In order to make ISO 9001 standard more applicable to evolving Market needs major changes have been released in new ISO 9001:2015 draft. This standard is coming out in Sept 2015. Companies will have time till 2019 to embrace the changes. Some of these changes will align major certification standards like Environmental Management System ISO 14001:2015, Asset Management System ISO 55001 and future ISO 45001 standard on occupations health and safety management.
- Higher Level Structure Change
- Risk Management as Foundation base
- Identification of Stakeholders as part of Management review
- No Quality Manual required
- No MR needed, rather a joint Leadership effort
- Context of standard is extended to service sector
- Outsourcing is now an external provision
- Enhanced emphasis on Management and Leadership
Following is side by side comparison of Clause Numbers:
| ISO 9001:2008 Clause Number | ISO 9001:2015 Clause Number |
| 0. Introduction | 0. Introduction |
| 1. Scope | 1. Scope |
| 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 | 4.1 Understanding the organization and its context |
| 4.2 Documentation Requirements | |
| 4.2.1 General | |
| 4.2.2 Quality Manual | – |
| 4.2.3 Control of Documents | 7.5 Documented Information |
| 4.2.4 Control of Records | 7.5 Documented Information |
| 5. Management Responsibility | 5. Leadership |
| 5.1 Management Commitment | |
| 5.2 Customer Focus | |
| 5.3 Quality Policy | |
| 5.4 Planning | 6. Planning |
| 5.4.1 Quality Objectives | |
| 5.4.2 Quality Management System Planning | |
| 5.5 Responsibility, Authority, and Communication | |
| 5.5.1 Responsibility and Authority | |
| 5.5.2 Management Representative | |
| 5.5.3 Internal Communications | |
| 5.6 Management Review | 9.3 Management Review |
| 5.6.1 General | |
| 5.6.2 Review Input | |
| 5.6.3 Review Output | |
| 6. Resource Management | 7. Support |
| 6.1 Provision of Resources | 7.1 Resources |
| 6.2 Human Resources | 7.2 Competence |
| 6.2.1 General | |
| 6.2.2 Competence, Training, and Awareness | |
| 6.3 Infrastructure | |
| 6.4 Work Environment | |
| 7. Product Realization | 8. Operation |
| 7.1 Planning of Product Realization | |
| 7.2 Customer-Related Processes | |
| 7.2.1 Determination of Requirements Related to the Product | |
| 7.2.2 Review of Requirements Related to the Product | |
| 7.2.3 Customer Communication | |
| 7.3 Design and Development | |
| 7.3.1 Design and Development Planning | |
| 7.3.2 Design and Development Inputs | |
| 7.3.3 Design and Development Outputs | |
| 7.3.4 Design and Development Review | |
| 7.3.5 Design and Development Verification | |
| 7.3.6 Design and Development Validation | |
| 7.3.7 Control of Design and Development Changes | |
| 7.4 Purchasing | |
| 7.4.1 Purchasing Process | |
| 7.4.2 Purchasing Information | |
| 7.4.3 Verification of Purchased Product | |
| 7.5 Production and Service Provision | |
| 7.5.1 Control of Production and Service Provision | |
| 7.5.2 Validation of Processes for Production and Service Provision | |
| 7.5.3 Identification and Traceability | 8.6.2 Identification and traceability |
| 7.5.4 Customer Property | |
| 7.5.5 Preservation of Product | 8.6.4 Preservation of goods and services |
| 7.6 Control of Monitoring and Measuring Equipment | |
| 8. Measurement, Analysis, and Improvement | 9. Performance evaluation |
| 8.1 General | |
| 8.2 Monitoring and Measurement | |
| 8.2.1 Customer Satisfaction | |
| 8.2.2 Internal Audit | 9.2 Internal Audit |
| 8.2.3 Monitoring and Measurement of Processes | |
| 8.2.4 Monitoring and Measurement of Product | |
| 8.3 Control of Nonconforming Product | |
| 8.4 Analysis of Data | |
| 8.5 Improvement | 10. Improvement |
| 8.5.1 Continual Improvement | 10.2 Improvement |
| 8.5.2 Corrective Action | 10.1 Nonconformity and corrective action |
| 8.5.3 Preventive Action |
