The new revision of ISO 9001-2015 Quality Management System Standard has been published by ISO (International Standardization Organisation). The new version has significant changes, that’s why it is hard to adopt both to documentation and implementation systems of various companies. Below you can find the new ISO 9001-2015 Structure
- Scope
- Normative references
- Terms and definitions
- Context of the organization
4.1 Understanding the organization and its context
4.2 Understanding the needs and expectations of interested parties
4.3 Determining the scope of the quality management system
4.4 Quality management system and its processes
- Leadership
5.1 Leadership and commitment
5.2 Policy
5.3 Organizational roles, responsibilities and authorities
- Planning
6.1 Actions to address risks and opportunities
6.2 Quality objectives and planning to achieve them
6.3 Planning of changes
- Support
7.1 Resources
7.2 Competence
7.3 Awareness
7.4 Communication
7.5 Documented information
- Operation
8.1 Operational planning and control
8.2 Requirements for products and services
8.3 Design and development of products and services
8.4 Control of externally provided processes, products and services
8.5 Production and service provision
8.6 Release of products and services
8.7 Control of nonconforming outputs
- Performance evaluation
9.1 Monitoring, measurement, analysis and evaluation
9.2 Internal audit
9.3 Management review
- Improvement
10.1 General
10.2 Nonconformity and corrective action
10.3 Continual improvement
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