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