ISO 9001:2015

STRUCTURE
OBJECTIVES

 Understand and outline the structure and content of ISO

9001:2015
OBJECTIVES

 Understand and outline the structure and content of ISO

9001:2015

 Understand and explain the specific quality management-related

requirements of ISO 9001:2015
ISO 9001:2015 HIGH LEVEL STRUCTURE (HLS)

 A new common format has been developed for use in all

management system standards (MSS)
 Defined in Appendix SL of the ISO/IEC Directives, Part 1

Organizations implementing multiple management systems

(e.g. quality. Environmental, information security) can
achieve better integration and easier implementation
REVISED HLS
ISO 9001:2008 ISO 9001:2015
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
5. Management Responsibility 5. Leadership
6. Resource Management 6. Planning
7. Product Realization 7. Support
8. Measurement, analysis and 8. Operation
improvement
9. Performance Evaluation
10. Improvement
STRUCTURE OF ISO 9001:2015 (1/3)

1 Scope
2 Normative references
3 Terms and definitions
4 Context of the organization
1. Understanding the organization and its context
2. Understanding the needs and expectations of interested parties
3. Determining the scope of QMS
4. Quality management system and its processes
5 Leadership
1. Leadership and commitment
2. Policy
3. Organizational roles, responsibilities and authorities
6 Planning for the QMS
1. Actions to address risks and opportunities
2. Quality objectives and planning to achieve them
3. Planning of changes
STRUCTURE OF ISO 9001:2015 (2/3)

7 Support
1. Resources
2. Competence
3. Awareness
4. Communication
5. Documented information
8 Operation
1. Operational planning and control
2. Requirements for products and services
3. Design and development of products and services
4. Control of externally provided processes, products and services
5. Production and service provision
6. Release of products and services
7. Control of nonconforming outputs
STRUCTURE OF ISO 9001:2015 (3/3)

9 Performance evaluation
1. Monitoring, measurement, analysis and evaluation
2. Internal audit
3. Management review
10Improvement
1. General
2. Nonconformity and corrective action
3. Continual improvement
THANK YOU