Design and Development Validation | 8.3.4 Design and development controls | |
| 7.3.7 Control of Design and Development Changes | 8.3.6 Design and development changes | |
| 7.4 Purchasing | 8.4 Control of externally provided processes, products and services | |
| 7.4.1 Purchasing Process | 8.4.1 General | |
| 7.4.2 Purchasing Information | 8.4.3 Information for external providers | |
| 7.4.3 Verification of Purchased Product | 8.4.2 Type and extent of control and 8.6 Release of products and services | |
| 7.5 Production and Service Provision | 8.5 Production and service provision | |
| 7.5.1 Control of Production and Service Provision | 8.5.1 Control of production and service provision | |
| 7.5.2 Validation of Processes for Production and Service Provision | 8.5.1 Control of production and service provision | |
| 7.5.3 Identification and Traceability | 8.5.2 Identification and traceability |
| 7.5.4 Customer Property | 8.5.3 Property belonging to customers or external providers | |
| 7.5.5 Preservation of Product | 8.5.4 Preservation | |
| 7.6 Control of Monitoring and Measuring Equipment | 8.5.1 Control of production and service provision | |
| 8. Measurement, Analysis, and Improvement | 9.1 Monitoring, measurement, analysis and evaluation | |
| 8.1 General | 9.1.1 General | |
| 8.2 Monitoring and Measurement | 9.1.1 General | |
| 8.2.1 Customer Satisfaction | 9.1.2 Customer satisfaction | |
| 8.2.2 Internal Audit | 9.2 Internal Audit | |
| 8.2.3 Monitoring and Measurement of Processes | 9.1.3 Analysis and evaluation | |
| 8.2.4 Monitoring and Measurement of Product | 8.6 Release of products and services | |
| 8.3 Control of Nonconforming Product | 8.7 Control of nonconforming outputs | |
| 8.4 Analysis of Data | 9.1.3 Analysis and evaluation | |
| 8.5 Improvement | 10 Improvement | |
| 8.5.1 Continual Improvement | 10.3 Continual improvement | Continual deleted in CD, but is back in the revised standard |
| 8.5.2 Corrective Action | 10.2 Nonconformity and corrective action | |
| 8.5.3 Preventive Action | 6.1 Actions to address risks and opportunities | PA is being replaced with risk based thinking |
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