Description
This standard specifies requirements for a quality management system when an organization needs to demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements.
Supersedes SZNS ISO 9001:2008 Quality Management System- Requirements.
TABLE OF CONTENTS
| Contents | Page |
| 1 Scope | 1 |
| 2 Normative references | 1 |
| 3 Terms and definitions | 1 |
| 4 Context of the organization | 1 |
| 4.1 Understanding the organization and its context | 1 |
| 4.2 Understanding the needs and expectations of interested parties | 1 |
| 4.3 Determining the scope of the quality management system | 2 |
| 4.4 Quality management system and its processes | 2 |
| 5 Leadership | 3 |
| 5.1 Leadership and commitment | 3 |
| 5.1.1 General | 3 |
| 5.1.2 Customer focus | 3 |
| 5.2 Policy | 3 |
| 5.2.1 Establishing the quality policy | 3 |
| 5.2.2 Communicating the quality policy | 3 |
| 5.3 Organizational roles, responsibilities and authorities | 4 |
| 6 Planning | 4 |
| 6.1 Actions to address risks and opportunities | 4 |
| 6.2 Quality objectives and planning to achieve them | 5 |
| 6.3 Planning of changes | 5 |
| 7 Support | 5 |
| 7.1 Resources | 5 |
| 7.1.1 General | 5 |
| 7.1.2 People | 5 |
| 7.1.3 Infastructure | 6 |
| 7.1.4 Environment for the operation of processes | 6 |
| 7.1.5 Monitoring and measuring resources | 6 |
| 7.1.6 Organizational knowledge | 6 |
| 7.2 Competence | 7 |
| 7.3 Awareness | 7 |
| 7.4 Communication | 7 |
| 7.5 Documented information | 7 |
| 7.5.1 General | 7 |
| 7.5.2 Creating and updating | 8 |
| 7.5.3 Control of documented information | 8 |
| 8 Operation | 8 |
| 8.1 Operational planning and control | 8 |
| 8.2 Requirements for products and services | 9 |
| 8.2.1 Customer communication | 9 |
| 8.2.2 Determining the requirements for products and services | 9 |
| 8.2.3 Review of the requirements for products and services | 9 |
| 8.2.4 Changes to requirements for products and services | 10 |
| 8.3 Design and development of products and services | 10 |
| 8.3.1 General | 10 |
| 8.3.2 Design and development planning | 10 |
| 8.3.3 Design and development inputs | 10 |
| 8.3.4 Design and development controls | 11 |
| 8.3.5 Design and development outputs | 11 |
| 8.3.6 Design and development changes | 11 |
| 8.4 Control of externally provided processes, products and services | 11 |
| 8.4.1 General | 11 |
| 8.4.2 Type and extent of control | 12 |
| 8.4.3 Information for external providers | 12 |
| 8.5 Production and service provision | 13 |
| 8.5.1 Control of production and service provision | 13 |
| 8.5.2 Identification and traceability | 13 |
| 8.5.3 Property belonging to customers or external providers | 13 |
| 8.5.4 Preservation | 13 |
| 8.5.5 Post-delivery activities | 14 |
| 8.5.6 Control of changes | 14 |
| 8.6 Release of products and services | 14 |
| 8.7 Control of nonconforming outputs | 14 |
| 9 Performance evaluation | 15 |
| 9.1 Monitoring, measurement, analysis and evaluation | 15 |
| 9.1.1 General | 15 |
| 9.1.2 Customer satisfaction | 15 |
| 9.1.3 Analysis and evaluation | 15 |
| 9.2 Internal audit | 15 |
| 9.3 Management review | 16 |
| 9.3.1 General | 16 |
| 9.3.2 Management review inputs | 16 |
| 9.3.3 Management review outputs | 16 |
| 10 Improvement | 17 |
| 10.1 General | 17 |
| 10.2 Nonconformity and corrective action | 17 |
| 10.3 Continual improvement | 17 |
| Annex A (informative) Clarification of new structure, terminology and concepts | 18 |
| Annex B (informative) Other International Standards on quality management and quality management systems developed by ISO/TC 176 | 22 |
| Bibliography | 26 |