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Steve Barfoot

This document outlines the key sections and processes of an ISO 9001:2015 quality management system for an organization. It includes sections on leadership and commitment, planning, support, operation, performance evaluation, and improvement. The operation section specifically addresses control of externally provided processes and products, customer communication, design and development, production and service provision, and control of nonconforming products. Planning processes incorporate determining requirements, reviewing requirements, managing changes to requirements, and controls. Performance is evaluated through monitoring, measurement, internal audits and management reviews. Improvement involves nonconformity corrective action and continual improvement.

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8.4.1 General 8.4.2 Type and extent of control 8.4.3 Information for external providers 4 Context of the organization 5 Leadership 5.1 Leadership and commitment 5.2 Policy 5.3 Organizational roles, responsibilities and authorities 9 Performance evaluation 9.1 Monitoring, measurement, analysis and evaluation 9.2 Internal Audit 9.3 Management Review 8 Operation 8.1 Operational planning and control 8.2 Requirements for products and services 8.3 Design and development of products and services Quality, Production, Planning and Scheduling 8.5 Production and service provision Customer Satisfaction 8.4 Control of externally provided processes, products and services Nonconforming Product See 10 (left) 7 Support 7.1 Resources (General, People, Infrastructure, Environment, Measuring Resources, Knowledge) 7.2 Competence 7.3 Awareness 7.4 Communication 7.5 Documented information Steve Barfoot President Advantage International (919-846-6864) 8.2.1 Customer communication 8.2.2 Determining the 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 8.3.1 General 8.3.2 Planning 8.3.3 Inputs 8.3.4 Controls 8.3.5 Outputs 8.3.6 Changes See 8.1, above 8.5.1 Control of production and service provision 8.5.2 Identification and traceability 8.5.3 Property belonging to customers and external providers 8.5.4 Preservation 8.5.5 Post-delivery activities 8.5.6 Control of changes ISO 9001:2015 Process Interaction with the Seven Quality Management Principles 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 1: Customer focus 2 2: Leadership 1 3 4 3: Engagement of people 4: Process Approach 5 5: Improvement 6: Evidence based decision making 6 7: Relationship management 7 ISO 9000 ISO 9001:2015 ISO 9004 Quality Managment System Business Model New: October 2015 10.1 General 10.2 Nonconformity and corrective action 10.3 Continual improvement 10 Improvement 1 2 5 2 5 6 7 7 3 6 Planning 6.1 Action to address risks and opportunities 6.2 Quality objectives and planning to achieve them 6.3 Planning of changes 7 2 3

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Flowchart

  • 1. 8.4.1 General 8.4.2 Type and extent of control 8.4.3 Information for external providers 4 Context of the organization 5 Leadership 5.1 Leadership and commitment 5.2 Policy 5.3 Organizational roles, responsibilities and authorities 9 Performance evaluation 9.1 Monitoring, measurement, analysis and evaluation 9.2 Internal Audit 9.3 Management Review 8 Operation 8.1 Operational planning and control 8.2 Requirements for products and services 8.3 Design and development of products and services Quality, Production, Planning and Scheduling 8.5 Production and service provision Customer Satisfaction 8.4 Control of externally provided processes, products and services Nonconforming Product See 10 (left) 7 Support 7.1 Resources (General, People, Infrastructure, Environment, Measuring Resources, Knowledge) 7.2 Competence 7.3 Awareness 7.4 Communication 7.5 Documented information Steve Barfoot President Advantage International (919-846-6864) 8.2.1 Customer communication 8.2.2 Determining the 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 8.3.1 General 8.3.2 Planning 8.3.3 Inputs 8.3.4 Controls 8.3.5 Outputs 8.3.6 Changes See 8.1, above 8.5.1 Control of production and service provision 8.5.2 Identification and traceability 8.5.3 Property belonging to customers and external providers 8.5.4 Preservation 8.5.5 Post-delivery activities 8.5.6 Control of changes ISO 9001:2015 Process Interaction with the Seven Quality Management Principles 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 1: Customer focus 2 2: Leadership 1 3 4 3: Engagement of people 4: Process Approach 5 5: Improvement 6: Evidence based decision making 6 7: Relationship management 7 ISO 9000 ISO 9001:2015 ISO 9004 Quality Managment System Business Model New: October 2015 10.1 General 10.2 Nonconformity and corrective action 10.3 Continual improvement 10 Improvement 1 2 5 2 5 6 7 7 3 6 Planning 6.1 Action to address risks and opportunities 6.2 Quality objectives and planning to achieve them 6.3 Planning of changes 7 2 3