Comparison between ISO 9001:2008 and ISO/DIS 9001:2015
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ISO 9001:2008 |
ISO 9001:2015 DIS |
Comments |
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0. Introduction |
0. Introduction |
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1.1 General |
1. Scope |
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1.2 Application |
4.3 Determining the scope of the quality management system |
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2. Normative references |
2. Normative references |
There is no normative reference in the DIS |
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3. Terms and definitions |
3. Terms and definitions |
Definitions from ISO 9001:2014 DIS included |
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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 |
4.4 Quality management system and its processes |
Reduced requirements for documentation |
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4.2.1 General |
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4.2.2 Quality Manual |
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Quality Manual not required |
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4.2.3 Control of Documents |
7.5 Documented Information |
Records and Documents are now Maintain & Retain "Documented Information |
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4.2.4 Control of Records |
7.5 Documented Information |
Records and Documents are now Maintain & Retain "Documented Information" |
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5. Management Responsibility |
5. Leadership |
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5.1 Management Commitment |
5.1.1 Leadership and commitment for the quality management system |
Top Management shall demonstrate - The risks which can affect conformity of goods and services and customer satisfaction are identified and addressed. |
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5.2 Customer Focus |
5.1.2 Customer focus |
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5.3 Quality Policy |
5.2 Quality policy |
Available to relevant interested parties, as appropriate. |
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5.4 Planning |
6. Planning |
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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 change |
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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 |
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MR not required for an individual person |
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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 Management Review |
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5.6.2 Review Input |
9.3.1 Management Review |
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5.6.3 Review Output |
9.3.2 Management Review |
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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 |
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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 |
Use of goods & services instead of products |
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7.2 Customer-Related Processes |
8.2 Determination of requirements for products and services |
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7.2.1 Determination of Requirements Related to the Product |
8.2.2 Determination 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 products and services |
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7.4.1 Purchasing Process |
8.4.1 General |
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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 of external provision |
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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 |
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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 |
7.1.5 Monitoring and measuring resources |
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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 |
9.1.3 Analysis and evaluation |
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8.3 Control of Nonconforming Product |
8.7 Control of nonconforming process outputs, products and services |
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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 Improvement |
Continual deleted |
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8.5.2 Corrective Action |
10.2 Nonconformity and corrective action |
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8.5.3 Preventive Action |
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No requirement for PA (risk based thinking) |
