- ISO 9001:2015
- 1 Scope
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4 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
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5 Leadership
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5.1 Leadership and commitment
- 5.1.1 General
- 5.1.2 Customer focus
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5.2 Policy
- 5.2.1 Establishing the Quality Policy
- 5.2.2 Communicating the Quality Policy
- 5.3 Organizational roles, responsibilities and authorities
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6 Planning
- 6.1 Actions to address risks and opportunities
- 6.2 Quality objectives and planning to achieve them
- 6.3 Planning of changes
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7 Support
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7.1 Resources
- 7.1.1 General
- 7.1.2 People
- 7.1.3 Infrastructure
- 7.1.4 Environment for the operation of processes
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7.1.5 Monitoring and measuring resources
- 7.1.5.1 General
- 7.1.5.2 Measurement traceability
- 7.1.6 Organizational knowledge
- 7.2 Competence
- 7.3 Awareness
- 7.4 Communication
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7.5 Documented information
- 7.5.1 General
- 7.5.2 Creating and updating
- 7.5.3 Control of documented Information
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8 Operation
- 8.1 Operational planning and control
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8.2 Requirements for products and services
- 8.2.1 Customer communication
- 8.2.2 Determination of requirements for products and services
- 8.2.3 Review of the requirements for products and services
- 8.2.4 Changes to requirements for products and services
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8.3 Design and development of products and services
- 8.3.1 General
- 8.3.2 Design and development planning
- 8.3.3 Design and development inputs
- 8.3.4 Design and development controls
- 8.3.5 Design and development outputs
- 8.3.6 Design and development changes
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8.4 Control of externally provided processes, products and services
- 8.4.1 General
- 8.4.2 Type and extent of control
- 8.4.3 Information for external providers
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8.5 Production and service provision
- 8.5.1 Control of production and service provision
- 8.5.2 Identification and traceability
- 8.5.3 Property belonging to customers or external providers
- 8.5.4 Preservation
- 8.5.5 Post-delivery activities
- 8.5.6 Control of changes
- 8.6 Release of products and services
- 8.7 Control of nonconforming outputs
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9 Performance evaluation
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9.1 Monitoring, measurement, analysis and evaluation
- 9.1.1 General
- 9.1.2 Customer satisfaction
- 9.1.3 Analysis and evaluation
- 9.2 Internal audit
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9.3 Management review
- 9.3.1 General
- 9.3.2 Management review input
- 9.3.3 Management review output
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10 Improvement
- 10.1 General
- 10.2 Nonconformity and corrective action
- 10.3 Continual Improvement